Post-Operative Atrial Fibrillation
Conditions
Brief summary
This was a multi-center, randomized, double-blind, placebo-controlled, parallel group, dose-ranging study to evaluate the efficacy and safety of botulinum toxin type A (AGN-151607) injections into the epicardial fat pads, foci of ganglionic plexi, to prevent Post-Operative Atrial Fibrillation (POAF) in patients undergoing open-chest cardiac surgery.
Interventions
DRUGAGN-151607
Injections were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.
DRUGPlacebo
Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment.
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
55 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria: * Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form. * Written informed consent from the participant has been obtained prior to any study-related procedures * Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable (eg. Written Authorization for Use and Release of Health and Research Study Information \[US sites\] and written Data Protection consent (European Union sites). * Participants who are scheduled to undergo open-chest cardiac surgery. Includes: coronary artery bypass graft (CABG) and/or valve repair/replacement. Inclusionary valve repair/replacement procedures for the primary reason for surgery include: Aortic valve repair/replacement, Mitral valve repair/replacement, Combination of aortic and tricuspid valve repair/replacement, Combination of mitral and tricuspid valve repair/replacement CABG/valve combination procedures (when valvular procedure is one of the 4 sub-bulleted procedures immediately above), Left Atrial Appendage (LAA) procedures are allowed if CABG and/or valve repair or replacement is the qualifying surgical procedure, but is not a qualifying surgical procedure on its own. * A male participant must agree to use contraception until Day 60 and refrain from donating sperm during this period. * A female participant is eligible to participate if she is not pregnant (has a negative urine pregnancy result prior to randomization) not breastfeeding, and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP). A WOCBP who agrees to follow the contraceptive guidance until after Day 60. * In sinus rhythm for the last 48 hours prior to randomization based on standard-of care assessments and study ECGs (note: continuous ECG monitoring for 48 hours is not required; prior history of paroxysmal AF is acceptable) * Willing to wear an electrocardiogram (ECG) patch for a full 30 days post-surgery and for 7 days after each study visit * Able, as assessed by the investigator, and willing to follow study instructions and likely to complete required study visit.
Exclusion criteria
* Any uncontrolled clinically significant medical condition other than the one under study that, in the investigator's opinion, would put the participant at an unacceptable risk with exposure to botulinum toxin type A. * Exclusionary valve repair/replacement procedures include: Combination of aortic and mitral valve repair/replacement, Isolated tricuspid valve repair/replacement. * Any medical condition that may put the participant at increased risk with exposure to botulinum toxin type A, including diagnosed muscular dystrophy (eg, Duchenne's muscular dystrophy), myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, mitochondrial disease, or any other significant disease which might interfere with neuromuscular function. * Participants with presence or history of any of the following within 3 months prior to the Day 1 visit that may indicate a vulnerable respiratory state per the investigator's clinical judgment: aspiration pneumonia, lower respiratory tract infections, uncontrolled asthma, severe chronic obstructive pulmonary disease, or otherwise compromised respiratory function. * Permanent/persistent atrial fibrillation (AF) * Has a known allergy or sensitivity to any botulinum toxin type A preparation. - Has a known allergy or sensitivity to medical adhesive (eg, ECG patch adhesive; hydrogel-based adhesive). * Severe (\> 55 mm left atrial diameter) left atrial enlargement * Left ventricular ejection fraction (LVEF) \< 25% * Presence or history of symptomatic atrioventricular block \> 1st degree within the last 30 days (note: presence of a pacemaker is not exclusionary per se) - Class I or III antiarrhythmic drugs unless proper washout was documented * Botulinum toxin type A (of any serotype) use within 6 months of randomization * Has been immunized for any botulinum toxin type A serotype as determined by participant medical history * Preoperative need for inotropes/vasopressors or intra-aortic balloon pump * Prior open-chest, sternotomy cardiac surgery - History of ablation for AF * Planned ablation procedure for AF at the time of surgery * Emergency surgery * Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study * Participants have diagnostic assessments which in the opinion of the investigator prevent participation in the study * Impaired prognosis defined as EuroSCORE II \> 7% perioperative mortality at screening is exclusionary. * Females who are pregnant, nursing, or planning a pregnancy during the study * The participant has a condition or is in a situation which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 30 Seconds During the First 30 Days Post-surgery | First 30 days following the initial intensive care unit (ICU) admission date after open-chest cardiac surgery. | At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With at Least 1 Event of Symptomatic AF (Atrial Fibrillation or Atrial Flutter) During the First 30 Days Post-surgery | First 30 days following the initial ICU admission date after open-chest cardiac surgery. | At least 1 event of symptomatic AF (atrial fibrillation or atrial flutter) (symptoms occurring within 2 hours of an AF episode). For symptomatic AF, symptoms that occur in the interval that starts two hours prior to the onset of the AF episode and ends two hours after the conclusion of the AF episode will meet the definition of within 2 hours of an AF episode. AF episode ≥ 30 seconds. |
| Time to First Occurrence of AF (Atrial Fibrillation or Atrial Flutter) During the First 30 Days Post-surgery | First 30 days following the initial ICU admission date after open-chest cardiac surgery. | Amount of time (days) to first AF (atrial fibrillation or atrial flutter) occurrence defined by first episode of AF lasting for ≥ 30 seconds. |
| Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 2 Minutes During the First 30 Days Post-surgery | First 30 days following the initial ICU admission date after open-chest cardiac surgery. | At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 2 minutes documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. |
| Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 5 Minutes During the First 30 Days Post-surgery | First 30 days following the initial ICU admission date after open-chest cardiac surgery. | At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 5 minutes documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. |
| Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 6 Minutes During the First 30 Days Post-surgery | First 30 days following the initial ICU admission date after open-chest cardiac surgery. | At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 6 minutes documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. |
| Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 30 Minutes During the First 30 Days Post-surgery | First 30 days following the initial ICU admission date after open-chest cardiac surgery. | At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 30 minutes documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. |
| Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 1 Hour During the First 30 Days Post-surgery | First 30 days following the initial ICU admission date after open-chest cardiac surgery. | At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 1 hour documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. |
| Percentage of Time Spent in Atrial Fibrillation or Atrial Flutter (AF Burden) During the First 30 Days Post-surgery | First 30 days following the initial ICU admission date after open-chest cardiac surgery. | The proportion of time an individual is in AF (atrial fibrillation or atrial flutter) during a monitoring period (expressed as a percentage) calculated as (the total time spent in AF during the first 30 days post-surgery divided by the total time of analyzable data obtained from the ECG patch during the first 30 days post-surgery) multiplied by 100. The calculation excludes continuous AF episodes \< 30 seconds in duration. |
| Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 6 Hours During the First 30 Days Post-surgery | First 30 days following the initial ICU admission date after open-chest cardiac surgery. | At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 6 hours documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. |
| Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 12 Hours During the First 30 Days Post-surgery | First 30 days following the initial ICU admission date after open-chest cardiac surgery. | At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 12 hours documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. |
| Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 24 Hours During the First 30 Days Post-surgery | First 30 days following the initial ICU admission date after open-chest cardiac surgery. | At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 24 hours documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. |
| Percentage of Participants With at Least 1 Continuous Atrial Fibrillation (Excluding Atrial Flutter) Episode ≥ 30 Seconds During the First 30 Days Post-surgery | First 30 days following the initial ICU admission date after open-chest cardiac surgery. | At least one episode of continuous atrial fibrillation (excluding atrial flutter) sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. |
| Percentage of Participants With at Least 1 Continuous Atrial Flutter Episode ≥ 30 Seconds During the First 30 Days Post-surgery | First 30 days following the initial ICU admission date after open-chest cardiac surgery. | At least one episode of continuous atrial flutter sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. |
| Percentage of Participants With at Least 1 Continuous Atrial Tachycardia Episode (Defined as the Duration of the Longest Supraventricular Tachycardia [SVT] Run) ≥ 30 Seconds During the First 30 Days Post-surgery | First 30 days following the initial ICU admission date after open-chest cardiac surgery. | At least one episode of continuous atrial tachycardia sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. |
| Percentage of Participants With at Least 1 Continuous Episode of Either Atrial Fibrillation or Atrial Flutter or Atrial Tachycardia ≥ 30 Seconds During the First 30 Days Post-surgery | First 30 days following the initial ICU admission date after open-chest cardiac surgery. | At least one episode of continuous atrial fibrillation or atrial flutter or atrial tachycardia sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. |
| Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 4 Hours During the First 30 Days Post-surgery | First 30 days following the initial ICU admission date after open-chest cardiac surgery. | At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 4 hours documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest. |
Countries
Austria, Canada, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom, United States
Participant flow
Pre-assignment details
A total of 323 subjects were randomized, of which 319 received study drug (Safety Population).
Participants by arm
| Arm | Count |
|---|---|
| Placebo Injections of placebo were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment. | 105 |
| AGN-151607 (125 U) Injections of 25 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment. | 105 |
| AGN-151607 (250 U) Injections of 50 U were made into each 1 of 5 fat pads. The total injection volume into each fat pad was 1 mL. One-time treatment. | 109 |
| Total | 319 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Randomized Population | Did Not Receive Treatment | 3 | 1 | 0 |
| Treated (Safety) Population | Adverse Event | 1 | 1 | 0 |
| Treated (Safety) Population | Death | 1 | 0 | 2 |
| Treated (Safety) Population | Lost to Follow-up | 5 | 9 | 8 |
| Treated (Safety) Population | Withdrawal by Subject | 4 | 8 | 6 |
Baseline characteristics
| Characteristic | Placebo | AGN-151607 (125 U) | AGN-151607 (250 U) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 62 Participants | 63 Participants | 64 Participants | 189 Participants |
| Age, Categorical Between 18 and 65 years | 43 Participants | 42 Participants | 45 Participants | 130 Participants |
| Age, Continuous | 66.8 years STANDARD_DEVIATION 6.76 | 66.8 years STANDARD_DEVIATION 6.54 | 67.2 years STANDARD_DEVIATION 7.01 | 66.9 years STANDARD_DEVIATION 6.76 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 8 Participants | 6 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 99 Participants | 97 Participants | 103 Participants | 299 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 102 Participants | 102 Participants | 105 Participants | 309 Participants |
| Sex: Female, Male Female | 14 Participants | 17 Participants | 22 Participants | 53 Participants |
| Sex: Female, Male Male | 91 Participants | 88 Participants | 87 Participants | 266 Participants |
| Type of Surgery CABG and Valve Surgery | 13 Participants | 13 Participants | 12 Participants | 38 Participants |
| Type of Surgery Isolated Coronary Artery Bypass Graft (CABG) Surgery | 65 Participants | 68 Participants | 70 Participants | 203 Participants |
| Type of Surgery Valve only Surgery | 27 Participants | 24 Participants | 27 Participants | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 108 | 0 / 106 | 2 / 109 |
| other Total, other adverse events | 86 / 105 | 84 / 105 | 94 / 109 |
| serious Total, serious adverse events | 36 / 105 | 38 / 105 | 28 / 109 |
Outcome results
Primary
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 30 Seconds During the First 30 Days Post-surgery
At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.
Time frame: First 30 days following the initial intensive care unit (ICU) admission date after open-chest cardiac surgery.
Population: All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 30 Seconds During the First 30 Days Post-surgery | 46.1 percentage of participants |
| AGN-151607 (125 U) | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 30 Seconds During the First 30 Days Post-surgery | 36.5 percentage of participants |
| AGN-151607 (250 U) | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 30 Seconds During the First 30 Days Post-surgery | 47.2 percentage of participants |
Comparison: P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).p-value: 0.161295% CI: [0.58, 1.1]Cochran-Mantel-Haenszel
Comparison: P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).p-value: 0.778995% CI: [0.79, 1.37]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 12 Hours During the First 30 Days Post-surgery
At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 12 hours documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.
Time frame: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Population: All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 12 Hours During the First 30 Days Post-surgery | 15.7 percentage of participants |
| AGN-151607 (125 U) | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 12 Hours During the First 30 Days Post-surgery | 14.4 percentage of participants |
| AGN-151607 (250 U) | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 12 Hours During the First 30 Days Post-surgery | 17.0 percentage of participants |
Comparison: P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).p-value: 0.80495% CI: [0.49, 1.73]Cochran-Mantel-Haenszel
Comparison: P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).p-value: 0.757395% CI: [0.61, 1.98]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 1 Hour During the First 30 Days Post-surgery
At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 1 hour documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.
Time frame: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Population: All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 1 Hour During the First 30 Days Post-surgery | 37.3 percentage of participants |
| AGN-151607 (125 U) | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 1 Hour During the First 30 Days Post-surgery | 29.8 percentage of participants |
| AGN-151607 (250 U) | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 1 Hour During the First 30 Days Post-surgery | 37.7 percentage of participants |
Comparison: P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).p-value: 0.254995% CI: [0.55, 1.18]Cochran-Mantel-Haenszel
Comparison: P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).p-value: 0.854495% CI: [0.73, 1.45]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 24 Hours During the First 30 Days Post-surgery
At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 24 hours documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.
Time frame: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Population: All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 24 Hours During the First 30 Days Post-surgery | 9.8 percentage of participants |
| AGN-151607 (125 U) | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 24 Hours During the First 30 Days Post-surgery | 6.7 percentage of participants |
| AGN-151607 (250 U) | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 24 Hours During the First 30 Days Post-surgery | 12.3 percentage of participants |
Comparison: P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).p-value: 0.406595% CI: [0.28, 1.67]Cochran-Mantel-Haenszel
Comparison: P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).p-value: 0.525795% CI: [0.6, 2.7]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 2 Minutes During the First 30 Days Post-surgery
At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 2 minutes documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.
Time frame: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Population: All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 2 Minutes During the First 30 Days Post-surgery | 45.1 percentage of participants |
| AGN-151607 (125 U) | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 2 Minutes During the First 30 Days Post-surgery | 35.6 percentage of participants |
| AGN-151607 (250 U) | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 2 Minutes During the First 30 Days Post-surgery | 46.2 percentage of participants |
Comparison: P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).p-value: 0.162395% CI: [0.57, 1.1]Cochran-Mantel-Haenszel
Comparison: P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).p-value: 0.777695% CI: [0.78, 1.39]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 30 Minutes During the First 30 Days Post-surgery
At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 30 minutes documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.
Time frame: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Population: All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 30 Minutes During the First 30 Days Post-surgery | 38.2 percentage of participants |
| AGN-151607 (125 U) | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 30 Minutes During the First 30 Days Post-surgery | 30.8 percentage of participants |
| AGN-151607 (250 U) | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 30 Minutes During the First 30 Days Post-surgery | 39.6 percentage of participants |
Comparison: P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).p-value: 0.257895% CI: [0.55, 1.18]Cochran-Mantel-Haenszel
Comparison: P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).p-value: 0.752695% CI: [0.76, 1.47]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 4 Hours During the First 30 Days Post-surgery
At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 4 hours documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.
Time frame: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Population: All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 4 Hours During the First 30 Days Post-surgery | 32.4 percentage of participants |
| AGN-151607 (125 U) | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 4 Hours During the First 30 Days Post-surgery | 24.0 percentage of participants |
| AGN-151607 (250 U) | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 4 Hours During the First 30 Days Post-surgery | 26.4 percentage of participants |
Comparison: P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).p-value: 0.171895% CI: [0.48, 1.14]Cochran-Mantel-Haenszel
Comparison: P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).p-value: 0.380195% CI: [0.54, 1.27]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 5 Minutes During the First 30 Days Post-surgery
At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 5 minutes documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.
Time frame: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Population: All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 5 Minutes During the First 30 Days Post-surgery | 44.1 percentage of participants |
| AGN-151607 (125 U) | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 5 Minutes During the First 30 Days Post-surgery | 34.6 percentage of participants |
| AGN-151607 (250 U) | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 5 Minutes During the First 30 Days Post-surgery | 46.2 percentage of participants |
Comparison: P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).p-value: 0.160395% CI: [0.56, 1.1]Cochran-Mantel-Haenszel
Comparison: P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).p-value: 0.670695% CI: [0.8, 1.42]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 6 Hours During the First 30 Days Post-surgery
At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 6 hours documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.
Time frame: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Population: All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 6 Hours During the First 30 Days Post-surgery | 25.5 percentage of participants |
| AGN-151607 (125 U) | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 6 Hours During the First 30 Days Post-surgery | 22.1 percentage of participants |
| AGN-151607 (250 U) | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 6 Hours During the First 30 Days Post-surgery | 20.8 percentage of participants |
Comparison: P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).p-value: 0.553195% CI: [0.54, 1.39]Cochran-Mantel-Haenszel
Comparison: P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).p-value: 0.421395% CI: [0.51, 1.33]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 6 Minutes During the First 30 Days Post-surgery
At least one episode of continuous AF (atrial fibrillation or atrial flutter) sustained ≥ 6 minutes documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.
Time frame: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Population: All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 6 Minutes During the First 30 Days Post-surgery | 43.1 percentage of participants |
| AGN-151607 (125 U) | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 6 Minutes During the First 30 Days Post-surgery | 33.7 percentage of participants |
| AGN-151607 (250 U) | Percentage of Participants With at Least 1 Continuous AF (Atrial Fibrillation or Atrial Flutter) Episode ≥ 6 Minutes During the First 30 Days Post-surgery | 45.3 percentage of participants |
Comparison: P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).p-value: 0.158395% CI: [0.55, 1.1]Cochran-Mantel-Haenszel
Comparison: P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).p-value: 0.669495% CI: [0.8, 1.43]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With at Least 1 Continuous Atrial Fibrillation (Excluding Atrial Flutter) Episode ≥ 30 Seconds During the First 30 Days Post-surgery
At least one episode of continuous atrial fibrillation (excluding atrial flutter) sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.
Time frame: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Population: All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With at Least 1 Continuous Atrial Fibrillation (Excluding Atrial Flutter) Episode ≥ 30 Seconds During the First 30 Days Post-surgery | 43.1 percentage of participants |
| AGN-151607 (125 U) | Percentage of Participants With at Least 1 Continuous Atrial Fibrillation (Excluding Atrial Flutter) Episode ≥ 30 Seconds During the First 30 Days Post-surgery | 33.7 percentage of participants |
| AGN-151607 (250 U) | Percentage of Participants With at Least 1 Continuous Atrial Fibrillation (Excluding Atrial Flutter) Episode ≥ 30 Seconds During the First 30 Days Post-surgery | 42.5 percentage of participants |
Comparison: P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).p-value: 0.161295% CI: [0.55, 1.11]Cochran-Mantel-Haenszel
Comparison: P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).p-value: 0.996695% CI: [0.74, 1.35]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With at Least 1 Continuous Atrial Flutter Episode ≥ 30 Seconds During the First 30 Days Post-surgery
At least one episode of continuous atrial flutter sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.
Time frame: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Population: All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With at Least 1 Continuous Atrial Flutter Episode ≥ 30 Seconds During the First 30 Days Post-surgery | 12.7 percentage of participants |
| AGN-151607 (125 U) | Percentage of Participants With at Least 1 Continuous Atrial Flutter Episode ≥ 30 Seconds During the First 30 Days Post-surgery | 8.7 percentage of participants |
| AGN-151607 (250 U) | Percentage of Participants With at Least 1 Continuous Atrial Flutter Episode ≥ 30 Seconds During the First 30 Days Post-surgery | 15.1 percentage of participants |
Comparison: P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).p-value: 0.337495% CI: [0.3, 1.52]Cochran-Mantel-Haenszel
Comparison: P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).p-value: 0.540395% CI: [0.62, 2.45]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With at Least 1 Continuous Atrial Tachycardia Episode (Defined as the Duration of the Longest Supraventricular Tachycardia [SVT] Run) ≥ 30 Seconds During the First 30 Days Post-surgery
At least one episode of continuous atrial tachycardia sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.
Time frame: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Population: All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With at Least 1 Continuous Atrial Tachycardia Episode (Defined as the Duration of the Longest Supraventricular Tachycardia [SVT] Run) ≥ 30 Seconds During the First 30 Days Post-surgery | 2.9 percentage of participants |
| AGN-151607 (125 U) | Percentage of Participants With at Least 1 Continuous Atrial Tachycardia Episode (Defined as the Duration of the Longest Supraventricular Tachycardia [SVT] Run) ≥ 30 Seconds During the First 30 Days Post-surgery | 11.5 percentage of participants |
| AGN-151607 (250 U) | Percentage of Participants With at Least 1 Continuous Atrial Tachycardia Episode (Defined as the Duration of the Longest Supraventricular Tachycardia [SVT] Run) ≥ 30 Seconds During the First 30 Days Post-surgery | 7.5 percentage of participants |
Comparison: P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).p-value: 0.016395% CI: [1.16, 13.42]Cochran-Mantel-Haenszel
Comparison: P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).p-value: 0.110195% CI: [0.76, 9.64]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With at Least 1 Continuous Episode of Either Atrial Fibrillation or Atrial Flutter or Atrial Tachycardia ≥ 30 Seconds During the First 30 Days Post-surgery
At least one episode of continuous atrial fibrillation or atrial flutter or atrial tachycardia sustained ≥ 30 seconds documented by monitoring ECG measurements using ECG patches (ePatch) placed on the participant's chest.
Time frame: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Population: All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With at Least 1 Continuous Episode of Either Atrial Fibrillation or Atrial Flutter or Atrial Tachycardia ≥ 30 Seconds During the First 30 Days Post-surgery | 48.0 percentage of participants |
| AGN-151607 (125 U) | Percentage of Participants With at Least 1 Continuous Episode of Either Atrial Fibrillation or Atrial Flutter or Atrial Tachycardia ≥ 30 Seconds During the First 30 Days Post-surgery | 41.3 percentage of participants |
| AGN-151607 (250 U) | Percentage of Participants With at Least 1 Continuous Episode of Either Atrial Fibrillation or Atrial Flutter or Atrial Tachycardia ≥ 30 Seconds During the First 30 Days Post-surgery | 51.9 percentage of participants |
Comparison: P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).p-value: 0.333995% CI: [0.64, 1.16]Cochran-Mantel-Haenszel
Comparison: P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).p-value: 0.461495% CI: [0.85, 1.42]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With at Least 1 Event of Symptomatic AF (Atrial Fibrillation or Atrial Flutter) During the First 30 Days Post-surgery
At least 1 event of symptomatic AF (atrial fibrillation or atrial flutter) (symptoms occurring within 2 hours of an AF episode). For symptomatic AF, symptoms that occur in the interval that starts two hours prior to the onset of the AF episode and ends two hours after the conclusion of the AF episode will meet the definition of within 2 hours of an AF episode. AF episode ≥ 30 seconds.
Time frame: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Population: All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With at Least 1 Event of Symptomatic AF (Atrial Fibrillation or Atrial Flutter) During the First 30 Days Post-surgery | 13.7 percentage of participants |
| AGN-151607 (125 U) | Percentage of Participants With at Least 1 Event of Symptomatic AF (Atrial Fibrillation or Atrial Flutter) During the First 30 Days Post-surgery | 13.5 percentage of participants |
| AGN-151607 (250 U) | Percentage of Participants With at Least 1 Event of Symptomatic AF (Atrial Fibrillation or Atrial Flutter) During the First 30 Days Post-surgery | 13.2 percentage of participants |
Comparison: P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).p-value: 0.981495% CI: [0.5, 1.96]Cochran-Mantel-Haenszel
Comparison: P-values and Risk Ratios (and their corresponding 95% CI) for each pairwise comparison of AGN-151607 versus Placebo are obtained from Cochran-Mantel-Haenszel (CMH) test controlling for type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years).p-value: 0.971595% CI: [0.5, 1.97]Cochran-Mantel-Haenszel
Secondary
Percentage of Time Spent in Atrial Fibrillation or Atrial Flutter (AF Burden) During the First 30 Days Post-surgery
The proportion of time an individual is in AF (atrial fibrillation or atrial flutter) during a monitoring period (expressed as a percentage) calculated as (the total time spent in AF during the first 30 days post-surgery divided by the total time of analyzable data obtained from the ECG patch during the first 30 days post-surgery) multiplied by 100. The calculation excludes continuous AF episodes \< 30 seconds in duration.
Time frame: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Population: All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percentage of Time Spent in Atrial Fibrillation or Atrial Flutter (AF Burden) During the First 30 Days Post-surgery | 4.84 percentage of time | Standard Deviation 14.898 |
| AGN-151607 (125 U) | Percentage of Time Spent in Atrial Fibrillation or Atrial Flutter (AF Burden) During the First 30 Days Post-surgery | 4.41 percentage of time | Standard Deviation 14.976 |
| AGN-151607 (250 U) | Percentage of Time Spent in Atrial Fibrillation or Atrial Flutter (AF Burden) During the First 30 Days Post-surgery | 5.45 percentage of time | Standard Deviation 15.821 |
Comparison: P-value is obtained from stratified Wilcoxon (Van Elteren) test versus Placebo with type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years) as stratification factors.p-value: 0.2972stratified Wilcoxon (Van Elteren)
Comparison: P-value is obtained from stratified Wilcoxon (Van Elteren) test versus Placebo with type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years) as stratification factors.p-value: 0.8722stratified Wilcoxon (Van Elteren)
Secondary
Time to First Occurrence of AF (Atrial Fibrillation or Atrial Flutter) During the First 30 Days Post-surgery
Amount of time (days) to first AF (atrial fibrillation or atrial flutter) occurrence defined by first episode of AF lasting for ≥ 30 seconds.
Time frame: First 30 days following the initial ICU admission date after open-chest cardiac surgery.
Population: All randomized participants who received study treatment and had at least 1 post-dose ECG (by ePatch) by Day 30 post-surgery.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to First Occurrence of AF (Atrial Fibrillation or Atrial Flutter) During the First 30 Days Post-surgery | NA Days |
| AGN-151607 (125 U) | Time to First Occurrence of AF (Atrial Fibrillation or Atrial Flutter) During the First 30 Days Post-surgery | NA Days |
| AGN-151607 (250 U) | Time to First Occurrence of AF (Atrial Fibrillation or Atrial Flutter) During the First 30 Days Post-surgery | NA Days |
Comparison: P-value is from stratified log-rank test versus Placebo with type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years) as stratification factors.p-value: 0.1281Log Rank
Comparison: P-value is from stratified log-rank test versus Placebo with type of surgery (presence or absence of valve surgery) and age group (\< 65 or ≥ 65 years) as stratification factors.p-value: 0.882Log Rank