Heart; Dysfunction Postoperative, Cardiac Surgery
Conditions
Keywords
Suppress Atrial Fibrillation, heart bypass surgery, heart valve surgery
Brief summary
The objective of this study is to show that ranolazine is a safe, viable and potent alternative for post-operative atrial fibrillation suppression in patients undergoing cardiac surgery
Detailed description
A single center, double blind, prospective, randomized study for patients who are scheduled for elective cardiac surgery (Coronary Artery Bypass Graft \[CABG\], or valve or CABG and valve). All patients who meet criteria will be prospectively enrolled in a randomized fashion. Patients enrolled will be assigned to receive twice daily identical capsules containing either placebo or ranolazine. Study drug will be initiated 2 days before surgery. Patients will receive study drug throughout their hospitalization and be kept on it for a full 2 weeks post operatively. Patients will be seen in 2 weeks and receive a 30 day follow up contact visit.
Interventions
DRUGRanolazine
Ranolazine 1000mg (2-500mg tablets) twice daily. Starting 2 days prior to surgery, morning of surgery and up to 14 days post operative depending when the breathing tube is removed from the patient post operative. If intolerant to the study drug due to adverse effects or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500mg (1-500mg tablet) twice daily
DRUGPlacebo
Placebo 1000mg (2-500mg tablets) twice daily. Starting 2 days prior to surgery, morning of surgery and up to 14 days post operative depending when the breathing tube is removed from the patient post operative. If intolerant to the study drug due to adverse effects or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500mg (1-500mg tablet) twice daily
Sponsors
Beaumont Foundation of America
Gilead Sciences
Corewell Health East
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Indications for cardiac surgery (CABG, valve surgery or CABG and valve surgery, Able to provide informed consent.
Exclusion criteria
* Documented atrial fibrillation within the previous 3 months * Ongoing therapy with suppressive antiarrhythmic drugs * Patient currently on digoxin * Emergent surgery * Patient receiving hemodialysis * Concomitant use of ketoconazole, diltiazem, verapamil * Known tolerance or hypersensitivity to ranolazine * Pregnant individuals * MAZE procedure (is a surgical ablation to treat atrial fibrillation) performed during concurrent cardiac surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Any Episode of Post Operative Atrial Fibrillation Longer Than 6 Hours Duration Occurring During the Study Period. | The time between the completion of the operation and hospital discharge or 14 days post operative if the hospitalzation is prolonged | Freedom from any episode of post operative Atrial Fibrillation (AF) longer than 6 hours duration occurring during the study period. To document post operative atrial fibrillation. |
Countries
United States
Participant flow
Recruitment details
Recruitment started October 2010 and completed November 2012
Participants by arm
| Arm | Count |
|---|---|
| Ranolazine and Patients Having Heart Bypass Surgery 500 mg tab, 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.
Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses | 4 |
| Placebo Pill and Patients Having Heart Bypass Surgery 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.
Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses | 7 |
| Ranolazine and Patients Having Non Heart Bypass Surgery 500 mg tab, 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.
Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses | 2 |
| Placebo Pill and Patients Having Non Heart Bypass Surgery 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.
Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses | 2 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Physician Decision | 1 | 2 | 2 | 1 |
Baseline characteristics
| Characteristic | Placebo Pill and Patients Having Heart Bypass Surgery | Ranolazine and Patients Having Non Heart Bypass Surgery | Ranolazine and Patients Having Heart Bypass Surgery | Placebo Pill and Patients Having Non Heart Bypass Surgery | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 1 Participants | 3 Participants | 1 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 1 Participants | 1 Participants | 1 Participants | 7 Participants |
| Age, Continuous | 63.4 years STANDARD_DEVIATION 9.9 | 48.0 years STANDARD_DEVIATION 25.5 | 67.3 years STANDARD_DEVIATION 4.6 | 71.0 years STANDARD_DEVIATION 9.9 | 63.4 years STANDARD_DEVIATION 12.1 |
| Gender Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Gender Male | 7 Participants | 2 Participants | 4 Participants | 2 Participants | 15 Participants |
| Region of Enrollment United States | 7 participants | 2 participants | 4 participants | 2 participants | 15 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 4 | 0 / 7 | 0 / 2 | 0 / 2 |
| serious Total, serious adverse events | 0 / 4 | 0 / 7 | 0 / 2 | 0 / 2 |
Outcome results
Primary
Freedom From Any Episode of Post Operative Atrial Fibrillation Longer Than 6 Hours Duration Occurring During the Study Period.
Freedom from any episode of post operative Atrial Fibrillation (AF) longer than 6 hours duration occurring during the study period. To document post operative atrial fibrillation.
Time frame: The time between the completion of the operation and hospital discharge or 14 days post operative if the hospitalzation is prolonged
Population: Study was prematurely terminated. Data for this Outcome Measure were not collected