Coronary Artery Disease, Heart Failure
Conditions
Keywords
Heart Failure, Coronary Artery Disease, Stroke, Myocardial Infarction, Anticoagulation
Brief summary
The purpose of this study is to assess the effectiveness and safety of rivaroxaban compared with placebo (inactive medication), in reducing the risk of death, myocardial infarction or stroke in participants with heart failure and significant coronary artery disease following an episode of decompensated heart failure.
Detailed description
This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), parallel group (each participant group receives different treatments simultaneously), event driven (the study duration is determined by the time taken for a specific number of events to occur), multicenter study to assess the effectiveness and safety of rivaroxaban compared with placebo, in reducing the risk of death, myocardial infarction or stroke in participants with heart failure and significant coronary artery disease following an episode of decompensated heart failure. Participants will be randomly assigned in a 1:1 ratio to receive either rivaroxaban or placebo (each in addition to standard of care for heart failure and coronary artery disease as prescribed by their managing physician). The study will consist of a screening phase, a double-blind treatment phase, and a follow-up after the sponsor-announced global treatment end date (GTED, defined as the date when 1200 primary efficacy outcome events are predicted to have occurred). The double-blind treatment phase is estimated to last for 6 to 54 months. Participants will discontinue study drug after taking both their morning and evening doses on the GTED and will return to the study center for the end-of-study visit (between 15 and 45 days but no sooner than 15 days after the GTED). Patient safety will be monitored throughout the study. The average study duration for participants is expected to be approximately 29 months. The study drug, rivaroxaban, is approved in the United States and in multiple countries around the world for the prevention and treatment of a number of thrombosis-mediated conditions.
Interventions
DRUGRivaroxaban
Each participant, randomly allocated to the rivaroxaban arm, will receive one 2.5 mg tablet of rivaroxaban orally (by mouth) twice daily (once in the morning and once in the evening at approximately the same time each day) until the global treatment end date (GTED) (defined as the date when 1200 primary efficacy outcome events have occurred). Rivaroxaban will be given with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
DRUGPlacebo
Each participant, randomly allocated to the placebo arm, will receive one matching placebo tablet orally twice daily (once in the morning and once in the evening at approximately the same time each day) until the GTED. Placebo will be given with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
OTHERStandard of care for heart failure and coronary artery disease
Each participant's standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician) should be continued throughout the study.
Sponsors
Bayer
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* Must have symptomatic heart failure for at least 3 months prior to Screening * Participants must have an episode of decompensated heart failure (index event) requiring (a) an overnight stay \[that is, staying past midnight\] in a hospital, emergency department, or medical facility with the capability of treating with intravenous medications and observing heart failure patients before randomization or (b) an unscheduled outpatient visit to a heart failure management center, where parenteral therapy is required for heart failure stabilization. An episode of decompensated heart failure is defined as symptoms of worsening dyspnea or fatigue, objective signs of congestion such as peripheral edema or ascites, and/or adjustment of pre-hospitalization/outpatient visit heart failure medications. Participants are eligible for randomization at discharge from the facility treating the index event and up to 30 days after discharge if they are in stable condition * Must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40 percent (%) within 1 year before randomization * Must have evidence of significant coronary artery disease * Must be medically stable in terms of their heart failure clinical status at the time of randomization * Must have a brain natriuretic peptide (BNP) level greater than or equal to (\>=) 200 picogram per milliliter (pg/mL) or N-terminal-proBNP (NT-proBNP) level \>=800 pg/mL (preferred assay) during the Screening period and before randomization
Exclusion criteria
* Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding, such as, but not limited to, active internal bleeding, clinically significant bleeding, bleeding at a noncompressible site, or bleeding diathesis within 28 days of randomization * Severe concomitant disease such as (a) atrial fibrillation (AFib) or another condition that requires chronic anticoagulation (participants with isolated transient AFib may be allowed at the discretion of the treating physician investigator) and (b) Documented acute myocardial infarction (MI) during index event * Prior stroke within 90 days of randomization * Has been hospitalized for longer than 21 days during the index event * Planned intermittent outpatient treatment with positive inotropic drugs administered intravenously
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Event Rate of All-Cause Mortality, Myocardial Infarction (MI), or Stroke | Up to Global treatment end date (approximately 54 months) | Event Rate of all-cause mortality (ACM), MI, or stroke were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 patient \[pt\]-year \[yr\]) = 100\*n/(total risk exposure), where n is the number of events. |
| Event Rate of Either Fatal Bleeding or Bleeding Into a Critical Space With Potential for Permanent Disability | Up to 227 Weeks | Event rate of either fatal bleeding or bleeding into critical space with potential for permanent disability were assessed. Fatal bleeding event was death within 7 days after a bleeding event which required hospitalization or met International Society on Thrombosis and Haemostasis(ISTH) major bleeding definition criteria. Fatal bleeding events included those met criteria in 3 categories: 1: Any ISTH major bleeding event consider primary cause of death by investigator; 2: Any ISTH major bleeding event not considered to be primary cause of death by investigator but resulted in death within 7 days;3: Any bleeding event resulted in hospital stay and death within 7 days. Bleeding into critical space with potential for permanent disability included 7 critical spaces: intracranial, intraspinal, intraocular. Event rate estimated based on time to first occurrence of event were reported in the study. Event Rate / (100 pt-yr) = 100\*n/(total risk exposure), where n is the number of events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Event Rate of Re-Hospitalization for Worsening of Heart Failure | Up to Global treatment end date (approximately 54 months) | Event rate of re-hospitalization for worsening of heart failure were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100\*n/(total risk exposure), where n is the number of events. |
| Event Rate of Re-Hospitalization for Cardio Vascular Events (RHCV) | Up to Global treatment end date (approximately 54 months) | Event rate due to cardio vascular events were assessed. Hospitalization for a CV Event required that participants be hospitalized (in-patient or emergency department) for greater than 24 hours and must have met the following criterion:Discharge summary with primary reason for admission listed as CV in nature (example, bleeding, arrhythmia, ACS, MI) other than HF which was captured in the HF re-hospitalization. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100\*n/(total risk exposure), where n is the number of events. |
| Event Rate of Cardio Vascular Death or Re-Hospitalization for Worsening of Heart Failure (RHHF) | Up to Global treatment end date (approximately 54 months) | Event rate of cardio vascular (CV) death or re-hospitalization for worsening of heart failure were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100\*n/(total risk exposure), where n is the number of events. |
| Event Rate of Bleeding Events That Requiring Hospitalization | Up to 227 Weeks | Event rate of bleeding events and required Hospitalization were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100\*n/(total risk exposure), where n is the number of events. |
| Event Rate of International Society on Thrombosis and Haemostasis (ISTH) Major Bleeding Event | Up to 227 Weeks | Event rate of ISTH major bleeding event were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100\*n/(total risk exposure), where n is the number of events. |
| Event Rate of All-Cause Mortality (ACM) or Re-Hospitalization for Worsening Heart Failure | Up to Global treatment end date (approximately 54 months) | Event rate of all-Cause Mortality (ACM) or re-Hospitalization for worsening heart failure were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100\*n/(total risk exposure), where n is the number of events. |
| Event Rate of Cardio Vascular Death | Up to Global treatment end date (approximately 54 months) | Event rate of cardio vascular death were assessed. CV death included deaths due to spontaneous bleeding, MI, stroke, worsening HF and arrhythmias, death due to CV procedures and sudden death. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100\*n/(total risk exposure), where n is the number of events. |
Countries
Argentina, Australia, Brazil, Bulgaria, Canada, China, Czechia, Denmark, Estonia, France, Germany, Greece, Hungary, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Poland, Portugal, Romania, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Turkey (Türkiye), Ukraine, United Kingdom, United States
Participant flow
Pre-assignment details
A total of 3 participants randomized twice were only counted once in the ITT analysis set (comprised of 5,022 participants).
Participants by arm
| Arm | Count |
|---|---|
| Rivaroxaban Participants received 2.5 milligram (mg) tablet of rivaroxaban orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician). | 2,507 |
| Placebo Participants received matching placebo orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician). | 2,515 |
| Total | 5,022 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 10 | 9 |
| Overall Study | Other | 2 | 4 |
| Overall Study | Withdrawal by Subject | 42 | 55 |
Baseline characteristics
| Characteristic | Rivaroxaban | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 66.5 years STANDARD_DEVIATION 10.07 | 66.4 years STANDARD_DEVIATION 10.17 | 66.3 years STANDARD_DEVIATION 10.27 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 309 Participants | 609 Participants | 300 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2186 Participants | 4389 Participants | 2203 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 12 Participants | 24 Participants | 12 Participants |
| Race/Ethnicity, Customized Asian | 362 Participants | 727 Participants | 365 Participants |
| Race/Ethnicity, Customized Black or African American | 29 Participants | 65 Participants | 36 Participants |
| Race/Ethnicity, Customized Other | 59 Participants | 115 Participants | 56 Participants |
| Race/Ethnicity, Customized White Hispanic or Latino | 258 Participants | 509 Participants | 251 Participants |
| Race/Ethnicity, Customized White Non-Hispanic | 1799 Participants | 3606 Participants | 1807 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 11 Participants | 21 Participants | 10 Participants |
| Race (NIH/OMB) Asian | 362 Participants | 727 Participants | 365 Participants |
| Race (NIH/OMB) Black or African American | 29 Participants | 65 Participants | 36 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 9 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 36 Participants | 70 Participants | 34 Participants |
| Race (NIH/OMB) White | 2063 Participants | 4128 Participants | 2065 Participants |
| Region of Enrollment ARGENTINA | 76 Participants | 152 Participants | 76 Participants |
| Region of Enrollment AUSTRALIA | 7 Participants | 14 Participants | 7 Participants |
| Region of Enrollment BRAZIL | 80 Participants | 160 Participants | 80 Participants |
| Region of Enrollment BULGARIA | 314 Participants | 628 Participants | 314 Participants |
| Region of Enrollment CANADA | 14 Participants | 28 Participants | 14 Participants |
| Region of Enrollment CHINA | 186 Participants | 372 Participants | 186 Participants |
| Region of Enrollment CZECH REPUBLIC | 35 Participants | 69 Participants | 34 Participants |
| Region of Enrollment DENMARK | 9 Participants | 18 Participants | 9 Participants |
| Region of Enrollment FRANCE | 10 Participants | 20 Participants | 10 Participants |
| Region of Enrollment GERMANY | 32 Participants | 64 Participants | 32 Participants |
| Region of Enrollment GREECE | 8 Participants | 16 Participants | 8 Participants |
| Region of Enrollment HUNGARY | 69 Participants | 138 Participants | 69 Participants |
| Region of Enrollment ITALY | 35 Participants | 71 Participants | 36 Participants |
| Region of Enrollment JAPAN | 133 Participants | 265 Participants | 132 Participants |
| Region of Enrollment LATVIA | 12 Participants | 25 Participants | 13 Participants |
| Region of Enrollment LITHUANIA | 17 Participants | 35 Participants | 18 Participants |
| Region of Enrollment MALAYSIA | 17 Participants | 34 Participants | 17 Participants |
| Region of Enrollment MEXICO | 73 Participants | 146 Participants | 73 Participants |
| Region of Enrollment NETHERLANDS | 1 Participants | 3 Participants | 2 Participants |
| Region of Enrollment POLAND | 288 Participants | 578 Participants | 290 Participants |
| Region of Enrollment PORTUGAL | 20 Participants | 42 Participants | 22 Participants |
| Region of Enrollment ROMANIA | 200 Participants | 398 Participants | 198 Participants |
| Region of Enrollment RUSSIAN FEDERATION | 274 Participants | 550 Participants | 276 Participants |
| Region of Enrollment SLOVAKIA | 41 Participants | 82 Participants | 41 Participants |
| Region of Enrollment SOUTH AFRICA | 8 Participants | 16 Participants | 8 Participants |
| Region of Enrollment SOUTH KOREA | 24 Participants | 48 Participants | 24 Participants |
| Region of Enrollment SPAIN | 89 Participants | 178 Participants | 89 Participants |
| Region of Enrollment SWEDEN | 2 Participants | 5 Participants | 3 Participants |
| Region of Enrollment TURKEY | 96 Participants | 192 Participants | 96 Participants |
| Region of Enrollment UKRAINE | 264 Participants | 529 Participants | 265 Participants |
| Region of Enrollment UNITED KINGDOM | 13 Participants | 25 Participants | 12 Participants |
| Region of Enrollment UNITED STATES | 60 Participants | 121 Participants | 61 Participants |
| Sex: Female, Male Female | 551 Participants | 1150 Participants | 599 Participants |
| Sex: Female, Male Male | 1956 Participants | 3872 Participants | 1916 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 565 / 2,507 | 571 / 2,515 |
| other Total, other adverse events | 53 / 2,507 | 60 / 2,515 |
| serious Total, serious adverse events | 479 / 2,507 | 451 / 2,515 |
Outcome results
Primary
Event Rate of All-Cause Mortality, Myocardial Infarction (MI), or Stroke
Event Rate of all-cause mortality (ACM), MI, or stroke were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 patient \[pt\]-year \[yr\]) = 100\*n/(total risk exposure), where n is the number of events.
Time frame: Up to Global treatment end date (approximately 54 months)
Population: Intent-to-Treat analysis set included all randomized unique participants who signed a valid informed consent. Participants were analyzed according to the treatment group assigned, irrespective of the actual treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rivaroxaban | Event Rate of All-Cause Mortality, Myocardial Infarction (MI), or Stroke | 13.44 Event rate per 100 patient-year |
| Placebo | Event Rate of All-Cause Mortality, Myocardial Infarction (MI), or Stroke | 14.27 Event rate per 100 patient-year |
Comparison: Statistical Analysis 1p-value: 0.2795% CI: [0.84, 1.05]Log Rank
Primary
Event Rate of Either Fatal Bleeding or Bleeding Into a Critical Space With Potential for Permanent Disability
Event rate of either fatal bleeding or bleeding into critical space with potential for permanent disability were assessed. Fatal bleeding event was death within 7 days after a bleeding event which required hospitalization or met International Society on Thrombosis and Haemostasis(ISTH) major bleeding definition criteria. Fatal bleeding events included those met criteria in 3 categories: 1: Any ISTH major bleeding event consider primary cause of death by investigator; 2: Any ISTH major bleeding event not considered to be primary cause of death by investigator but resulted in death within 7 days;3: Any bleeding event resulted in hospital stay and death within 7 days. Bleeding into critical space with potential for permanent disability included 7 critical spaces: intracranial, intraspinal, intraocular. Event rate estimated based on time to first occurrence of event were reported in the study. Event Rate / (100 pt-yr) = 100\*n/(total risk exposure), where n is the number of events.
Time frame: Up to 227 Weeks
Population: Safety Analysis Set included all intent-to-treat participants who received at least one dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rivaroxaban | Event Rate of Either Fatal Bleeding or Bleeding Into a Critical Space With Potential for Permanent Disability | Fatal Bleeding | 0.22 Event rate per 100 patient-year |
| Rivaroxaban | Event Rate of Either Fatal Bleeding or Bleeding Into a Critical Space With Potential for Permanent Disability | Critical Space Bleeding with Permanent Disability | 0.32 Event rate per 100 patient-year |
| Placebo | Event Rate of Either Fatal Bleeding or Bleeding Into a Critical Space With Potential for Permanent Disability | Fatal Bleeding | 0.22 Event rate per 100 patient-year |
| Placebo | Event Rate of Either Fatal Bleeding or Bleeding Into a Critical Space With Potential for Permanent Disability | Critical Space Bleeding with Permanent Disability | 0.48 Event rate per 100 patient-year |
Comparison: Statistical Analysis 1 (Fatal Bleeding)p-value: 0.95195% CI: [0.41, 2.59]Log Rank
Comparison: Statistical Analysis 2 (Bleeding in Critical Space with Potential for Permanent Disability)p-value: 0.25395% CI: [0.33, 1.34]Log Rank
Secondary
Event Rate of All-Cause Mortality (ACM) or Re-Hospitalization for Worsening Heart Failure
Event rate of all-Cause Mortality (ACM) or re-Hospitalization for worsening heart failure were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100\*n/(total risk exposure), where n is the number of events.
Time frame: Up to Global treatment end date (approximately 54 months)
Population: Intent-to-Treat analysis set included all randomized unique participants who signed a valid informed consent. Participants were analyzed according to the treatment group assigned, irrespective of the actual treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rivaroxaban | Event Rate of All-Cause Mortality (ACM) or Re-Hospitalization for Worsening Heart Failure | 24.84 Event rate per 100 patient-year |
| Placebo | Event Rate of All-Cause Mortality (ACM) or Re-Hospitalization for Worsening Heart Failure | 24.57 Event rate per 100 patient-year |
Secondary
Event Rate of Bleeding Events That Requiring Hospitalization
Event rate of bleeding events and required Hospitalization were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100\*n/(total risk exposure), where n is the number of events.
Time frame: Up to 227 Weeks
Population: Safety Analysis Set included all intent-to-treat participants who received at least one dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rivaroxaban | Event Rate of Bleeding Events That Requiring Hospitalization | 1.52 Event rate per 100 patient-year |
| Placebo | Event Rate of Bleeding Events That Requiring Hospitalization | 1.16 Event rate per 100 patient-year |
Secondary
Event Rate of Cardio Vascular Death
Event rate of cardio vascular death were assessed. CV death included deaths due to spontaneous bleeding, MI, stroke, worsening HF and arrhythmias, death due to CV procedures and sudden death. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100\*n/(total risk exposure), where n is the number of events.
Time frame: Up to Global treatment end date (approximately 54 months)
Population: Intent-to-Treat analysis set included all randomized unique participants who signed a valid informed consent. Participants were analyzed according to the treatment group assigned, irrespective of the actual treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rivaroxaban | Event Rate of Cardio Vascular Death | 9.46 Event rate per 100 patient-year |
| Placebo | Event Rate of Cardio Vascular Death | 9.96 Event rate per 100 patient-year |
Secondary
Event Rate of Cardio Vascular Death or Re-Hospitalization for Worsening of Heart Failure (RHHF)
Event rate of cardio vascular (CV) death or re-hospitalization for worsening of heart failure were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100\*n/(total risk exposure), where n is the number of events.
Time frame: Up to Global treatment end date (approximately 54 months)
Population: Intent-to-Treat analysis set included all randomized unique participants who signed a valid informed consent. Participants were analyzed according to the treatment group assigned, irrespective of the actual treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rivaroxaban | Event Rate of Cardio Vascular Death or Re-Hospitalization for Worsening of Heart Failure (RHHF) | 23.32 Event rate per 100 patient-year |
| Placebo | Event Rate of Cardio Vascular Death or Re-Hospitalization for Worsening of Heart Failure (RHHF) | 23.46 Event rate per 100 patient-year |
Secondary
Event Rate of International Society on Thrombosis and Haemostasis (ISTH) Major Bleeding Event
Event rate of ISTH major bleeding event were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100\*n/(total risk exposure), where n is the number of events.
Time frame: Up to 227 Weeks
Population: Safety Analysis Set included all intent-to-treat participants who received at least one dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rivaroxaban | Event Rate of International Society on Thrombosis and Haemostasis (ISTH) Major Bleeding Event | 2.04 Event rate per 100 patient-year |
| Placebo | Event Rate of International Society on Thrombosis and Haemostasis (ISTH) Major Bleeding Event | 1.21 Event rate per 100 patient-year |
Secondary
Event Rate of Re-Hospitalization for Cardio Vascular Events (RHCV)
Event rate due to cardio vascular events were assessed. Hospitalization for a CV Event required that participants be hospitalized (in-patient or emergency department) for greater than 24 hours and must have met the following criterion:Discharge summary with primary reason for admission listed as CV in nature (example, bleeding, arrhythmia, ACS, MI) other than HF which was captured in the HF re-hospitalization. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100\*n/(total risk exposure), where n is the number of events.
Time frame: Up to Global treatment end date (approximately 54 months)
Population: Intent-to-Treat analysis set included all randomized unique participants who signed a valid informed consent. Participants were analyzed according to the treatment group assigned, irrespective of the actual treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rivaroxaban | Event Rate of Re-Hospitalization for Cardio Vascular Events (RHCV) | 13.30 Event rate per 100 patient-year |
| Placebo | Event Rate of Re-Hospitalization for Cardio Vascular Events (RHCV) | 14.04 Event rate per 100 patient-year |
Secondary
Event Rate of Re-Hospitalization for Worsening of Heart Failure
Event rate of re-hospitalization for worsening of heart failure were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100\*n/(total risk exposure), where n is the number of events.
Time frame: Up to Global treatment end date (approximately 54 months)
Population: Intent-to-Treat analysis set included all randomized unique participants who signed a valid informed consent. Participants were analyzed according to the treatment group assigned, irrespective of the actual treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rivaroxaban | Event Rate of Re-Hospitalization for Worsening of Heart Failure | 17.24 Event rate per 100 patient-year |
| Placebo | Event Rate of Re-Hospitalization for Worsening of Heart Failure | 17.45 Event rate per 100 patient-year |