Trial · NCT01877915
A Study to Assess the Effectiveness and Safety of Rivaroxaban in Reducing the Risk of Death, Myocardial Infarction or Stroke in Participants With Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure
NCT01877915, Phase 3, Completed, Janssen Research & Development, LLC; results first posted 2019-05-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Assess the Effectiveness and Safety of Rivaroxaban in Reducing the Risk of Death, Myocardial Infarction or Stroke in Participants With Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure. Trials, record NCT01877915. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01877915
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study to Assess the Effectiveness and Safety of Rivaroxaban in Reducing the Risk of Death, Myocardial Infarction or Stroke in Participants With Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure
- NCT number
- NCT01877915
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 5,081 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Heart Failure, Coronary Artery Disease
- Interventions
- Rivaroxaban, Placebo, Standard of care for heart failure and coronary artery disease
- First posted
- 2013-06-14
- Last updated
- 2019-05-10
- Other registries' IDs
- eudract:2013-000046-19
- Results first posted
- 2019-05-10
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Event Rate of All-Cause Mortality, Myocardial Infarction (MI), or Stroke | Up to Global treatment end date (approximately 54 months) | 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. | Event rate per 100 patient-year | NUMBER |
| SECONDARY | Event Rate of Cardio Vascular Death or Re-Hospitalization for Worsening of Heart Failure (RHHF) | Up to Global treatment end date (approximately 54 months) | 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. | Event rate per 100 patient-year | NUMBER |
| SECONDARY | Event Rate of Cardio Vascular Death | Up to Global treatment end date (approximately 54 months) | 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. | Event rate per 100 patient-year | NUMBER |
| SECONDARY | Event Rate of Re-Hospitalization for Worsening of Heart Failure | Up to Global treatment end date (approximately 54 months) | 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. | Event rate per 100 patient-year | NUMBER |
| SECONDARY | Event Rate of Re-Hospitalization for Cardio Vascular Events (RHCV) | Up to Global treatment end date (approximately 54 months) | 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. | Event rate per 100 patient-year | NUMBER |
| SECONDARY | Event Rate of All-Cause Mortality (ACM) or Re-Hospitalization for Worsening Heart Failure | Up to Global treatment end date (approximately 54 months) | 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. | Event rate per 100 patient-year | NUMBER |
| PRIMARY | Event Rate of Either Fatal Bleeding or Bleeding Into a Critical Space With Potential for Permanent Disability | Up to 227 Weeks | 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. | Event rate per 100 patient-year | NUMBER |
| SECONDARY | Event Rate of Bleeding Events That Requiring Hospitalization | Up to 227 Weeks | 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. | Event rate per 100 patient-year | NUMBER |
| SECONDARY | Event Rate of International Society on Thrombosis and Haemostasis (ISTH) Major Bleeding Event | Up to 227 Weeks | 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. | Event rate per 100 patient-year | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Event Rate of All-Cause Mortality, Myocardial Infarction (MI), or Stroke | Rivaroxaban | 13.44 | Event rate per 100 patient-year | ||
| Event Rate of All-Cause Mortality, Myocardial Infarction (MI), or Stroke | Placebo | 14.27 | Event rate per 100 patient-year | ||
| Event Rate of Cardio Vascular Death or Re-Hospitalization for Worsening of Heart Failure (RHHF) | Rivaroxaban | 23.32 | Event rate per 100 patient-year | ||
| Event Rate of Cardio Vascular Death or Re-Hospitalization for Worsening of Heart Failure (RHHF) | Placebo | 23.46 | Event rate per 100 patient-year | ||
| Event Rate of Cardio Vascular Death | Rivaroxaban | 9.46 | Event rate per 100 patient-year | ||
| Event Rate of Cardio Vascular Death | Placebo | 9.96 | Event rate per 100 patient-year | ||
| Event Rate of Re-Hospitalization for Worsening of Heart Failure | Rivaroxaban | 17.24 | Event rate per 100 patient-year | ||
| Event Rate of Re-Hospitalization for Worsening of Heart Failure | Placebo | 17.45 | Event rate per 100 patient-year | ||
| Event Rate of Re-Hospitalization for Cardio Vascular Events (RHCV) | Rivaroxaban | 13.30 | Event rate per 100 patient-year | ||
| Event Rate of Re-Hospitalization for Cardio Vascular Events (RHCV) | Placebo | 14.04 | Event rate per 100 patient-year |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rivaroxaban | 2,507 | |
| Overall Study | STARTED | Placebo | 2,515 | |
| Overall Study | COMPLETED | Rivaroxaban | 2,453 | |
| Overall Study | COMPLETED | Placebo | 2,447 | |
| Overall Study | NOT COMPLETED | Rivaroxaban | 54 | |
| Overall Study | NOT COMPLETED | Placebo | 68 |
Source ClinicalTrials.gov
Adverse events1,048
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Rivaroxaban | 53 | 2,507 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 60 | 2,515 | |
| serious | Anaemia | Blood and lymphatic system disorders | Rivaroxaban | 12 | 2,507 | |
| serious | Anaemia | Blood and lymphatic system disorders | Placebo | 7 | 2,515 | |
| serious | Anaemia Vitamin B12 Deficiency | Blood and lymphatic system disorders | Rivaroxaban | 1 | 2,507 | |
| serious | Anaemia Vitamin B12 Deficiency | Blood and lymphatic system disorders | Placebo | 0 | 2,515 | |
| serious | Aplastic Anaemia | Blood and lymphatic system disorders | Rivaroxaban | 0 | 2,507 | |
| serious | Aplastic Anaemia | Blood and lymphatic system disorders | Placebo | 1 | 2,515 | |
| serious | Disseminated Intravascular Coagulation | Blood and lymphatic system disorders | Rivaroxaban | 0 | 2,507 | |
| serious | Disseminated Intravascular Coagulation | Blood and lymphatic system disorders | Placebo | 1 | 2,515 |
1 to 10 of 1,048Source ClinicalTrials.gov
See all 1,048 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rivaroxaban | 565 | 2,507 |
| Total, all-cause mortality | Placebo | 571 | 2,515 |
| Total, other adverse events | Rivaroxaban | 53 | 2,507 |
| Total, other adverse events | Placebo | 60 | 2,515 |
| Total, serious adverse events | Rivaroxaban | 479 | 2,507 |
| Total, serious adverse events | Placebo | 451 | 2,515 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Rivaroxaban vs Placebo: deaths from any cause | Trial comparisons |
| Rivaroxaban vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01877915
GET https://conductscience.org/api/trials/v1/NCT01877915/events?page=2