Trial · NCT01776424
Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease
NCT01776424, Phase 3, Completed, Bayer; results first posted 2018-10-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease. Trials, record NCT01776424. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01776424
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease
- NCT number
- NCT01776424
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 27,395 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Prevention & Control
- Interventions
- Rivaroxaban (Xarelto, BAY59-7939), Rivaroxaban (Xarelto, BAY59-7939), Aspirin, Aspirin placebo, Rivaroxaban placebo, Pantoprazole, Pantoprazole placebo
- First posted
- 2013-01-28
- Last updated
- 2022-11-28
- Other registries' IDs
- eudract:2012-004180-43
- Results first posted
- 2018-10-05
- Limitations and caveats
- One participant that was included in the Safety Analysis Set in the disclosure after primary completion never took any study drug therefore was corrected in the later analysis.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death | For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days. | Count of participants and time from randomization to the first occurrence of the composite primary efficacy outcome, MI, stroke, or CV death were evaluated. Hazard ratios were calculated and reported as statistical analysis. |
| Primary | The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria | For each participant, the first occurrence of modified ISTH major bleeding after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days. | Modified ISTH major bleeding is defined as: i) Fatal bleeding, or ii) Symptomatic bleeding in a critical area or organ, such as intraarticular, intracranial, intramuscular with compartment syndrome, intraocular, intraspinal, liver, pancreas, pericardial, respiratory, retroperitoneal, adrenal gland or kidney; or bleeding into the surgical site requiring reoperation, or iii) Bleeding leading to hospitalization (major bleeding also includes presentation to an acute care facility with discharge on the same day). Count of participants and time from randomization to the first occurrence of the primary safety outcome major bleeding were evaluated. Hazard ratios were calculated and reported as statistical analysis. |
| Secondary | The First Occurrence of Myocardial Infarction (MI), Ischemic Stroke, Acute Limb Ischemia (ALI), or Coronary Heart Disease (CHD) Death | For each participant, the first occurrence of MI, ALI, or CHD death after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days. | Count of participants and time from randomization to the first occurrence of MI, ischemic stroke, ALI, or CHD death were evaluated. Hazard ratios were calculated and reported as statistical analysis. |
| Secondary | The First Occurrence of MI, Ischemic Stroke, ALI, or Cardiovascular (CV) Death | For each participant, the first occurrence of MI, ischemic stroke, ALI, or CV death after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days. | Count of participants and time from randomization to the first occurrence of MI, ischemic stroke, ALI, or CV death were evaluated. Hazard ratios were calculated and reported as statistical analysis. |
| Secondary | All-cause Mortality | For each participants, death by any cause after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days. | Count of participants and time from randomization to death by all cause were evaluated. Hazard ratios were calculated and reported as statistical analysis. |
| Other | The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death in LTOLE Part | For each participant, the first occurrence of the composite primary efficacy outcome after from COMPASS LTOLE initiation visit up until last LTOLE part contact date was considered. The mean time in follow-up was 428 days. | Count of participants from COMPASS LTOLE initiation visit to the first occurrence of the composite primary efficacy outcome, MI, stroke, or CV death were evaluated. LTOLE: long-term open-lable extension |
| Other | The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria in LTOLE Part | For each participant, the first occurrence of modified ISTH major bleeding from COMPASS LTOLE initiation visit up until 2 days after the last treatment in LTOLE part was considered. The mean time in follow-up was 421 days. | Modified ISTH major bleeding is defined as: i) Fatal bleeding, or ii) Symptomatic bleeding in a critical area or organ, such as intraarticular, intracranial, intramuscular with compartment syndrome, intraocular, intraspinal, liver, pancreas, pericardial, respiratory, retroperitoneal, adrenal gland or kidney; or bleeding into the surgical site requiring reoperation, or iii) Bleeding leading to hospitalization (major bleeding also includes presentation to an acute care facility with discharge on the same day). Count of participants from COMPASS LTOLE initiation visit to the first occurrence of the primary safety outcome major bleeding was evaluated. LTOLE: long-term open-lable extension |
| Other | All-cause Mortality in LTOLE Part | For each participants, death by any cause after COMPASS LTOLE initiation visit up until the the last LTOLE part contact date was considered. The mean time in follow-up until that date was 428 days. | Count of participants from COMPASS LTOLE initiation visit to death by all cause were evaluated. LTOLE: long-term open-lable extension |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death | For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days. | ITT: included all participants randomized to antithrombotic treatment for the initial study part. The ITT set comprised both participants randomized to pantoprazole/placebo and participants not randomized to pantoprazole/placebo. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria | For each participant, the first occurrence of modified ISTH major bleeding after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days. | ITT: included all participants randomized to antithrombotic treatment for the initial study part. The ITT set comprised both participants randomized to pantoprazole/placebo and participants not randomized to pantoprazole/placebo. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The First Occurrence of Myocardial Infarction (MI), Ischemic Stroke, Acute Limb Ischemia (ALI), or Coronary Heart Disease (CHD) Death | For each participant, the first occurrence of MI, ALI, or CHD death after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days. | ITT: included all participants randomized to antithrombotic treatment for the initial study part. The ITT set comprised both participants randomized to pantoprazole/placebo and participants not randomized to pantoprazole/placebo. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The First Occurrence of MI, Ischemic Stroke, ALI, or Cardiovascular (CV) Death | For each participant, the first occurrence of MI, ischemic stroke, ALI, or CV death after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days. | ITT: included all participants randomized to antithrombotic treatment for the initial study part. The ITT set comprised both participants randomized to pantoprazole/placebo and participants not randomized to pantoprazole/placebo. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | All-cause Mortality | For each participants, death by any cause after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days. | ITT: included all participants randomized to antithrombotic treatment for the initial study part. The ITT set comprised both participants randomized to pantoprazole/placebo and participants not randomized to pantoprazole/placebo. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death in LTOLE Part | For each participant, the first occurrence of the composite primary efficacy outcome after from COMPASS LTOLE initiation visit up until last LTOLE part contact date was considered. The mean time in follow-up was 428 days. | LTOLE ITT: included all participants who completed COMPASS LTOLE initiation visit (LTOLE initiation visit date entered). | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria in LTOLE Part | For each participant, the first occurrence of modified ISTH major bleeding from COMPASS LTOLE initiation visit up until 2 days after the last treatment in LTOLE part was considered. The mean time in follow-up was 421 days. | LTOLE SAF: included all participants who completed COMPASS LTOLE initiation visit and who received at least one dose of medication in LTOLE part. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | All-cause Mortality in LTOLE Part | For each participants, death by any cause after COMPASS LTOLE initiation visit up until the the last LTOLE part contact date was considered. The mean time in follow-up until that date was 428 days. | LTOLE ITT: included all participants who completed COMPASS LTOLE initiation visit (LTOLE initiation visit date entered). | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death | Rivaroxaban 2.5mg + Aspirin 100mg | 379 | Participants | ||
| The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death | Rivaroxaban 5mg + Aspirin Placebo | 448 | Participants | ||
| The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death | Rivaroxaban Placebo + Aspirin 100mg | 496 | Participants | ||
| The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria | Rivaroxaban 2.5mg + Aspirin 100mg | 288 | Participants | ||
| The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria | Rivaroxaban 5mg + Aspirin Placebo | 255 | Participants | ||
| The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria | Rivaroxaban Placebo + Aspirin 100mg | 170 | Participants | ||
| The First Occurrence of Myocardial Infarction (MI), Ischemic Stroke, Acute Limb Ischemia (ALI), or Coronary Heart Disease (CHD) Death | Rivaroxaban 2.5mg + Aspirin 100mg | 329 | Participants | ||
| The First Occurrence of Myocardial Infarction (MI), Ischemic Stroke, Acute Limb Ischemia (ALI), or Coronary Heart Disease (CHD) Death | Rivaroxaban 5mg + Aspirin Placebo | 397 | Participants | ||
| The First Occurrence of Myocardial Infarction (MI), Ischemic Stroke, Acute Limb Ischemia (ALI), or Coronary Heart Disease (CHD) Death | Rivaroxaban Placebo + Aspirin 100mg | 450 | Participants | ||
| The First Occurrence of MI, Ischemic Stroke, ALI, or Cardiovascular (CV) Death | Rivaroxaban 2.5mg + Aspirin 100mg | 389 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Antithrombotic Part (Double Blind) | STARTED | Rivaroxaban 2.5mg + Aspirin 100mg | 9,152 | |
| Antithrombotic Part (Double Blind) | STARTED | Rivaroxaban 5mg + Aspirin Placebo | 9,117 | |
| Antithrombotic Part (Double Blind) | STARTED | Rivaroxaban Placebo + Aspirin 100mg | 9,126 | |
| Antithrombotic Part (Double Blind) | Treated With Antithrombotic Treatment | Rivaroxaban 2.5mg + Aspirin 100mg | 9,134 | |
| Antithrombotic Part (Double Blind) | Treated With Antithrombotic Treatment | Rivaroxaban 5mg + Aspirin Placebo | 9,109 | |
| Antithrombotic Part (Double Blind) | Treated With Antithrombotic Treatment | Rivaroxaban Placebo + Aspirin 100mg | 9,107 | |
| Antithrombotic Part (Double Blind) | Randomized to Study Pantoprazole/Placebo | Rivaroxaban 2.5mg + Aspirin 100mg | 5,878 | |
| Antithrombotic Part (Double Blind) | Randomized to Study Pantoprazole/Placebo | Rivaroxaban 5mg + Aspirin Placebo | 5,859 | |
| Antithrombotic Part (Double Blind) | Randomized to Study Pantoprazole/Placebo | Rivaroxaban Placebo + Aspirin 100mg | 5,861 | |
| Antithrombotic Part (Double Blind) | COMPLETED | Rivaroxaban 2.5mg + Aspirin 100mg | 9,132 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events3,616
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 | Anaemia | Blood and lymphatic system disorders | Rivaroxaban 2.5mg + Aspirin 100mg | 14 | 9,134 | 24 |
| other | Anaemia | Blood and lymphatic system disorders | Rivaroxaban 5mg + Aspirin Placebo | 11 | 9,109 | 13 |
| other | Anaemia | Blood and lymphatic system disorders | Rivaroxaban Placebo + Aspirin 100mg | 9 | 9,107 | 11 |
| other | Anaemia | Blood and lymphatic system disorders | LTOLE Rivaroxaban Rivaroxaban 2.5mg + Aspirin 100mg | 4 | 12,903 | 6 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Rivaroxaban 2.5mg + Aspirin 100mg | 8 | 9,134 | 10 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Rivaroxaban 5mg + Aspirin Placebo | 12 | 9,109 | 16 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Rivaroxaban Placebo + Aspirin 100mg | 1 | 9,107 | 1 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | LTOLE Rivaroxaban Rivaroxaban 2.5mg + Aspirin 100mg | 0 | 12,903 | 0 |
| other | Atrial fibrillation | Cardiac disorders | Rivaroxaban 2.5mg + Aspirin 100mg | 24 | 9,134 | 41 |
| other | Atrial fibrillation | Cardiac disorders | Rivaroxaban 5mg + Aspirin Placebo | 18 | 9,109 | 32 |
1 to 10 of 3,616Source ClinicalTrials.gov
See all 3,616 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rivaroxaban 2.5mg + Aspirin 100mg | 529 | 9,152 |
| Total, all-cause mortality | Rivaroxaban 5mg + Aspirin Placebo | 566 | 9,117 |
| Total, all-cause mortality | Rivaroxaban Placebo + Aspirin 100mg | 566 | 9,126 |
| Total, all-cause mortality | LTOLE Rivaroxaban Rivaroxaban 2.5mg + Aspirin 100mg | 283 | 12,964 |
| Total, other adverse events | Rivaroxaban 2.5mg + Aspirin 100mg | 557 | 9,134 |
| Total, other adverse events | Rivaroxaban 5mg + Aspirin Placebo | 529 | 9,109 |
| Total, other adverse events | Rivaroxaban Placebo + Aspirin 100mg | 501 | 9,107 |
| Total, other adverse events | LTOLE Rivaroxaban Rivaroxaban 2.5mg + Aspirin 100mg | 49 | 12,903 |
| Total, serious adverse events | Rivaroxaban 2.5mg + Aspirin 100mg | 692 | 9,134 |
| Total, serious adverse events | Rivaroxaban 5mg + Aspirin Placebo | 664 | 9,109 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers66
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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