Completed
PHASE3
INTERVENTIONAL
NCT01776424
Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
The primary objectives of this study are: * To determine whether rivaroxaban 2.5 mg twice daily (bid) + aspirin 100 mg once daily (od) compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke, or cardiovascular death in subjects with coronary artery disease (CAD) or peripheral artery disease (PAD); * To determine whether rivaroxaban 5 mg bid compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke or cardiovascular death in subjects with CAD or PAD.
Interventions
Name:
Rivaroxaban (Xarelto, BAY59-7939)
Type:
DRUG
Description:
Tablet, 2.5 mg, twice daily, oral
Name:
Rivaroxaban (Xarelto, BAY59-7939)
Type:
DRUG
Description:
Tablet, 5 mg, twice daily, oral
Name:
Aspirin
Type:
DRUG
Description:
Tablet, 100 mg, once daily, oral
Name:
Aspirin placebo
Type:
DRUG
Description:
Aspirin matching placebo, once daily, oral
Name:
Rivaroxaban placebo
Type:
DRUG
Description:
Rivaroxaban matching placebo, twice daily, oral
Name:
Pantoprazole
Type:
DRUG
Description:
Tablet, 40 mg, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole
Name:
Pantoprazole placebo
Type:
DRUG
Description:
Pantoprazole matching placebo, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole placebo
Primary Outcomes
Measure:
The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death
TimeFrame:
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.
Description:
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.
Measure:
The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria
TimeFrame:
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.
Description:
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.
Trial Information
NCT ID
NCT01776424
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Bayer
Last Updated
December 15, 2025