18 and older, any sex, with Prevention & Control. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) DeathPrimary· 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.
Group
Value
95% CI
Rivaroxaban 2.5mg + Aspirin 100mg
379
Rivaroxaban 5mg + Aspirin Placebo
448
Rivaroxaban Placebo + Aspirin 100mg
496
The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) CriteriaPrimary· 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 prim
Group
Value
95% CI
Rivaroxaban 2.5mg + Aspirin 100mg
288
Rivaroxaban 5mg + Aspirin Placebo
255
Rivaroxaban Placebo + Aspirin 100mg
170
The First Occurrence of Myocardial Infarction (MI), Ischemic Stroke, Acute Limb Ischemia (ALI), or Coronary Heart Disease (CHD) DeathSecondary· 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.
Group
Value
95% CI
Rivaroxaban 2.5mg + Aspirin 100mg
329
Rivaroxaban 5mg + Aspirin Placebo
397
Rivaroxaban Placebo + Aspirin 100mg
450
The First Occurrence of MI, Ischemic Stroke, ALI, or Cardiovascular (CV) DeathSecondary· 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.
Group
Value
95% CI
Rivaroxaban 2.5mg + Aspirin 100mg
389
Rivaroxaban 5mg + Aspirin Placebo
453
Rivaroxaban Placebo + Aspirin 100mg
516
All-cause MortalitySecondary· 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.
Group
Value
95% CI
Rivaroxaban 2.5mg + Aspirin 100mg
313
Rivaroxaban 5mg + Aspirin Placebo
366
Rivaroxaban Placebo + Aspirin 100mg
378
The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death in LTOLE PartSecondary· 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
Group
Value
95% CI
LTOLE Part: Rivaroxaban 2.5mg + Aspirin 100mg
353
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 PartSecondary· 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
Group
Value
95% CI
LTOLE Part: Rivaroxaban 2.5mg + Aspirin 100mg
138
All-cause Mortality in LTOLE PartSecondary· 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
Group
Value
95% CI
LTOLE Part: Rivaroxaban 2.5mg + Aspirin 100mg
282
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events (AEs) are reported: from randomization until 2 days after the last antithrombotic study treatment or until LTOLE part initiation visit (including a mean of 478 days in between) for randomized groups (2 years on average); OR from LTOLE initiation visit up until 2 days after the last treatment for LTOLE group (421 days on average). All-Cause Mortality encompasses all death cases until the last contact (2 years on average for randomized groups; 428 days on average for LTOLE group)..
Reporting threshold: 0.1%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05900388 — A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolis
· not yet recruiting
NCT06193863 — An Observational Study to Learn More About How Safe Rivaroxaban is And How Well it Works in Children With Congenital Hea
· active not recruiting
NCT05461807 — An Observational Study Called H2H-OSCAR-US to Learn More About How Well Rivaroxaban Works and How Safe it is Compared to
· completed
NCT05150938 — A Study to Gather Information About Rivaroxaban in Patients in Sweden With Cancer Who Also Have Thrombosis (OSCAR-SE)
· completed
NCT04923139 — A Study to Learn About Venous Thromboembolism (VTE) Treatment With Rivaroxaban in Japanese Patients Using a Claims Datab
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bayer
Last refreshed: 28 November 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01776424.