---
title: Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease
nct_id: NCT01776424
overall_status: COMPLETED
phase: PHASE3
sponsor: Bayer
study_type: INTERVENTIONAL
primary_condition: Prevention & Control
countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, Denmark, Ecuador, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, Philippines, Poland, Romania, Russia, Slovakia, South Africa, South Korea, Sweden, Switzerland, Ukraine, United Kingdom
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01776424.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01776424"
ct_last_update_post_date: 2022-11-28
last_seen_at: "2026-05-12T06:11:53.227Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease

**Official Title:** A Randomized Controlled Trial of Rivaroxaban for the Prevention of Major Cardiovascular Events in Patients With Coronary or Peripheral Artery Disease (COMPASS - Cardiovascular OutcoMes for People Using Anticoagulation StrategieS).

**NCT ID:** [NCT01776424](https://clinicaltrials.gov/study/NCT01776424)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 27395
- **Lead Sponsor:** Bayer
- **Collaborators:** Population Health Research Institute, Janssen Research & Development, LLC
- **Conditions:** Prevention & Control
- **Start Date:** 2013-02-28
- **Completion Date:** 2021-06-15
- **CT.gov Last Update:** 2022-11-28

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

\- Meet criteria for CAD and/or PAD

Subjects with CAD must also meet at least one of the following criteria:

* Age ≥65, or
* Age \<65 and documented atherosclerosis or revascularization involving at least 2 vascular beds, or at least 2 additional risk factors

Exclusion Criteria:

* Stroke within 1 month or any history of hemorrhagic or lacunar stroke
* Severe heart failure with known ejection fraction \<30% or New York Heart Association (NYHA) class III or IV symptoms
* Estimated glomerular filtration rate (eGFR)\<15 mL/min
* Need for dual antiplatelet therapy, other non-aspirin antiplatelet therapy, or oral anticoagulant therapy
```

## Arms

- **Rivaroxaban 2.5mg + Aspirin 100mg** (EXPERIMENTAL) — Participants received rivaroxaban 2.5 mg twice daily (bid) and aspirin 100 mg once daily (od). All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a proton pump inhibitor (PPI), were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. Participants who consented to LTOLE part received open label rivaroxaban 2.5 mg bid and aspirin 100 mg od in LTOLE part.
- **Rivaroxaban 5mg + Aspirin Placebo** (EXPERIMENTAL) — Participants received rivaroxaban 5 mg bid and aspirin placebo od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. Participants who consented to LTOLE part received open label rivaroxaban 2.5 mg bid and aspirin 100 mg od in LTOLE part.
- **Rivaroxaban Placebo + Aspirin 100mg** (ACTIVE_COMPARATOR) — Participants received rivaroxaban placebo bid and aspirin 100 mg od. All doses were provided in tablet form for oral administration. Participants who did not have a continuous need to take a PPI, were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. Participants who consented to LTOLE part received open label rivaroxaban 2.5 mg bid and aspirin 100 mg od in LTOLE part.

## Interventions

- **Rivaroxaban (Xarelto, BAY59-7939)** (DRUG) — Tablet, 2.5 mg, twice daily, oral
- **Rivaroxaban (Xarelto, BAY59-7939)** (DRUG) — Tablet, 5 mg, twice daily, oral
- **Aspirin** (DRUG) — Tablet, 100 mg, once daily, oral
- **Aspirin placebo** (DRUG) — Aspirin matching placebo, once daily, oral
- **Rivaroxaban placebo** (DRUG) — Rivaroxaban matching placebo, twice daily, oral
- **Pantoprazole** (DRUG) — Tablet, 40 mg, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole
- **Pantoprazole placebo** (DRUG) — Pantoprazole matching placebo, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole placebo

## Primary Outcomes

- **The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death** _(time frame: 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.
- **The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria** _(time frame: 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 Outcomes

- **The First Occurrence of Myocardial Infarction (MI), Ischemic Stroke, Acute Limb Ischemia (ALI), or Coronary Heart Disease (CHD) Death** _(time frame: 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.)_
- **The First Occurrence of MI, Ischemic Stroke, ALI, or Cardiovascular (CV) Death** _(time frame: 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.)_
- **All-cause Mortality** _(time frame: 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.)_

## Locations (565)

- Birmingham, Alabama, United States
- Mobile, Alabama, United States
- Anaheim, California, United States
- Laguna Hills, California, United States
- Northridge, California, United States
- Palo Alto, California, United States
- Santa Rosa, California, United States
- Sylmar, California, United States
- Torrance, California, United States
- Norwalk, Connecticut, United States
- Stamford, Connecticut, United States
- Trumbull, Connecticut, United States
- Atlantis, Florida, United States
- Clearwater, Florida, United States
- Coral Springs, Florida, United States
- Jacksonville Beach, Florida, United States
- Largo, Florida, United States
- New Port Richey, Florida, United States
- Safety Harbor, Florida, United States
- Sarasota, Florida, United States
- Meridian, Idaho, United States
- Arlington Heights, Illinois, United States
- Hazel Crest, Illinois, United States
- Davenport, Iowa, United States
- West Des Moines, Iowa, United States
- Crestview Hills, Kentucky, United States
- Baltimore, Maryland, United States
- Haverhill, Massachusetts, United States
- Alpena, Michigan, United States
- Jackson, Michigan, United States
- St Louis, Missouri, United States
- Kalispell, Montana, United States
- New Brunswick, New Jersey, United States
- Cortlandt Manor, New York, United States
- Kingston, New York, United States
- Saratoga Springs, New York, United States
- Durham, North Carolina, United States
- Pinehurst, North Carolina, United States
- Elyria, Ohio, United States
- Sandusky, Ohio, United States
- Toledo, Ohio, United States
- Doylestown, Pennsylvania, United States
- Langhorne, Pennsylvania, United States
- Yardley, Pennsylvania, United States
- Sioux Falls, South Dakota, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Bellevue, Washington, United States
- Puyallup, Washington, United States
- Seattle, Washington, United States
- Spokane, Washington, United States
- Adrogué, Buenos Aires, Argentina
- Bahía Blanca, Buenos Aires, Argentina
- Coronel Suárez, Buenos Aires, Argentina
- Junín, Buenos Aires, Argentina
- La Plata, Buenos Aires, Argentina
- La Plata, Buenos Aires, Argentina
- La Plata, Buenos Aires, Argentina
- La Plata, Buenos Aires, Argentina
- Mar del Plata, Buenos Aires, Argentina
- Merlo, Buenos Aires, Argentina
- Munro, Buenos Aires, Argentina
- Quilmes, Buenos Aires, Argentina
- Ramos Mejía, Buenos Aires, Argentina
- San Martín, Buenos Aires, Argentina
- San Nicolás de los Arroyos, Buenos Aires, Argentina
- Vicente López, Buenos Aires, Argentina
- Zárate, Buenos Aires, Argentina
- Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
- Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
- Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
- Ciudad Autón. de Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
- Villa Allende, Córdoba Province, Argentina
- Villa María, Córdoba Province, Argentina
- Santa Rosa, La Pampa Province, Argentina
- Rafaela, Santa Fe Province, Argentina
- Rosario, Santa Fe Province, Argentina
- Rosario, Santa Fe Province, Argentina
- Rosario, Santa Fe Province, Argentina
- Venado Tuerto, Santa Fe Province, Argentina
- San Miguel de Tucumán, Tucumán Province, Argentina
- San Miguel de Tucumán, Tucumán Province, Argentina
- Ciudad Auton. de Buenos Aires, Argentina
- Ciudad Auton. de Buenos Aires, Argentina
- Ciudad Auton. de Buenos Aires, Argentina
- Corrientes, Argentina
- Córdoba, Argentina
- Córdoba, Argentina
- Córdoba, Argentina
- Córdoba, Argentina
- Córdoba, Argentina
- Córdoba, Argentina
- Salta, Argentina
- San Juan, Argentina
- San Luis, Argentina
- Santa Fe, Argentina
- Bruce, Australian Capital Territory, Australia
- Gosford, New South Wales, Australia
- New Lambton Heights, New South Wales, Australia
- Taree, New South Wales, Australia
- Birtinya, Queensland, Australia
- Brisbane, Queensland, Australia
- Brisbane, Queensland, Australia
- Redcliffe, Queensland, Australia
- Woolloongabba, Queensland, Australia
- Adelaide, South Australia, Australia
- Hobart, Tasmania, Australia
- Launceston, Tasmania, Australia
- Geelong, Victoria, Australia
- Melbourne, Victoria, Australia
- Melbourne, Victoria, Australia
- Prahran, Victoria, Australia
- Murdoch, Western Australia, Australia
- Nedlands, Western Australia, Australia
- Antwerp, Belgium
- Bonheiden, Belgium
- Bruges, Belgium
- Bruxelles - Brussel, Belgium
- Charleroi, Belgium
- Genk, Belgium
- Hasselt, Belgium
- Kortrijk, Belgium
- Leuven, Belgium
- Liège, Belgium
- Roeselare, Belgium
- Goiânia, Goiás, Brazil
- Belo Horizonte, Minas Gerais, Brazil
- Uberaba, Minas Gerais, Brazil
- Uberlândia, Minas Gerais, Brazil
- Campina Grande do Sul, Paraná, Brazil
- Curitiba, Paraná, Brazil
- Canoas, Rio Grande do Sul, Brazil
- Pelotas, Rio Grande do Sul, Brazil
- Porto Alegre, Rio Grande do Sul, Brazil
- Porto Alegre, Rio Grande do Sul, Brazil
- Porto Alegre, Rio Grande do Sul, Brazil
- Porto Alegre, Rio Grande do Sul, Brazil
- Blumenau, Santa Catarina, Brazil
- Campinas, São Paulo, Brazil
- Campinas, São Paulo, Brazil
- Campinas, São Paulo, Brazil
- Matão, São Paulo, Brazil
- São José do Rio Preto, São Paulo, Brazil
- São José do Rio Preto, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
- Votuporanga, São Paulo, Brazil
- São Paulo, Brazil
- Calgary, Alberta, Canada
- Edmonton, Alberta, Canada
- New Westminster, British Columbia, Canada
- Victoria, British Columbia, Canada
- Winnipeg, Manitoba, Canada
- Winnipeg, Manitoba, Canada
- Winnipeg, Manitoba, Canada
- Winnipeg, Manitoba, Canada
- Moncton, New Brunswick, Canada
- Saint John, New Brunswick, Canada
- Halifax, Nova Scotia, Canada
- Brampton, Ontario, Canada
- Burlington, Ontario, Canada
- Burlington, Ontario, Canada
- Cambridge, Ontario, Canada
- Cambridge, Ontario, Canada
- Greater Sudbury, Ontario, Canada
- Greater Sudbury, Ontario, Canada
- Grimsby, Ontario, Canada
- Hamilton, Ontario, Canada
- Hamilton, Ontario, Canada
- London, Ontario, Canada
- London, Ontario, Canada
- Mississauga, Ontario, Canada
- Newmarket, Ontario, Canada
- Newmarket, Ontario, Canada
- Oakville, Ontario, Canada
- Oshawa, Ontario, Canada
- Oshawa, Ontario, Canada
- Ottawa, Ontario, Canada
- Peterborough, Ontario, Canada
- Scarborough Village, Ontario, Canada
- Toronto, Ontario, Canada
- Waterloo, Ontario, Canada
- Windsor, Ontario, Canada
- Chicoutimi, Quebec, Canada
- Laval, Quebec, Canada
- Lévis, Quebec, Canada
- Montreal, Quebec, Canada
- Montreal, Quebec, Canada
- Sherbrooke, Quebec, Canada
- Terrebonne, Quebec, Canada
- Thetford-Mines, Quebec, Canada
- Trois-Rivières, Quebec, Canada
- Ontario, Canada
- Québec, Canada
- Temuco, Araucania, Chile
- Temuco, Araucania, Chile
- Temuco, Araucania, Chile
- Concepción, Bío-Bío, Chile
- _and 365 more_

## Recent Field Changes (last 30 days)

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---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01776424.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01776424*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*