What was the population size of the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) trial?

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Last updated: May 26, 2025View editorial policy

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From the Guidelines

The COMPASS trial enrolled a total of 27,395 participants. This large-scale randomized controlled trial evaluated the efficacy and safety of rivaroxaban (either alone or in combination with aspirin) compared to aspirin alone in patients with stable atherosclerotic vascular disease, as reported in the study published in Circulation 1. The study population consisted of individuals with coronary artery disease, peripheral arterial disease, or both conditions. This substantial sample size was necessary to provide adequate statistical power to detect differences in cardiovascular outcomes between the treatment groups. The large population also allowed researchers to evaluate the safety profile of the different antithrombotic regimens across a diverse patient population, making the findings more generalizable to real-world clinical practice.

  • The COMPASS trial results were also discussed in other studies, including those published in the European Heart Journal 1, Diabetes Care 1, Journal of the American College of Cardiology 1, and Med 1, all of which confirmed the enrollment of 27,395 participants.
  • The trial's findings have significant implications for the management of patients with stable atherosclerotic vascular disease, and the use of rivaroxaban in combination with aspirin has been shown to reduce the risk of major adverse cardiovascular events, including cardiovascular death, stroke, and myocardial infarction, as noted in the studies 1.

From the Research

Population of the COMPASS Trial

  • The COMPASS trial had a total of 27,395 participants who were randomized and followed up to February 6,2017 2.
  • These participants had stable atherosclerotic vascular disease and were eligible for the study, which was performed in 33 countries from March 12,2013, to May 10,2016 2.
  • The study population included patients with ischemic heart disease, as well as those with atherosclerosis in other beds, such as peripheral arterial disease 3.
  • Sub-studies from the COMPASS trial examined other high-risk populations who might benefit the most from the regimen of low-dose rivaroxaban plus aspirin 3.

Demographics of the Study Population

  • The mean age of the participants who experienced an ischemic stroke was 69.4 years, with a standard deviation of 8.5 years 2.
  • 66 of the participants who experienced an ischemic stroke were women, and 43 (14.8%) had a previous nonlacunar stroke 2.
  • During the study, 49 patients (16.8%) received a diagnosis of atrial fibrillation 2.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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