Cardiovascular OutcoMes for People using Anticoagulation StrategieS (2013,


Prevention of heart attacks, stroke or cardiovascular death in patients with coronary or peripheral artery disease

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To evaluate whether treatment with rivaroxaban and ASA or rivaroxaban alone is better than ASA alone in prevention of major cardiac events in patients with CAD or PAD

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Trial design

Randomized placebo-controlled phase III study, event driven, expected duration 3–4 years

Active treatment:

  • Stratum 1: rivaroxaban 2.5 mg p.o. twice daily plus ASA 100 mg once daily
  • Stratum 2: rivaroxaban 5 mg p.o twice daily plus ASA placebo

Control treatment: ASA 100 mg once daily plus rivaroxaban placebo

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Primary efficacy endpoint: composite of cardiovascular death, myocardial infarction and stroke
Primary safety endpoint: major bleeding
Secondary outcome measures: composite of myocardial infarction, stroke, cardiovascular death, venous thromboembolism and cardiovascular hospitalization, all-cause mortality

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Trial participants

~20,000 patients ≥18 years with documented atherosclerosis related to CAD or PAD plus one of the following inclusion criteria:

  • age ≥65 years
  • age <65 years plus documented atherosclerosis in at least two vascular
    beds or at least 2 additional risk factors

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Reference (NCT01776424)

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Corresponding author

Salim Yusuf, MD, Health Research Institute (PHRI), McMaster University, 237 Barton Street East, Hamilton, ON L8L 2X2, Canada,

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