Key result
Planned OACART trial tests if clopidogrel-based therapy matches aspirin plus low-dose rivaroxaban in high-risk atherosclerosis.
Why the study?
Clopidogrel and dual pathway inhibition with aspirin plus low-dose rivaroxaban both show benefits in stable atherosclerotic disease, but no studies have directly compared these strategies.
Does clopidogrel-based antiplatelet therapy with or without aspirin reduce the net clinical outcome in patients with chronic stable high-risk CAD or CAD+PAD compared to aspirin plus low-dose rivaroxaban?
RCT (n=2,758)
Open-label
1:1
Yes
Does clopidogrel-based antiplatelet therapy with or without aspirin reduce the net clinical outcome in patients with chronic stable high-risk CAD or CAD+PAD compared to aspirin plus low-dose rivaroxaban?
This study protocol describes a randomized trial comparing the efficacy and safety of clopidogrel-based antiplatelet therapy versus aspirin plus low-dose rivaroxaban in patients with high-risk stable atherosclerosis.
Answers are grounded in this paper and cite their sources.
May clarify optimal antiplatelet choice in high-risk ASCVD; extends randomized evidence comparing clopidogrel-based therapy versus dual pathway inhibition.
Recent studies have demonstrated the superior benefits of clopidogrel compared to aspirin in reducing mortality, myocardial infarction, stroke, and hospitalization in chronic stable patients with coronary stenting. Furthermore, dual pathway inhibition by combining low-dose rivaroxaban with aspirin (DPI) has shown superior effects in preventing cardiovascular death, myocardial infarction, and stroke in stable atherosclerotic patients. However, no studies have directly compared these treatment strategies in the same population. This randomized controlled trial aims to compare clopidogrel-based antiplatelet therapy with or without aspirin (CAPT) to DPI in a 1:1 ratio in patients with high-risk coronary artery disease (CAD) or in patients with both CAD and peripheral artery disease (PAD). Optimal strategy for treatment of A therosclerotic cardiovascular disease—comparison of C lopidogrel-based A ntiplatelet agent treatment versus aspirin plus low dose R ivaroxaban T herapy (OACART) trial is a randomized multi-center study comparing the performance of the maintaining CAPT or DPI in a 1:1 ratio. The trial is powered for the non-inferiority of the CAPT in patients with chronic stable high-risk CAD or CAD+PAD to DPI with respect to the primary and secondary efficacy endpoints at 36 months. Between November 2023 and April 2026, we will recruit 2758 participants from multi-center in Korea, and we will examine the net clinical outcome, including all-cause death, any myocardial infarction, any stroke, any ischemia-driven revascularization (CAD or PAD), acute limb ischemia, any major or minor amputations, any acute thromboembolism, and International Society on Thrombosis and Haemostasis major bleeding at 36 months after study enrollment. OACART trial will provide the optimal antithrombotic treatment strategy for patients with stable high-risk atherosclerosis. Clinical Research Information Service (CRIS) of Republic of Korea, KCT0008458, registered on May 22, 2023. https://cris.nih.go.kr/cris/search/detailSearch.do?seq=28968&search_page=L
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Kwun et al. (2026) conducted an RCT in Atherosclerotic cardiovascular disease (high-risk CAD or CAD + PAD) (n=2,758). Clopidogrel-based antiplatelet therapy with or without aspirin (CAPT) vs. Aspirin 81-100 mg daily plus rivaroxaban 2.5 mg twice daily (DPI) was evaluated on Net clinical outcome (all-cause death, MI, stroke, ischemia-driven revascularization, acute limb ischemia, major/minor amputations, acute thromboembolism, and ISTH major bleeding) at 36 months. The OACART trial is a planned randomized study designed to evaluate whether clopidogrel-based antiplatelet therapy is non-inferior to aspirin plus low-dose rivaroxaban in high-risk atherosclerosis.
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