Optimal strategy for treatment of atherosclerotic cardiovascular disease—comparison of clopidogrel-based antiplatelet agent treatment versus aspirin plus low dose rivaroxaban therapy (OACART study): a study protocol for a multicenter, open-label, randomized, non-inferiority trial

@article{kwun2026optimal,
  title = {{Optimal strategy for treatment of atherosclerotic cardiovascular disease—comparison of clopidogrel-based antiplatelet agent treatment versus aspirin plus low dose rivaroxaban therapy (OACART study): a study protocol for a multicenter, open-label, randomized, non-inferiority trial}},
  author = {Ju-Seung Kwun and Chang-Hwan Yoon and Ki-Hyun Jeon and Hyoung-won Cho and Jin Joo Park and Si-Hyuck Kang and Wonjae Lee and Jung-Won Suh and Tae-Jin Youn and Hyun-Jae Kang and Pil-ki Min and Cheol Woong Yu and Jae-Hwan Lee and Seung-Woon Rha and Sanghoon Shin and Bong-Ki Lee and Young Jin Youn and Young-Guk Ko and Ji-Yong Jang and Jae-Kwang Lee and Kyoung-Ha Park and Young Jin Choi and Sang-Rok Lee and Sang-Don Park and Deok-Kyu Cho and Yun-Hyeong Cho and Ju Han Kim and Jin-Ok Jeong and Janghyun Cho and Song-Yi Kim and Tae Soo Kang and Seung-Uk Lee and In-Ho Chae},
  journal = {Trials},
  year = {2026},
  month = jul,
  doi = {10.1186/s13063-026-09899-7},
  url = {https://doi.org/10.1186/s13063-026-09899-7},
  note = {CC BY-NC-ND 4.0},
}

TY  - JOUR
TI  - Optimal strategy for treatment of atherosclerotic cardiovascular disease—comparison of clopidogrel-based antiplatelet agent treatment versus aspirin plus low dose rivaroxaban therapy (OACART study): a study protocol for a multicenter, open-label, randomized, non-inferiority trial
AU  - Ju-Seung Kwun
AU  - Chang-Hwan Yoon
AU  - Ki-Hyun Jeon
AU  - Hyoung-won Cho
AU  - Jin Joo Park
AU  - Si-Hyuck Kang
AU  - Wonjae Lee
AU  - Jung-Won Suh
AU  - Tae-Jin Youn
AU  - Hyun-Jae Kang
AU  - Pil-ki Min
AU  - Cheol Woong Yu
AU  - Jae-Hwan Lee
AU  - Seung-Woon Rha
AU  - Sanghoon Shin
AU  - Bong-Ki Lee
AU  - Young Jin Youn
AU  - Young-Guk Ko
AU  - Ji-Yong Jang
AU  - Jae-Kwang Lee
AU  - Kyoung-Ha Park
AU  - Young Jin Choi
AU  - Sang-Rok Lee
AU  - Sang-Don Park
AU  - Deok-Kyu Cho
AU  - Yun-Hyeong Cho
AU  - Ju Han Kim
AU  - Jin-Ok Jeong
AU  - Janghyun Cho
AU  - Song-Yi Kim
AU  - Tae Soo Kang
AU  - Seung-Uk Lee
AU  - In-Ho Chae
PY  - 2026
DA  - 2026/07/30
JO  - Trials
DO  - 10.1186/s13063-026-09899-7
UR  - https://doi.org/10.1186/s13063-026-09899-7
AB  - Background: 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).  Methods: Optimal strategy for treatment of Atherosclerotic cardiovascular disease—comparison of Clopidogrel-based Antiplatelet agent treatment versus aspirin plus low dose Rivaroxaban Therapy (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.  Results: 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.  Conclusions: OACART trial will provide the optimal antithrombotic treatment strategy for patients with stable high-risk atherosclerosis.  Trial registration: 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  Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1186/s13063-026-09899-7.
SN  - 1745-6215
ER  -