Cardiac EventPhase 4OACARTNCT07796217
Comparison of Clopidogrel-based Antiplatelet Agent Treatment and Aspirin Plus Low Dose Rivaroxaban Therapy
A Phase 4 study testing Aspirin and low-dose rivaroxaban and Clopidogrel with or without aspirin in people with Cardiac Event and Coronary Artery Disease, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The study aims to conduct a randomized controlled trial among adults aged 19 years or older who have experienced acute myocardial infarction at least one year prior, or who have other comorbidities such as peripheral arterial disease or multiple cardiovascular diseases, and have consented to participate in the study. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cardiac Event, Coronary Artery Disease, Peripheral Artery Disease
- What is being tested?
- Aspirin and low-dose rivaroxaban and Clopidogrel with or without aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,758 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Nov 2023to 31 Dec 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 65 years of age who have experienced acute myocardial infarction and have multivessel coronary artery disease (CAD) that has been present for over one year
- Patients who have peripheral arterial disease (history of PTA or bypass, history of foot/leg amputation, intermittent claudication with ABI <0.9 or over 50% stenosis in peripheral arteries, or over 50% stenosis in coronary arteries or previous coronary stent implantation) and have a history of acute myocardial infarction for over one year or have one of the two conditions: multivessel CAD.
- Subject is able to verbally confirm understandings of risks, benefits and treatment, and he/she or his/her legally authorized representative provides written informed consent prior to study
Who cannot join
- History of serious hypersensitivity reactions to aspirin, clopidogrel, or prasugrel.
- Patients with coagulation disorders or liver diseases related to coagulation, as well as patients with moderate (Child Pugh B) and severe (Child Pugh C) liver dysfunction.
- Severe renal impairment with a creatinine clearance less than 15 mL/min.
- Patients who require long-term combination therapy with other anticoagulants such as unfractionated heparin (UFH), low molecular weight heparin (enoxaparin, dalteparin, etc.), heparinoids (fondaparinux, etc.), oral anticoagulants (warfarin, apixaban, dabigatran, etc.).
- In cases of active clinical bleeding at the time of study registration.
- Patients who require discontinuation of antiplatelet therapy for more than 3 months due to surgery or procedure
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- Individuals with an expected lifespan of less than 3 years due to reasons other than cardiovascular disease.
- Concomitant use of the following contraindicated drugs: other P2Y12 inhibitors (prasugrel or ticagrelor); cytochrome P450 2C19 inhibitors (fluoxetine, fluvoxamine, or voriconazole); probenecid; high-dose methotrexate (≥15 mg/week); lithium.
- Pregnant or breastfeeding women.
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National Universtiy Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Chang-Hwan Yoon, MD, +82 31 787 7052, changhwanyoon@gmail.com
About this study
Official title: Optimal Strategy for Treatment of Atherosclerotic Cardiovascular Disease - Comparison of Clopidogrel-based Antiplatelet Agent Treatment Versus Aspirin Plus Low Dose Rivaroxaban Therapy
The study aims to conduct a randomized controlled trial among adults aged 19 years or older who have experienced acute myocardial infarction at least one year prior, or who have other comorbidities such as peripheral arterial disease or multiple cardiovascular diseases, and have consented to participate in the study. Participants will be randomly assigned to either a group that maintains antiplatelet therapy with aspirin and clopidogrel or clopidogrel alone, or a group that maintains combined antiplatelet and anticoagulant therapy with aspirin and low-dose rivaroxaban in a 1:1 ratio. The study aims to demonstrate that maintaining clopidogrel-based antiplatelet therapy is not clinically inferior to maintaining combined therapy with aspirin and low-dose rivaroxaban.
Read the detailed description
Rupture of atherosclerotic plaques and resulting thrombotic or embolic events can lead to myocardial infarction, stroke, and death. Particularly after vascular interventions such as percutaneous coronary intervention, stent implantation, or peripheral vascular interventions, it takes more than a year for the damaged endothelial cells to heal completely, leading to frequent thrombotic complications. In addition, clinically undiagnosed atrial fibrillation, stroke caused by thrombosis formation due to venous damage, myocardial infarction, deep vein thrombosis, and pulmonary embolism may occur. Therefore, drug therapy to prevent thrombosis is necessary for these patients, and many studies have been conducted to determine the optimal treatment.
Dual antiplatelet therapy (DAPT) with aspirin and clopidogrel is essential for treating patients after percutaneous coronary intervention (PCI). DAPT can minimize ischemic events not only in stent lesions but also in non-reperfused lesions of the coronary artery. However, DAPT increases the risk of bleeding, so a treatment strategy is needed to minimize ischemic events while reducing the risk of bleeding by using dual antiplatelet therapy for a short time after the procedure, administering antiplatelet drugs differently depending on the bleeding risk. In particular, in patients at high risk of bleeding (HBR), the side effects of bleeding due to long-term antiplatelet therapy are closely related to long-term survival, making this issue even more important. Compared to traditional aspirin use, the use of clopidogrel has been reported to reduce mortality, myocardial infarction, stroke, and hospitalization due to acute coronary artery disease while reducing bleeding complications.
In addition, a study has reported that combining low-dose anticoagulants with aspirin as a thromboprophylactic agent for stable atherosclerotic patients who were previously treated only with antiplatelet drugs reduces mortality and has superior effects on the prevention of myocardial infarction and stroke compared to aspirin alone. Aspirin and low-dose rivaroxaban combination therapy has been approved for use in patients with multivessel CAD who are over 65 years of age and have experienced acute myocardial infarction for more than one year, as well as patients with peripheral arterial disease (PAD) (history of PTA or bypass, history of foot/leg amputation, intermittent claudication with ABI <0.9, or over 50% stenosis in peripheral arteries, or over 50% stenosis in coronary arteries or previous coronary stent implantation) who have one of the two conditions: a history of acute myocardial infarction for over one year or multivessel CAD.
Ultimately, studies comparing clopidogrel and low-dose rivaroxaban and aspirin combination therapy in similar patient populations have shown the superiority of each treatment strategy, but no studies have compared the two treatment strategies. If clopidogrel monotherapy is more convenient to take, has better compliance, and is not less effective than low-dose rivaroxaban and aspirin combination therapy, it may be considered as a more convenient treatment strategy for many patients.
- Being tested
- Aspirin and low-dose rivaroxaban, Clopidogrel with or without aspirin
- Keywords
- Anti-platelet therapy, anticoagulant therapy
- Medical subject headings
- Cardiovascular Diseases, Coronary Artery Disease, Peripheral Arterial Disease, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin and low-dose rivaroxabanDrug
Also called Aspirin + low-dose rivaroxaban (2.5mg bid)
Combination of aspirin and low-dose rivaroxaban
Clopidogrel with or without aspirinDrug
Also called clopidogrel-based SAPT or DAPT
Clopidogrel-based SAPT or DAPT at the clinician's discretion
| Study group | Role | What they receive |
|---|---|---|
| Combination of antiplatelet and low-dose anticoagulant agents | Experimental | A group that maintains combined antiplatelet and anticoagulant therapy with aspirin and low-dose rivaroxaban Receives: Drug: Aspirin and low-dose rivaroxaban |
| Conventional use of clopidogrel-based antiplatelet therapy with or without aspirin | Active comparator | A group that maintains clopidogrel-based antiplatelet therapy, with or without aspirin, at the clinician's discretion Receives: Drug: Clopidogrel with or without aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient oriented cardiac event
All-cause death, any myocardial infarction, any stroke, any revascularization (coronary or peripheral disease), acute limb ischemia (including all major vascular amputations), any acute thromboembolism, and BARC classification ≥ 2
Measured: 36 months
Secondary outcomes (7)
Patient oriented cardiac event in CAD only group
All-cause death, any myocardial infarction, any stroke, any revascularization (coronary or peripheral disease), acute limb ischemia (including all major vascular amputations), any acute thromboembolism, and BARC classification ≥ 2
Measured: 36 months
Patient oriented cardiac event in PAD only group
All-cause death, any myocardial infarction, any stroke, any revascularization (coronary or peripheral disease), acute limb ischemia (including all major vascular amputations), any acute thromboembolism, and BARC classification ≥ 2
Measured: 36 months
Composite of MI, stroke or CV death
Myocardial infarction, stroke or cardiovascular death measured by percent of participants with adverse events
Measured: 36 months
Composite of MI, stroke or CV death in CAD only group
Myocardial infarction, stroke or cardiovascular death measured by percent of coronary disease participants with adverse events
Measured: 36 months
Composite of MI, stroke or CV death in CAD and PAD group
Myocardial infarction, stroke or cardiovascular death measured by percent of all participants with adverse events
Measured: 36 months
Patency of target lesion in PAD intervention group
Measured by percent of participants undergone repeat PTA to the previous lesion
Measured: 36 months
Composite of major thrombotic events
Cardiovascular death, MI, ischemic stroke, stent thrombosis or acute limb ischemia, venous thromboembolism (Deep vein thrombosis or pulmonary embolism)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start15 Nov 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiac EventStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- None (open label)
- Enrolment
- 2,758 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korea University Guro Hospital, Korea University Ansan Hospital, Korea University Anam Hospital, Chungnam National University Sejong Hospital, National Health Insurance Service Ilsan Hospital, Ewha Womans University Seoul Hospital, Konyang University Hospital, Seoul National University Hospital, KangWon National University Hospital, Sejong General Hospital, Inha University Hospital, Severance Hospital, Myongji Hospital, Chonnam National University Hospital, Chungnam National University Hospital, Jeju National University Hospital, Kwangju christian hospital, Soonchunhyang University Hospital, Wonju Severance Christian Hospital
- Responsible party
- Principal investigator, Chang-Hwan Yoon, Seoul National University Bundang Hospital
- Investigators
- In-Ho Chae, M.D Ph.D, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796217
- Sponsor's protocol ID
- B-2304-820-003
- Acronym
- OACART
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Valgimigli M, Bueno H, Byrne RA, Collet JP, Costa F, Jeppsson A, Juni P, Kastrati A, Kolh P, Mauri L, Montalescot G, Neumann FJ, Petricevic M, Roffi M, Steg PG, Windecker S, Zamorano JL, Levine GN; ESC Scientific Document Group; ESC Committee for Practice Guidelines (CPG); ESC National Cardiac Societies. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2018 Jan 14;39(3):213-260. doi: 10.1093/eurheartj/ehx419. No abstract available.
PubMed 28886622Knuuti J, Wijns W, Saraste A, Capodanno D, Barbato E, Funck-Brentano C, Prescott E, Storey RF, Deaton C, Cuisset T, Agewall S, Dickstein K, Edvardsen T, Escaned J, Gersh BJ, Svitil P, Gilard M, Hasdai D, Hatala R, Mahfoud F, Masip J, Muneretto C, Valgimigli M, Achenbach S, Bax JJ; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J. 2020 Jan 14;41(3):407-477. doi: 10.1093/eurheartj/ehz425. No abstract available.
PubMed 31504439Aboyans V, Ricco JB, Bartelink MEL, Bjorck M, Brodmann M, Cohnert T, Collet JP, Czerny M, De Carlo M, Debus S, Espinola-Klein C, Kahan T, Kownator S, Mazzolai L, Naylor AR, Roffi M, Rother J, Sprynger M, Tendera M, Tepe G, Venermo M, Vlachopoulos C, Desormais I; ESC Scientific Document Group. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS): Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteriesEndorsed by: the European Stroke Organization (ESO)The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS). Eur Heart J. 2018 Mar 1;39(9):763-816. doi: 10.1093/eurheartj/ehx095. No abstract available.
PubMed 28886620