NCT07796217 Comparison of Clopidogrel-based Antiplatelet Agent Treatment and Aspirin Plus Low Dose Rivaroxaban Therapy
| NCT ID | NCT07796217 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Seoul National University Bundang Hospital |
| Condition | Cardiac Event |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,758 participants |
| Start Date | 2023-11-15 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 2,758 participants in total. It began in 2023-11-15 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
Contact & Investigator
In-Ho Chae, M.D Ph.D
PRINCIPAL INVESTIGATOR
Seoul National University Bundang Hospital
Frequently Asked Questions
Who can join the NCT07796217 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Cardiac Event. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07796217 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07796217 currently recruiting?
Yes, NCT07796217 is actively recruiting participants. Contact the research team at jkwun0413@gmail.com for enrollment information.
Where is the NCT07796217 trial being conducted?
This trial is being conducted at Seongnam-si, South Korea.
Who is sponsoring the NCT07796217 clinical trial?
NCT07796217 is sponsored by Seoul National University Bundang Hospital. The principal investigator is In-Ho Chae, M.D Ph.D at Seoul National University Bundang Hospital. The trial plans to enroll 2,758 participants.