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Optimal Strategy for Treatment of Atherosclerotic Cardiovascular Disease - Comparison of Clopidogrel-based Antiplatelet Agent Treatment Versus Aspirin Plus Low Dose Rivaroxaban Therapy

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Republic of Korea
Seoul National Universtiy Bundang Hospital
RECRUITING
Seongnam-si
Contact Information
Primary
Ju Seung Kwun, M.D
jkwun0413@gmail.com
+82 31 787 7841
Backup
Chang-Hwan Yoon, M.D Ph.D
changhwanyoon@gmail.com
+82 31 787 7052
Time Frame
Start Date: 2023-11-15
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 2758
Treatments
Experimental: Combination of antiplatelet and low-dose anticoagulant agents
A group that maintains combined antiplatelet and anticoagulant therapy with aspirin and low-dose rivaroxaban
Active_comparator: Conventional use of clopidogrel-based antiplatelet therapy with or without aspirin
A group that maintains clopidogrel-based antiplatelet therapy, with or without aspirin, at the clinician's discretion
Sponsors
Collaborators: Seoul National University Hospital, Konyang University Hospital, Chonnam National University Hospital, Chungnam National University Sejong Hospital, National Health Insurance Service Ilsan Hospital, Korea University Guro Hospital, Ewha Womans University Seoul Hospital, Chungnam National University Hospital, Korea University Ansan Hospital, KangWon National University Hospital, Inha University Hospital, Myongji Hospital, Sejong General Hospital, Severance Hospital, Kwangju christian hospital, Soonchunhyang University Hospital, Korea University Anam Hospital, Wonju Severance Christian Hospital, Jeju National University Hospital
Leads: Seoul National University Bundang Hospital

This content was sourced from clinicaltrials.gov