Comparison of Clopidogrel-based Antiplatelet Agent Treatment and Aspirin Plus Low Dose Rivaroxaban Therapy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorSeoul National University Bundang Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.).
Trial design
Design model
Parallel
Treatments tested in this trial
Aspirin and low-dose rivaroxaban
DrugCombination of aspirin and low-dose rivaroxaban
Clopidogrel with or without aspirin
DrugClopidogrel-based SAPT or DAPT at the clinician's discretion
Treatment groups
2,758 Participants
are divided into 2 treatment groupsGroup A: Combination of antiplatelet and low-dose anticoagulant agentsExperimental treatment 1 intervention
Group B: Conventional use of clopidogrel-based antiplatelet therapy with or without aspirinActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
36 monthsSecondary outcomes
1
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
Time frame
36 months2
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
Time frame
36 months3
Composite of MI, stroke or CV death
Myocardial infarction, stroke or cardiovascular death measured by percent of participants with adverse events
Time frame
36 months4
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
Time frame
36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Seoul National University Bundang Hospital
Lead sponsor
Korea University Guro Hospital
Collaborator
Korea University Ansan Hospital
Collaborator
Korea University Anam Hospital
Collaborator
Chungnam National University Sejong Hospital
Collaborator
National Health Insurance Service Ilsan Hospital
Collaborator
Ewha Womans University Seoul Hospital
Collaborator
Konyang University Hospital
Collaborator
Seoul National University Hospital
Collaborator
KangWon National University Hospital
Collaborator
Sejong General Hospital
Collaborator
Inha University Hospital
Collaborator
Severance Hospital
Collaborator
Myongji Hospital
Collaborator
Chonnam National University Hospital
Collaborator
Chungnam National University Hospital
Collaborator
Jeju National University Hospital
Collaborator
Kwangju christian hospital
Collaborator
Soonchunhyang University Hospital
Collaborator
Wonju Severance Christian Hospital
Collaborator
Source ClinicalTrials.gov