SMart Angioplasty Research Team: CHoice of Optimal Anti-Thrombotic Strategy in Patients Undergoin… (NCT04418479) | Clinical Trial Compass
CompletedPhase 4
SMart Angioplasty Research Team: CHoice of Optimal Anti-Thrombotic Strategy in Patients Undergoing Implantation of Coronary Drug-Eluting Stents 3
South Korea5,506 participantsStarted 2020-08-10
Plain-language summary
This study is a prospective, open-label, two-arm, randomized multicenter trial to compare the efficacy and safety of clopidogrel versus aspirin monotherapy beyond the standard duration of dual antiplatelet therapy (DAPT) (more than 12 months for myocardial infarction \[MI\] and more than 6 months for non-MI) after percutaneous coronary intervention (PCI) in patients at high risk of recurrent ischemic events.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. Subject must be at least 19 years of age
✓. Patients at high risk of recurrence of ischemic events who have undergone PCI using a DES and are receiving standard DAPT (12 months\* or more for myocardial infarction and 6 months\* or more for non-myocardial infarction)
✓. Patients at high risk for recurrent ischemic events, which were defined as one or more of the following clinical or lesion characteristics.
✓. Patients with prior myocardial infarction.
✓. Patients with diabetes mellitus who receive oral hypoglycemic agent or insulin.
✓. True bifurcation lesion (Medina 1,1,1/1,0,1/0,1,1) and is able to assess the side branch ostium
✓. Chronic total occlusion (≥3 months) as target lesion
✓. PCI for unprotected left main disease (left main ostium, body, or distal bifurcation including non-true bifurcation lesions)
Exclusion criteria
✕. Known hypersensitivity or contraindications to study medications (aspirin or clopidogrel)
✕. Patients who need continuous anticoagulant therapy.
✕. Patients who require DAPT due to atherosclerotic disease other than coronary artery disease
✕. Patients who are scheduled for revascularization treatment of coronary artery
What they're measuring
1
Rates of major adverse cardiac and cerebrovascular event (MACCE)
✕. A patient who are taking single antiplatelet therapy at screening
✕. Pregnant or lactating women
✕. Non-cardiac co-morbid conditions are present with life expectancy \<2 year or that may result in protocol non-compliance (per site investigator's medical judgment)