Status:
COMPLETED
SMart Angioplasty Research Team: CHoice of Optimal Anti-Thrombotic Strategy in Patients Undergoing Implantation of Coronary Drug-Eluting Stents 3
Lead Sponsor:
Joo-Yong Hahn
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief 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 antipla...
Detailed Description
After the introduction of the second-generation drug-eluting stents (DES), the rates of device-related failure or target lesion failure such as restenosis and stent thrombosis has been markedly decrea...
Eligibility Criteria
Inclusion
- 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.
- A. Clinical characteristics
- Patients with prior myocardial infarction.
- Patients with diabetes mellitus who receive oral hypoglycemic agent or insulin.
- B. Complex lesion characteristics Complex lesion was defined as one or more of the following.
- 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)
- Long coronary lesions (implanted stent length ≥38 mm)
- Multi-vessel PCI (≥ 2 vessels treated at one PCI session)
- Multiple stent needed (≥ 3 stents per patient)
- In-stent restenosis lesion as target lesion
- Severely calcified lesion (encircling calcium in angiography) i . Ostial lesions of left anterior descending artery, left circumflex artery, or right coronary artery
- Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily.
Exclusion
- 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
- 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)
Key Trial Info
Start Date :
August 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 12 2024
Estimated Enrollment :
5506 Patients enrolled
Trial Details
Trial ID
NCT04418479
Start Date
August 10 2020
End Date
November 12 2024
Last Update
January 30 2025
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 06351