SMart Angioplasty Research Team: CHoice of Optimal Anti-Thrombotic Strategy in Patients Undergoing Implantation of Coronary Drug-Eluting Stents 3

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study is prospective, open-label, two-arm, randomized multicenter trial to evaluate the efficacy and safety of clopidogrel monotherapy as compared with aspirin monotherapy beyond 12 months after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in patients being treated with dual antiplatelet therapy (DAPT) at high risk for recurrent ischemic events.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center
• Treatments: Aspirin; Clopidogrel

Criteria

Inclusion Criteria:

i) Subject must be at least 19 years of age

ii) Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily.

iii) Patients being treated with DAPT at high risk for recurrent ischemic events* who underwent PCI at least 12 months ago.

*High risk for recurrent ischemic events was defined as one or more of the following clinical or lesion characteristics.

A. Clinical characteristics

1. Patients presented with acute myocardial infarction.

2. Patients with diabetes mellitus who receiving oral hypoglycemic agent or insulin.

B. Complex lesion characteristics**

**Complex lesion was defined as one or more of the following.

1. True bifurcation lesion (Medina 1,1,1/1,0,1/0,1,1) and is able to assess the side branch ostium

2. Chronic total occlusion (≥3 months) as target lesion

3. PCI for unprotected left main disease (left main ostium, body, or distal bifurcation including non-true bifurcation lesions)

4. Long coronary lesions (implanted stent length ≥38 mm)

5. Multi-vessel PCI (≥ 2 vessels treated at one PCI session)

6. Multiple stent needed (≥ 3 stents per patient)

7. In-stent restenosis lesion as target lesion

8. Severely calcified lesion (encircling calcium in angiography)

9. Ostial lesions of left anterior descending artery, left circumflex artery, or right coronary artery

Exclusion Criteria:

i) Known hypersensitivity or contraindications to study medications (aspirin or clopidogrel)

ii) Patients taking warfarin or non-vitamin K antagonist (dabigatran, rivaroxaban, edoxaban, or apixaban)

iii) Patients who require DAPT due to atherosclerotic disease other than coronary artery disease

iv) Patients who are scheduled for revascularization treatment of coronary artery

v) Pregnant or lactating women

vi) 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)