A Randomized Comparison of CLOpidogrel Monotherapy Versus Extended Dual-antiplatelet Therapy Beyond 12 Months After Implantation of Drug-eluting StEnts in High-risk Lesions or Patients; A-CLOSE Trial

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators hypothesized that clopidogrel mono-therapy will not be inferior to the extended DAPT in terms of the occurrence of both ischemic and bleeding events, for lesions or patients at high risk for either ischemic or bleeding complications 12 months after drug-eluting stent (DES) implantation.

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

Details

• Lead Sponsor: Yonsei University
• Treatments: Aspirin; Clopidogrel

Criteria

Inclusion Criteria:

1. Patients >19 years old

2. Patients who underwent DES implantation 12 months (+5 months) previously.

3. High risk characteristics (clinical or lesion) for ischemic events (must at least one)

High risk patients; clinical criteria

1. Acute coronary syndrome

2. Previous history of cerebrovascular accidents

3. History of peripheral artery intervention

4. Heart failure (left ventricular ejection fraction ≤40%)

5. Diabetes treated with medication

6. Chronic renal insufficiency including end-stage renal diseases

High risk lesions; angiographic or procedural criteria

1. Left main diseases

2. Bifurcation lesions

3. Chronic total occlusion

4. In-stent restenotic lesions

5. Graft lesions

6. Diffuse long lesions requiring total stent length ≥28 mm

7. Calcified lesions requiring atherectomy

8. Multivessel coronary artery disease with multiple stents

9. Small vessel disease requiring stent diameter of ≤2.5 mm

Exclusion Criteria:

1. Age> 80 years

2. Pregnant women or women with potential childbearing

3. Life expectancy < 1 year

4. Refusal or inability to understand of informed consent