Tailored Antiplatelet Therapy for High-Risk Patients At 12 Months after Drug-Eluting Stent implantatio

Not Applicable

Recruiting

Conditions: Diseases of the circulatory system

Registration Number: KCT0008489

Lead Sponsor: Yonsei University Health System, Severance Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 3434

Inclusion Criteria

1. Patients > 18 years old
2. atients who previously underwent percutaneous coronary intervention with drug-eluting stent implantation 12 months (± 3 months) ago.
3. At least one high risk characteristics of ischemic events

High risk patients
1) Acute coronary syndrome
2) Previous history of cerebrovascular accidents
3) Previous history of peripheral artery intervention
4) Heart failure
5) Diabetes mellitus requiring medication
6) Chronic kidney disease (regardless of requirement of renal replacement therapy)

High risk lesions
1) Left main disease
2) Multivessel disease, 2- or 3- vessels
3) Bifurcation lesions requiring 2 or more stents
4) Chronic total occlusion
5) In-stent restenosis
6) Graft lesions
7) Diffuse long lesion requiring stent(s) with total stent length =28 mm
8) Lesion at small sized vessel requiring stent(s) with stent diameter =2.5 mm
9) Calcified lesions requiring atherectomy

Exclusion Criteria

1. Patients > 80 years old
2. Pregnant women or women with potential childbearing
3. Life expectancy < 1 year
4. Refusal or inability to understand of informed consent
5. Patients eligible to long-term anticoagulation therapy
6. Patients with major bleeding events in previous 3 months before randomization

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
et clinical adverse event [NACE]

Secondary Outcome Measures

Name	Time	Method
All-cause death ;Cardiovascular death;Myocardial infarction;Stent thrombosis;Ischemia-driven target vessel revascularization;Any revascularization;Stroke;BARC type 2, 3, or 5 bleeding;BARC type 3, or 5 bleeding;BARC type 2 bleeding;BARC type 3 bleeding;BARC type 5 bleeding;All-cause death, myocardial infarction, or stroke;Cardiovascular death, myocardial infarction, stent thrombosis, or stroke;All-cause death, myocardial infarction, stent thrombosis, stroke, or BARC type 3 or 5 bleeding