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

Phase 4

Active, not recruiting

• Conditions: Coronary Artery Disease; DES
• Interventions: Drug: Dual-antiplatelet therapy; Drug: Clopidogrel mono-therapy

• Registration Number: NCT03947229
• Lead Sponsor: Yonsei University

Brief Summary

We 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.

Detailed Description

Patients at high risk for either ischemic or bleeding complications, but who were stable without clinical evetns for 12 months after DES implantation will be included in this study. Eligible patients will be randomized to continue DAPT (aspirin plus clopidogrel) for further 24 months or to change to single antiplatelet therapy with clopidogrel (clopidogrel-alone). Randomization will be stratified according to 1) clinical presentation (acute coronary syndrome or stable coronary artery disease) and 2) age (≥75 or \<75). Baseline clinical and angiographic characteristics, laboratory findings will be assessed at the time of randomization. All patients will provide informed consent on their own initiative. All of study subjects will be have an outpatient visit as scheduled in outpatient clinic. Occurrence of study endpoints will be documented at clinical visit or telephone interview every 6 months up to 24 months after randomization. Antiplatelet drugs will be open-label and prescribed by attending physician.

Study Timeline

• Study First Submitted: 2019-05-08
• Study First Submitted QC: 2019-05-10
• Study First Posted: 2019-05-13
• Study Start: 2019-08-14
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-24
• Primary Completion: 2025-08-16
• Study Completion: 2026-08-16

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 3200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dual-antiplatelet therapy	Dual-antiplatelet therapy	Patients will receive dual antiplatelet consisting of aspirin and clopidogrel.
Clopidogrel mono-therapy	Clopidogrel mono-therapy	After randomization, patients will receive clopidogrel monotherapy after DES implantation for 24 months.

Primary Outcome Measures

Name	Time	Method
Net Adverse Clinical Events (NACE)	24 months	The composite of all-cause of death, myocardial infarction (MI), stent thrombosis, stroke, or bleeding (BARC type 2, 3, or 5)

Secondary Outcome Measures

Name	Time	Method
Each component of net adverse clinical events	24 months
All-cause or cardiovascular mortality	24 months
Major or minor bleeding	24 months	Major or minor bleeding would be defined by BARC and TIMI criteria
Major adverse cardiac event	24 months	Major Adverse Cardiac events includes all-cause of death, myocardial infarction, stent thrombosis, or ischemia-driven target vessel revascularization
Major adverse cardiac and cerebrovascular event	24 months	Major adverse cardiac and cerebrovascular event includes all-cause death, myocardial infarction, stent thrombosis, stroke, or ischemia-driven target vessel revascularization

Trial Locations

Locations (1)

Division of Cardiology, Severance Cardiovascular Hospital Yonsei University College of Medicine, 250 Seongsanno, Seodaemun-gu 120-752 Seoul, South Korea; 🇰🇷 Seoul, Korea, Republic of