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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03947229
• Other study ID #: 4-2019-0234
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: August 14, 2019
• Est. completion date: August 2026

Study information

• Verified date: November 2023
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3200
• Est. completion date: August 2026
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

Inclusion criteria (must all met)

1. Patients >19 years old

2. Patients who underwent DES implantation 12 months (-1 to +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

5. Need for chronic oral anticoagulation

6. History of major bleeding within 3 months prior to randomization

Related Conditions & MeSH terms

• Coronary Artery Disease
• DES

Intervention

Drug:
• Clopidogrel mono-therapy
Patients will receive clopidogrel (75 mg once daily) monotherapy without co-administration of aspirin for 24 months after randomization.
• Dual-antiplatelet therapy
Patients will receive co-administration of aspirin (100 mg/day) and clopidogrel (75 mg/day) for 24 months after randomization.

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiology, Severance Cardiovascular Hospital Yonsei University College of Medicine, 250 Seongsanno, Seodaemun-gu 120-752 Seoul, South Korea	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Net Adverse Clinical Events (NACE)	The composite of all-cause of death, myocardial infarction (MI), stent thrombosis, stroke, or bleeding (BARC type 2, 3, or 5)	24 months
Secondary	Each component of net adverse clinical events		24 months
Secondary	All-cause or cardiovascular mortality		24 months
Secondary	Major or minor bleeding	Major or minor bleeding would be defined by BARC and TIMI criteria	24 months
Secondary	Major adverse cardiac event	Major Adverse Cardiac events includes all-cause of death, myocardial infarctions, stent thrombosis, or stroke.	24 months
Secondary	Major adverse cardiac and cerebrovascular event	Major or minor bleeding would be defined by BARC and TIMI criteria Major Adverser Cardiac events includes all-cause of death, myocardial infarctionh, stent thrombosis, or ischemia-driven target vessel revascularization Major adverse cardiac and cerebrovascular event includes all-cause death, myocardial infarction, stent thrombosis, stroke, or ischemia-driven target vessel revascularization	24 months