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

NCT03947229 | Active Not Recruiting Phase 4

• 1 other identifier: 4-2019-0234
• Study Type: interventional
• Target: 3,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; DES

Keywords

Patients who underwent percutaneous coronary intervention with DES implantation carrying high risks for the recurrent major adverse events.; anti platelet therapy; bleeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Each component of net adverse clinical events

  24 months

• All-cause or cardiovascular mortality

  24 months

• Major or minor bleeding

  24 months

• Major adverse cardiac event

  24 months

• Major adverse cardiac and cerebrovascular event

  24 months

Study Arms (2)

Clopidogrel mono-therapy

ACTIVE COMPARATOR

After randomization, patients will receive clopidogrel monotherapy after DES implantation for 24 months.

Drug: Clopidogrel mono-therapy

Dual-antiplatelet therapy

ACTIVE COMPARATOR

Patients will receive dual antiplatelet consisting of aspirin and clopidogrel.

Drug: Dual-antiplatelet therapy

Interventions

Clopidogrel mono-therapy DRUG

Patients will receive clopidogrel (75 mg once daily) monotherapy without co-administration of aspirin for 24 months after randomization.

Clopidogrel mono-therapy

Dual-antiplatelet therapy DRUG

Patients will receive co-administration of aspirin (100 mg/day) and clopidogrel (75 mg/day) for 24 months after randomization.

Dual-antiplatelet therapy

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \>19 years old
• Patients who underwent DES implantation 12 months (-1 to +5 months) previously.
• High risk characteristics (clinical or lesion) for ischemic events (must at least one)
• High risk patients; clinical criteria
• Acute coronary syndrome
• Previous history of cerebrovascular accidents
• History of peripheral artery intervention
• Heart failure (left ventricular ejection fraction ≤40%)
• Diabetes treated with medication
• Chronic renal insufficiency including end-stage renal diseases
• High risk lesions; angiographic or procedural criteria
• Left main diseases
• Bifurcation lesions
• Chronic total occlusion
• In-stent restenotic lesions

You may not qualify if:

• Age\> 80 years
• Pregnant women or women with potential childbearing
• Life expectancy \< 1 year
• Refusal or inability to understand of informed consent
• Need for chronic oral anticoagulation
• History of major bleeding within 3 months prior to randomization

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease; Hemorrhage

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Antiplatelet drugs will be open-label and prescribed by attending physician.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be assigned to continue DAPT (aspirin plus clopidogrel) or to change to single antiplatelet therapy with clopidogrel (clopidogrel-alone) for further 24 months.

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 13, 2019
• Study Start: August 14, 2019
• Primary Completion: August 16, 2025
• Study Completion (Estimated): August 16, 2026
• Last Updated: October 24, 2024

Record last verified: 2024-10

Locations

KR (1)