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
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|ClinicalTrials.gov Identifier: NCT03947229|
Recruitment Status : Not yet recruiting
First Posted : May 13, 2019
Last Update Posted : May 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease DES||Drug: Clopidogrel mono-therapy Drug: Dual-antiplatelet therapy||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3200 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||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.|
|Masking:||None (Open Label)|
|Masking Description:||Antiplatelet drugs will be open-label and prescribed by attending physician.|
|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|
|Estimated Study Start Date :||June 2019|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||April 2023|
Active Comparator: Clopidogrel mono-therapy
After randomization, patients will receive clopidogrel monotherapy after DES implantation for 24 months.
Drug: Clopidogrel mono-therapy
Patients will receive clopidogrel (75 mg once daily) monotherapy without co-administration of aspirin for 24 months after randomization.
Active Comparator: Dual-antiplatelet therapy
Patients will receive dual antiplatelet consisting of aspirin and clopidogrel.
Drug: Dual-antiplatelet therapy
Patients will receive co-administration of aspirin (100 mg/day) and clopidogrel (75 mg/day) for 24 months after randomization.
- Net Adverse Clinical Events (NACE) [ Time Frame: 24 months ]The composite of all-cause of death, myocardial infarction (MI), stent thrombosis, stroke, or bleeding (BARC type 2, 3, or 5)
- Each component of net adverse clinical events [ Time Frame: 24 months ]
- All-cause or cardiovascular mortality [ Time Frame: 24 months ]
- Major or minor bleeding [ Time Frame: 24 months ]Major or minor bleeding would be defined by BARC and TIMI criteria
- Major adverse cardiac event [ Time Frame: 24 months ]Major Adverse Cardiac events includes all-cause of death, myocardial infarctions, stent thrombosis, or stroke.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03947229
|Korea, Republic of|
|Division of Cardiology, Severance Cardiovascular Hospital Yonsei University College of Medicine, 250 Seongsanno, Seodaemun-gu 120-752 Seoul, South Korea|
|Seoul, Korea, Republic of|