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
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03947229|
Recruitment Status : Recruiting
First Posted : May 13, 2019
Last Update Posted : August 22, 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|
|Actual Study Start Date :||August 14, 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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||Recruiting|
|Seoul, Korea, Republic of|
|Contact: Byeong-Keuk Kim, PhD 82-2-2228-8460 firstname.lastname@example.org|