Duration of Clopidogrel Therapy After Drug-Eluting Stent (DES-LATE)

Study Overview
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Brief Summary
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This is randomized-controlled trial to evaluate the difference of composite of cardiac death, myocardial infarction, or Stroke between the dual antiplatelet therapy group and the aspirin monotherapy group after 1-year of drug-eluting stents implantation.

Detailed Description
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This is subsequent clinical trial of previously published pooled analysis of the REAL-LATE and the ZEST-LATE Trial, in which nonsignificant higher trend for increased rate of death (all-cause and cardiac), myocardial infarction, or stroke in the dual antiplatelet therapy group compared to the aspirin monotherapy group was noted.

Official Title
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Optimal Duration of Clopidogrel Therapy After Drug-Eluting Stent Implantation to Reduce Late Coronary Arterial Thrombotic Events

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Aspirin monotherapy
* Drug: Aspirin,Clopidogrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Patients had undergone DES implantation at least 12 months before enrollment, had not had a MACE (death, MI, stroke, or repeat revascularization) or major bleeding, and were dual-therapy at the time of enrollment. 2. Time for index PCI to randomization: 12-18 months Exclusion Criteria: Contraindications to the use of antiplatelet drugs (e.g., a concurrent bleeding diathesis or a history of major bleeding) Concomitant vascular disease requiring long-term use of clopidogrel Other established indications for clopidogrel therapy (e.g., a recent ACS). Noncardiac coexisting conditions with a life expectancy < 1 year.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aspirin<br>Aspirin monotherapy (stopping clopidogrel at 1 year after DES) | Drug: Aspirin monotherapy<br>* stopping clopidogrel at 1 year after DES<br>|
| Experimental: Aspirin,Clopidogrel<br>Aspirin,Clopidogrel Dual antiplatelet therapy (continue aspirin and clopidogrel 1year after DES) | Drug: Aspirin,Clopidogrel<br>* continue aspirin and clopidogrel 1year after DES<br>* Other names: Aspirin,Clopidogrel Dual antiplatelet therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The composite of cardiac death, myocardial infarction, or stroke |  | at 2 year after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death |  | at 2 year after randomization | 
| myocardial infarction |  | at 2 year after randomization | 
| stroke |  | at 2 year after randomization | 
| stent thrombosis |  | at 2 year after randomization | 
| Thrombolysis In Myocardial Infarction (TIMI) major/minor bleeding |  | at 2 year after randomization | 
| Target Vessl revascularization |  | at 2 year after randomization | 
| Target Lesion Revascularization |  | at 2 year after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary disease, stents, antiplatelet drugs, drug-eluting stents