Safety and Efficacy of Six Months Dual Antiplatelet Therapy After Drug-Eluting Stenting

Study Overview
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Brief Summary
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The purpose of this study is to determine whether a 6 month duration of clopidogrel therapy after DES implantation is not inferior to that of a 12 month therapy.

Detailed Description
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Drug elution from stent struts is associated with less smooth muscle cell proliferation and delayed stent strut re-endothelialization. Thus it seems conceivable that a longer duration of dual antiplatelet therapy (aspirin and clopidogrel) after DES implantation is needed. However, no studies have been done to investigate which is the optimal antiplatelet therapy duration after DES implantation. Therefore, the objective of the randomized, double-blind, placebo-controlled ISAR-SAFE study is to evaluate the safety and efficacy of a 6 month versus a 12 month duration of clopidogrel therapy after DES implantation. Patients on clopidogrel therapy at least 6 months after DES implantation, who do not require a reintervention will be randomized to an additional 6 month period of clopidogrel or placebo. The patients will be followed-up for 9 months after randomization.

Official Title
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Randomized, Double-Blind, Placebo-controlled Trial of 6 vs. 12 Months Clopidogrel Therapy After Implantation of a Drug-Eluting Stent

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Clopidogrel
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients on clopidogrel therapy at 6 months (-1/+2 months) after DES implantation Informed, written consent by the patient Exclusion Criteria: Age ≤18 years Clinically symptoms, proof of ischemia and/or presence of angiographic lesions requiring revascularization Previous stent thrombosis DES in left main coronary artery ST-elevation and non-ST-elevation myocardial infarction during the last 6 months Malignancies or other comorbid conditions with a life expectancy of less than one year or that may result in protocol noncompliance Planned major surgery within the next 6 months with the need to discontinue antiplatelet therapy Active bleeding; bleeding diathesis; history intracranial bleeding Oral anticoagulation therapy with coumadin derivatives Known allergy or intolerance to the study medications: aspirin and clopidogrel Pregnancy (present, suspected or planned) or positive pregnancy test (In women with childbearing potential a negative pregnancy test is mandatory) Patient's inability to fully comply with the study protocol Prior enrollment in the same clinical trial.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clopidogrel<br> | Drug: Clopidogrel<br>* Patients on clopidogrel therapy at 6 months after implantation of a drug-eluting stent will be randomized to an additional 6 month period of clopidogrel 75mg per day<br>* Other names: ACT-Code: B01AC/04;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Patients randomized in this group will receive placebo for 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of death, myocardial infarction, stent thrombosis, stroke or TIMI major bleeding. |  | 9 months after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The individual components of the primary endpoint |  | 9 months after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clopidogrel, Drug-eluting stent