Abrupt Versus Tapered Interruption of Chronic Clopidogrel Therapy After DES Implantation

Study Overview
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Brief Summary
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The hypothesis to be tested is that gradual clopidogrel therapy cessation is associated with a superior clinical outcome compared with abrupt cessation (superiority hypothesis).

Detailed Description
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A possible rebound in platelet activity after clopidogrel withdrawal has been suggested in patients on chronic clopidogrel therapy. However, a systematic evaluation of the role of rapid thienopyridine withdrawal on ischemic complications in patients with treated coronary artery disease has not been addressed by specifically designed studies. The objective of this study is to evaluate the safety and efficacy of abrupt or tapered interruption of chronic clopidogrel therapy after intracoronary drug-eluting stent implantation.

Official Title
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Prospective, Randomized, Double-Blind Trial of Abrupt and Tapered Interruption of Long-term Clopidogrel Therapy After Implantation of a Drug-Eluting Stent

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Abrupt Clopidogrel Interruption
* Drug: Clopidogrel Tapering


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with planned interruption of chronic clopidogrel therapy after DES implantation Informed, written consent by the patient Exclusion Criteria: Planned surgery within the next month Active bleeding as reason for clopidogrel discontinuation Concomitant coumadin therapy Pregnancy (present, suspected or planned) or positive pregnancy test (In women with childbearing potential a negative pregnancy test is mandatory) Malignancies or other comorbid conditions with a life expectancy of less than one year or that may result in protocol noncompliance. Patient's inability to fully comply with the study protocol.

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 Tapering<br> | Drug: Clopidogrel Tapering<br>* Patients assigned to this group will have Clopidogrel gradually decreased according to a fixed tapering schema of Clopidogrel and Placebo over 4 weeks.<br>* Other names: Plavix;|
| Active Comparator: Abrupt Clopidogrel Interruption<br> | Drug: Abrupt Clopidogrel Interruption<br>* Patients assigned to this group will receive Clopidogrel 75mg per day for an additional period of 4 weeks. Afterwards they will stop the drug abruptly.<br>* Other names: Plavix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of cardiac death, myocardial infarction, stent thrombosis, stroke, major bleeding or rehospitalization due to acute coronary syndrome. |  | 3 months after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The individual components of the primary endpoint. All cause mortality. |  | 3 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