Triple Therapy in Patients on Oral Anticoagulation After Drug Eluting Stent Implantation

Study Overview
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Brief Summary
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The investigators hypothesize that reducing the duration of clopidogrel therapy from 6 months to 6 weeks after DES implantation is associated with improved clinical outcomes in patients on ASA and an oral anticoagulant.

Detailed Description
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The introduction of drug-eluting stents (DES) was associated not only with a widening of the indication for percutaneous coronary intervention (PCI) but also with longer antithrombotic therapy duration. Dual antiplatelet therapy with ASA and a thienopyridine is very efficient in preventing adverse events after coronary stenting but it is inferior to oral anticoagulation (OAC) to reduce the risk of stroke in patients with atrial fibrillation. OAC is also superior to antiplatelet therapy in patients with mechanical heart valves and the therapy of choice for the treatment of deep vein thrombosis and pulmonary embolism. OAC is also administered for left ventricular thrombi and low ejection fraction. There is an increasing number of patients undergoing coronary stenting who are in need of life-long anticoagulation therapy and would therefore require a triple therapy consisting of aspirin, clopidogrel and oral anticoagulation. As oral anticoagulation and antithrombotic therapy impair primary and secondary hemostasis there are concerns that adding warfarin to dual antiplatelet therapy might cause increased bleeding rates. Several studies have retrospectively assessed efficacy and safety in patients receiving a triple therapy with various results: major bleeding rates varied from 3,1%-14,9% with total bleeding rates up to 27,5%. Prospective randomized data on this topic are not available. Therefore the aim of this study is to compare a 6 week versus a 6 month triple therapy after DES implantation.

Official Title
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Intracoronary Stenting and Antithrombotic Regimen: Testing of a Six-week Versus a Six-month Clopidogrel Treatment Regimen in Patients With Concomitant Aspirin and Oral Anticoagulant Therapy Following Drug-eluting Stenting

Conditions
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Coronary Artery Disease, Atrial Fibrillation

Intervention / Treatment
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* Drug: aspirin
* Drug: clopidogrel
* Drug: oral anticoagulation


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Patients with an indication for oral anticoagulation and a DES implantation. Informed, written consent by the patient or her/his legally-authorized representative for participation in the study. Key Exclusion Criteria: Age ≤18 years Previous stent thrombosis DES in left main

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 |
| --- | --- |
| Experimental: Short triple<br>6 weeks triple therapy | Drug: aspirin<br>* 6 weeks triple therapy with aspirin, clopidogrel and oral anticoagulation<br>Drug: clopidogrel<br>* 6 months triple therapy with aspirin, clopidogrel and oral anticoagulation<br>Drug: oral anticoagulation<br> <br> |
| Active Comparator: Long triple<br>6 months triple therapy | Drug: aspirin<br>* 6 weeks triple therapy with aspirin, clopidogrel and oral anticoagulation<br>Drug: clopidogrel<br>* 6 months triple therapy with aspirin, clopidogrel and oral anticoagulation<br>Drug: oral anticoagulation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ischemic complications (composite of cardiac death, myocardial infarction, stent thrombosis or ischemic stroke) |  | 9 months | 
| Bleeding complications (Major bleeding) |  | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aspirin, clopidogrel, oral anticoagulation, warfarin, drug eluting stent, phenprocoumon