Overview

This trial is active, not recruiting.

Conditions coronary artery disease, atrial fibrillation
Treatments aspirin, clopidogrel, oral anticoagulation
Phase phase 4
Sponsor Deutsches Herzzentrum Muenchen
Start date September 2008
End date December 2013
Trial size 614 participants
Trial identifier NCT00776633, GE IDE No. A01508

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
6 weeks triple therapy
aspirin
6 weeks triple therapy with aspirin, clopidogrel and oral anticoagulation
clopidogrel
6 months triple therapy with aspirin, clopidogrel and oral anticoagulation
oral anticoagulation
(Active Comparator)
6 months triple therapy
aspirin
6 weeks triple therapy with aspirin, clopidogrel and oral anticoagulation
clopidogrel
6 months triple therapy with aspirin, clopidogrel and oral anticoagulation
oral anticoagulation

Primary Outcomes

Measure
Composite of death, myocardial infarction, definite stent thrombosis, stroke or major bleeding.
time frame: 9 months

Secondary Outcomes

Measure
Ischemic complications (composite of cardiac death, myocardial infarction, stent thrombosis or ischemic stroke)
time frame: 9 months
Bleeding complications (Major bleeding)
time frame: 9 months

Eligibility Criteria

Male or female participants at least 18 years old.

Key Inclusion Criteria: 1. Patients with an indication for oral anticoagulation and a DES implantation. 2. Informed, written consent by the patient or her/his legally-authorized representative for participation in the study. Key Exclusion Criteria: 1. Age ≤18 years 2. Previous stent thrombosis 3. DES in left main

Additional Information

Official title 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
Principal investigator Stefanie Schulz, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Deutsches Herzzentrum Muenchen.