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

Phase 4

• Conditions: Coronary Artery Disease; Atrial Fibrillation
• Interventions: Drug: aspirin; Drug: clopidogrel; Drug: oral anticoagulation

• Registration Number: NCT00776633
• Lead Sponsor: Deutsches Herzzentrum Muenchen

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-10-20
• Study First Submitted QC: 2008-10-20
• Study First Posted: 2008-10-21
• Primary Completion: 2013-12
• Status Verified: 2014-08
• Study Completion: 2014-09
• Last Update Submitted: 2016-08-29
• Last Update Posted: 2016-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 614

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Short triple	clopidogrel	6 weeks triple therapy
Short triple	oral anticoagulation	6 weeks triple therapy
Long triple	oral anticoagulation	6 months triple therapy
Short triple	aspirin	6 weeks triple therapy
Long triple	aspirin	6 months triple therapy
Long triple	clopidogrel	6 months triple therapy

Primary Outcome Measures

Name	Time	Method
Composite of death, myocardial infarction, definite stent thrombosis, stroke or major bleeding.	9 months

Secondary Outcome Measures

Name	Time	Method
Ischemic complications (composite of cardiac death, myocardial infarction, stent thrombosis or ischemic stroke)	9 months
Bleeding complications (Major bleeding)	9 months

Trial Locations

Locations (3)

Deutsches Herzzentrum München; 🇩🇪 Munich, Germany

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

1. Medizinische Klinik, Klinikum rechts der Isar; 🇩🇪 München, Germany