Triple Therapy in Patients on Oral Anticoagulation After Drug Eluting Stent Implantation (ISAR-TRIPLE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Deutsches Herzzentrum Muenchen
Sponsor:
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00776633
First received: October 20, 2008
Last updated: February 13, 2014
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Atrial Fibrillation
Drug: 6 weeks
Drug: 6 months
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • Composite of death, myocardial infarction, definite stent thrombosis, stroke or major bleeding. [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Ischemic complications (composite of cardiac death, myocardial infarction, stent thrombosis or ischemic stroke) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Bleeding complications (Major bleeding) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 600
Study Start Date: September 2008
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Short triple
6 weeks triple therapy
Drug: 6 weeks
6 weeks triple therapy with aspirin, clopidogrel and oral anticoagulation
Active Comparator: Long triple
6 months triple therapy
Drug: 6 months
6 months triple therapy with aspirin, clopidogrel and oral anticoagulation

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00776633

Contacts
Contact: Adnan Kastrati, MD +498912184578 kastrati@dhm.mhn.de

Locations
Denmark
Aarhus University Hospital Not yet recruiting
Aarhus, Denmark, 8200
Contact: Michael Maeng, MD       michael.maeng@ki.au.dk   
Contact: Helle Bargsteen       hellbarg@rm.dk   
Principal Investigator: Michael Maeng, MD         
Germany
Deutsches Herzzentrum München Recruiting
Munich, Germany, 80636
Contact: Adnan Kastrati, MD    +498912184578    kastrati@dhm.mhn.de   
Sub-Investigator: Anette Fiedler, MD         
1. Medizinische Klinik, Klinikum rechts der Isar Recruiting
München, Germany, 81675
Contact: Karl-Ludwig Laugwitz, MD    +498941402350      
Sub-Investigator: Petra Hoppmann, MD         
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Investigators
Study Chair: Adnan Kastrati, MD Deutsches Herzzentum München
Principal Investigator: Stefanie Schulz, MD Deutsches Herzzentrum Muenchen
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT00776633     History of Changes
Other Study ID Numbers: GE IDE No. A01508
Study First Received: October 20, 2008
Last Updated: February 13, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Deutsches Herzzentrum Muenchen:
aspirin
clopidogrel
oral anticoagulation
warfarin
drug eluting stent
phenprocoumon

Additional relevant MeSH terms:
Atrial Fibrillation
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors

ClinicalTrials.gov processed this record on August 26, 2014