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

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ClinicalTrials.gov Identifier: NCT00776633
Recruitment Status : Unknown
Verified August 2014 by Deutsches Herzzentrum Muenchen.
Recruitment status was:  Active, not recruiting
First Posted : October 21, 2008
Last Update Posted : August 30, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Atrial Fibrillation Drug: aspirin Drug: clopidogrel Drug: oral anticoagulation Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 614 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2008
Primary Completion Date : December 2013
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Short triple
6 weeks triple therapy
Drug: aspirin
6 weeks triple therapy with aspirin, clopidogrel and oral anticoagulation
Drug: clopidogrel
6 months triple therapy with aspirin, clopidogrel and oral anticoagulation
Drug: oral anticoagulation
Active Comparator: Long triple
6 months triple therapy
Drug: aspirin
6 weeks triple therapy with aspirin, clopidogrel and oral anticoagulation
Drug: clopidogrel
6 months triple therapy with aspirin, clopidogrel and oral anticoagulation
Drug: oral anticoagulation


Outcome Measures

Primary Outcome Measures :
  1. Composite of death, myocardial infarction, definite stent thrombosis, stroke or major bleeding. [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Ischemic complications (composite of cardiac death, myocardial infarction, stent thrombosis or ischemic stroke) [ Time Frame: 9 months ]
  2. Bleeding complications (Major bleeding) [ Time Frame: 9 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00776633


Locations
Denmark
Aarhus University Hospital
Aarhus, Denmark, 8200
Germany
Deutsches Herzzentrum München
Munich, Germany, 80636
1. Medizinische Klinik, Klinikum rechts der Isar
München, Germany, 81675
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:
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
First Posted: October 21, 2008    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2014

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
Ticlopidine
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists