Coronary Artery Disease Clinical Trial
— ISAR-TRIPLEOfficial 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
Verified date | August 2014 |
Source | Deutsches Herzzentrum Muenchen |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 614 |
Est. completion date | September 2014 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University Hospital | Aarhus | |
Germany | 1. Medizinische Klinik, Klinikum rechts der Isar | München | |
Germany | Deutsches Herzzentrum München | Munich |
Lead Sponsor | Collaborator |
---|---|
Deutsches Herzzentrum Muenchen |
Denmark, Germany,
Rubboli A, Halperin JL, Airaksinen KE, Buerke M, Eeckhout E, Freedman SB, Gershlick AH, Schlitt A, Tse HF, Verheugt FW, Lip GY. Antithrombotic therapy in patients treated with oral anticoagulation undergoing coronary artery stenting. An expert consensus document with focus on atrial fibrillation. Ann Med. 2008;40(6):428-36. doi: 10.1080/07853890802089786. Review. — View Citation
Schömig A, Neumann FJ, Kastrati A, Schühlen H, Blasini R, Hadamitzky M, Walter H, Zitzmann-Roth EM, Richardt G, Alt E, Schmitt C, Ulm K. A randomized comparison of antiplatelet and anticoagulant therapy after the placement of coronary-artery stents. N Engl J Med. 1996 Apr 25;334(17):1084-9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite of death, myocardial infarction, definite stent thrombosis, stroke or major bleeding. | 9 months | Yes | |
Secondary | Ischemic complications (composite of cardiac death, myocardial infarction, stent thrombosis or ischemic stroke) | 9 months | Yes | |
Secondary | Bleeding complications (Major bleeding) | 9 months | Yes |
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