Safety and Efficacy of Six Months Dual Antiplatelet Therapy After Drug-Eluting Stenting

Status unconfirmed · Phase 4 · Has a placebo group

Conditions studied: Coronary Artery Disease

In brief

The purpose of this study is to determine whether a 6 month duration of clopidogrel therapy after DES implantation is not inferior to that of a 12 month therapy.

Key facts

Study ID

NCT00661206

Run by

Deutsches Herzzentrum Muenchen

People needed

4005

Starts

2008-09-01

Expected to finish

2014-11-01

Last updated by the study team

2014-10-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients on clopidogrel therapy at 6 months (-1/+2 months) after DES implantation
• Informed, written consent by the patient

You may not qualify if…

• Age ≤18 years
• Clinically symptoms, proof of ischemia and/or presence of angiographic lesions requiring revascularization
• Previous stent thrombosis
• DES in left main coronary artery
• ST-elevation and non-ST-elevation myocardial infarction during the last 6 months
• Malignancies or other comorbid conditions with a life expectancy of less than one year or that may result in protocol noncompliance
• Planned major surgery within the next 6 months with the need to discontinue antiplatelet therapy
• Active bleeding; bleeding diathesis; history intracranial bleeding
• Oral anticoagulation therapy with coumadin derivatives
• Known allergy or intolerance to the study medications: aspirin and clopidogrel
• Pregnancy (present, suspected or planned) or positive pregnancy test (In women with childbearing potential a negative pregnancy test is mandatory)
• Patient's inability to fully comply with the study protocol
• Prior enrollment in the same clinical trial.

Where it is running

• University of Florida, Health Science Center - Jacksonville — Jacksonville, Florida, United States
• Spitali Gjerman — Tirana, Albania
• Krankenanstalt Rudolfstiftung — Vienna, Austria
• Wilhelminenspital Wien — Vienna, Austria
• University Hospitals Leuven — Leuven, Belgium
• Shenyang Northern Hospital — Shenyang, China
• Aarhus University Hospital — Aarhus, Denmark
• Herzzentrum Bad Krozingen — Bad Krozingen, Germany
• Segeberger Kliniken GmbH — Bad Segeberg, Germany
• Charité Berlin, Campus Benjamin Franklin — Berlin, Germany
• Technische Universität Dresden — Dresden, Germany
• Universitätsklinikum Erlangen — Erlangen, Germany
• Klinikum Garmisch-Partenkirchen — Garmisch-Partenkirchen, Germany
• Universitätsmedizin Göttingen — Göttingen, Germany
• Klinikum Ingolstadt — Ingolstadt, Germany
• MediClin Herzzentrum Lahr/Baden — Lahr, Germany
• Krankenhaus Landshut-Achdorf — Landshut, Germany
• Herzzentrum Leipzig — Leipzig, Germany
• Universitätsklinikum Schleswig-Holstein, Campus Lübeck — Lübeck, Germany
• Deutsches Herzzentrum München — Munich, Germany
• 1st Medizinische Klinik, Klinikum rechts der Isar — Munich, Germany
• Klinikum Bogenhausen — Munich, Germany
• Klinikum München-Großhadern — München, Germany
• Städtisches Klinikum München-Neuperlach — München, Germany
• Lukaskrankenhaus GmbH, Städtische Kliniken Neuss — Neuss, Germany

Full record on ClinicalTrials.gov

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