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

Phase 4

• Conditions: Coronary Artery Disease
• Interventions: Drug: Placebo; Drug: Clopidogrel

• Registration Number: NCT00661206
• Lead Sponsor: Deutsches Herzzentrum Muenchen

Brief Summary

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.

Detailed Description

Drug elution from stent struts is associated with less smooth muscle cell proliferation and delayed stent strut re-endothelialization. Thus it seems conceivable that a longer duration of dual antiplatelet therapy (aspirin and clopidogrel) after DES implantation is needed. However, no studies have been done to investigate which is the optimal antiplatelet therapy duration after DES implantation. Therefore, the objective of the randomized, double-blind, placebo-controlled ISAR-SAFE study is to evaluate the safety and efficacy of a 6 month versus a 12 month duration of clopidogrel therapy after DES implantation.

Patients on clopidogrel therapy at least 6 months after DES implantation, who do not require a reintervention will be randomized to an additional 6 month period of clopidogrel or placebo. The patients will be followed-up for 9 months after randomization.

Study Timeline

• Study First Submitted: 2008-04-15
• Study First Submitted QC: 2008-04-17
• Study First Posted: 2008-04-18
• Study Start: 2008-09
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-08
• Last Update Posted: 2014-10-09
• Primary Completion: 2014-11
• Study Completion: 2014-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4005

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Clopidogrel	Clopidogrel	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The individual components of the primary endpoint	9 months after randomization

Trial Locations

Locations (40)

University of Florida, Health Science Center - Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Spitali Gjerman; 🇦🇱 Tirana, Albania

Krankenanstalt Rudolfstiftung; 🇦🇹 Wien, Austria

Wilhelminenspital Wien; 🇦🇹 Wien, Austria

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Herzzentrum Bad Krozingen; 🇩🇪 Bad Krozingen, Germany

Charité Berlin, Campus Benjamin Franklin; 🇩🇪 Berlin, Germany

Segeberger Kliniken GmbH; 🇩🇪 Bad Segeberg, Germany

Universitätsklinikum Erlangen; 🇩🇪 Erlangen, Germany

Technische Universität Dresden; 🇩🇪 Dresden, Germany

Klinikum Garmisch-Partenkirchen; 🇩🇪 Garmisch-Partenkirchen, Germany

Universitätsmedizin Göttingen; 🇩🇪 Göttingen, Germany

HELIOS Klinikum Wuppertal-Herzzentrum; 🇩🇪 Wuppertal, Germany

Campus Biomedico University of Rome; 🇮🇹 Rome, Italy

University College Hospital Galway; 🇮🇪 Galway, Ireland

Shenyang Northern Hospital; 🇨🇳 Shenyang, China

Klinikum Ingolstadt; 🇩🇪 Ingolstadt, Germany

Herzzentrum Leipzig; 🇩🇪 Leipzig, Germany

Universitätsklinik Rostock; 🇩🇪 Rostock, Germany

Krankenhaus Landshut-Achdorf; 🇩🇪 Landshut, Germany

Deutsches Herzzentrum München; 🇩🇪 Munich, Germany

MediClin Herzzentrum Lahr/Baden; 🇩🇪 Lahr, Germany

Universitätsklinikum Schleswig-Holstein, Campus Lübeck; 🇩🇪 Lübeck, Germany

St. Antonius Hospital Department of Cardiology; 🇳🇱 Nieuwegein, Netherlands

Maasstad Ziekenhuis; 🇳🇱 Rotterdam, Netherlands

Städtisches Klinikum München-Neuperlach; 🇩🇪 München, Germany

Tokai University School of Medicine; 🇯🇵 Isehara, Japan

Klinikum München-Großhadern; 🇩🇪 München, Germany

Lukaskrankenhaus GmbH, Städtische Kliniken Neuss; 🇩🇪 Neuss, Germany

Universitätsklinikum Ulm; 🇩🇪 Ulm, Germany

Catharina Hospital Eindhoven; 🇳🇱 Eindhoven, Netherlands

Kyoto University Hospital; 🇯🇵 Kyoto, Japan

Isala klinieken, locatie Weezenlanden; 🇳🇱 Zwolle, Netherlands

Inselspital, Universitätsspital Bern; 🇨🇭 Bern, Switzerland

Auckland City Hospital; 🇳🇿 Auckland, New Zealand

1st Medizinische Klinik, Klinikum rechts der Isar; 🇩🇪 Munich, Germany

Klinikum Bogenhausen; 🇩🇪 Munich, Germany

Universitätsklinikum Regensburg; 🇩🇪 Regensburg, Germany

Klinikum Barmherzige Brüder Regensburg; 🇩🇪 Regensburg, Germany

University Hospitals Leuven; 🇧🇪 Leuven, Belgium