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

Coronary Artery Disease Clinical Trial

— ISAR-SAFE  

Official title:

Randomized, Double-Blind, Placebo-controlled Trial of 6 vs. 12 Months Clopidogrel Therapy After Implantation of a Drug-Eluting Stent

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00661206
• Other study ID #: GE IDE No. A01207
• Status: Active, not recruiting
• Phase: Phase 4
• First received: April 15, 2008
• Last updated: October 8, 2014
• Start date: September 2008
• Est. completion date: November 2014

Study information

• Verified date: October 2014
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4005
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Clopidogrel
Patients on clopidogrel therapy at 6 months after implantation of a drug-eluting stent will be randomized to an additional 6 month period of clopidogrel 75mg per day
• Placebo
Patients randomized in this group will receive placebo for 6 months.

Locations

Country	Name	City	State
Albania	Spitali Gjerman	Tirana
Austria	Krankenanstalt Rudolfstiftung	Wien
Austria	Wilhelminenspital Wien	Wien
Belgium	University Hospitals Leuven	Leuven
China	Shenyang Northern Hospital	Shenyang
Denmark	Aarhus University Hospital	Aarhus
Germany	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	Klinikum München-Großhadern	München
Germany	Städtisches Klinikum München-Neuperlach	München
Germany	1st Medizinische Klinik, Klinikum rechts der Isar	Munich
Germany	Deutsches Herzzentrum München	Munich
Germany	Klinikum Bogenhausen	Munich
Germany	Lukaskrankenhaus GmbH, Städtische Kliniken Neuss	Neuss
Germany	Klinikum Barmherzige Brüder Regensburg	Regensburg
Germany	Universitätsklinikum Regensburg	Regensburg
Germany	Universitätsklinik Rostock	Rostock
Germany	Universitätsklinikum Ulm	Ulm
Germany	HELIOS Klinikum Wuppertal-Herzzentrum	Wuppertal
Ireland	University College Hospital Galway	Galway
Italy	Campus Biomedico University of Rome	Rome
Japan	Tokai University School of Medicine	Isehara
Japan	Kyoto University Hospital	Kyoto
Netherlands	Catharina Hospital Eindhoven	Eindhoven
Netherlands	St. Antonius Hospital Department of Cardiology	Nieuwegein
Netherlands	Maasstad Ziekenhuis	Rotterdam
Netherlands	Isala klinieken, locatie Weezenlanden	Zwolle
New Zealand	Auckland City Hospital	Auckland
Switzerland	Inselspital, Universitätsspital Bern	Bern
United States	University of Florida, Health Science Center - Jacksonville	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen

Countries where clinical trial is conducted

United States,  Albania,  Austria,  Belgium,  China,  Denmark,  Germany,  Ireland,  Italy,  Japan,  Netherlands,  New Zealand,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of death, myocardial infarction, stent thrombosis, stroke or TIMI major bleeding.		9 months after randomization	Yes
Secondary	The individual components of the primary endpoint		9 months after randomization	Yes