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Safety and Efficacy of Six Months Dual Antiplatelet Therapy After Drug-Eluting Stenting (ISAR-SAFE)

This study is not yet open for participant recruitment.
Verified by Deutsches Herzzentrum Muenchen, June 2008

Sponsored by: Deutsches Herzzentrum Muenchen
Information provided by: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT00661206
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Drug: Clopidogrel
Drug: Placebo
Phase IV

MedlinePlus related topics:   Coronary Artery Disease   

ChemIDplus related topics:   Clopidogrel    Clopidogrel Bisulfate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of 6 Months Versus 12 Months Clopidogrel Therapy After Implantation of a Drug-Eluting Stent

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • Composite of death, myocardial infarction, stent thrombosis, stroke or TIMI major bleeding. [ Time Frame: 9 months after randomization ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The individual components of the primary endpoint [ Time Frame: 9 months after randomization ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   6000
Study Start Date:   October 2008
Estimated Study Completion Date:   January 2012
Estimated Primary Completion Date:   October 2011 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Clopidogrel: Active Comparator 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: Placebo Comparator Drug: Placebo
Patients randomized in this group will receive placebo for 6 months.

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Patients on clopidogrel therapy at 6 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
  • Acute 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
  • Enrollment in another clinical trial at the same time.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661206

Contacts
Contact: Julinda Mehilli, MD     49-89-1218 ext 4073     mehilli@dhm.mhn.de    
Contact: Stefanie Schulz, MD     49-89-1218 ext 1521     schulzs@dhm.mhn.de    

Locations
Germany
Deutsches Herzzentrum Muenchen     Not yet recruiting
      Munich, Germany, D-80636
      Contact: Julinda Mehilli, MD         mehilli@dhm.mhn.de    
      Principal Investigator: Julinda Mehilli, MD            
Medizinische Klinik, Klinikum rechts der Isar     Not yet recruiting
      Munich, Germany, 81675
      Contact: Josef Dirschinger, MD     49-89-4041-2947     dirschinger@med1.med.tum.de    
      Principal Investigator: Josef Dirschinger            
Netherlands
St. Antonius Hospital Department of Cardiology     Not yet recruiting
      Nieuwegein, Netherlands, 3435
      Contact: Jurriёn M ten Berg, MD         jurtenberg@wxs.nl    
      Principal Investigator: Jurriёn M ten Berg, MD            

Sponsors and Collaborators
Deutsches Herzzentrum Muenchen

Investigators
Study Chair:     Adnan Kastrati, MD     Deutsches Herzzentrum Muenchen    
Principal Investigator:     Julinda Mehilli, MD     Deutsches Herzzentrum Muenchen    
Principal Investigator:     Jurriёn M ten Berg, MD     Department of Cardiology; St. Antonius Hospital; 3435 CM Nieuwegein; The Netherlands    
  More Information

Responsible Party:   Deutsches Herzzentrum Muenchen ( Prof. A. Schömig )
Study ID Numbers:   GE IDE No. A01207
First Received:   April 15, 2008
Last Updated:   June 18, 2008
ClinicalTrials.gov Identifier:   NCT00661206
Health Authority:   Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Deutsches Herzzentrum Muenchen:
Clopidogrel  
Drug-eluting stent  

Study placed in the following topic categories:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Clopidogrel
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:
Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2008




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