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Safety and Efficacy of Six Months Dual Antiplatelet Therapy After Drug-Eluting Stenting (ISAR-SAFE)
This study is currently recruiting participants.
Verified by Deutsches Herzzentrum Muenchen, June 2009
First Received: April 15, 2008   Last Updated: June 19, 2009   History of Changes
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

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 vs. 12 Months Clopidogrel Therapy After Implantation of a Drug-Eluting Stent

Resource links provided by NLM:


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: September 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: September 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 (-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.
  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
Belgium
University Hospitals Leuven Recruiting
Leuven, Belgium, 3000
Contact: Tom Adriaenssens, MD         tadriaenssens@hotmail.com    
Principal Investigator: Tom Adriaenssens, MD            
Germany
1st Medizinische Klinik, Klinikum rechts der Isar Recruiting
Munich, Germany, 81675
Contact: Josef Dirschinger, MD     49-89-4041-2947     dirschinger@med1.med.tum.de    
Principal Investigator: Josef Dirschinger            
Deutsches Herzzentrum München Recruiting
Munich, Germany, 81541
Contact: Julinda Mehilli, MD     +49-89-1218 ext 4582     mehilli@dhm.mhn.de    
Contact: Stefanie Schulz, MD     +49-89-1218 ext 1521     schulzs@dhm.mhn.de    
Principal Investigator: Julinda Mehilli, MD            
Segeberger Kliniken GmbH Not yet recruiting
Bad Segeberg, Germany, 23795
Contact: Gerd Richardt, Prof.            
Principal Investigator: Gerd Richardt, MD            
Herzzentrum Bad Krozingen Not yet recruiting
Bad Krozingen, Germany, 79189
Contact: Franz-Josef Neumann, MD            
Principal Investigator: Franz-Josef Neumann, MD            
Ireland
University College Hospital Galway Recruiting
Galway, Ireland
Contact: Kieran Daly, MD         kieran.daly@hse.ie    
Principal Investigator: Kieran Daly, MD            
Italy
Campus Biomedico University of Rome Recruiting
Rome, Italy, 00128
Contact: Germano Di Sciascio, MD         g.disciascio@unicampus.it    
Principal Investigator: Germano Di Sciascio, MD            
Netherlands
St. Antonius Hospital Department of Cardiology 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

No publications provided

Responsible Party: Deutsches Herzzentrum Muenchen ( Prof. A. Schömig )
Study ID Numbers: GE IDE No. A01207
Study First Received: April 15, 2008
Last Updated: June 19, 2009
ClinicalTrials.gov Identifier: NCT00661206     History of Changes
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
Platelet Aggregation Inhibitors
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Heart Diseases
Myocardial Ischemia
Hematologic Agents
Vascular Diseases
Arteriosclerosis
Pharmacologic Actions
Coronary Disease
Clopidogrel
Therapeutic Uses
Cardiovascular Diseases
Platelet Aggregation Inhibitors
Coronary Artery Disease

ClinicalTrials.gov processed this record on July 02, 2009