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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00661206
Recruitment Status : Unknown
Verified October 2014 by Deutsches Herzzentrum Muenchen.
Recruitment status was:  Active, not recruiting
First Posted : April 18, 2008
Last Update Posted : October 9, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Clopidogrel Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4005 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-controlled Trial of 6 vs. 12 Months Clopidogrel Therapy After Implantation of a Drug-Eluting Stent
Study Start Date : September 2008
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Arm Intervention/treatment
Active Comparator: Clopidogrel 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
Other Names:
  • Plavix
  • ACT-Code: B01AC/04

Placebo Comparator: Placebo Drug: Placebo
Patients randomized in this group will receive placebo for 6 months.

Primary Outcome Measures :
  1. Composite of death, myocardial infarction, stent thrombosis, stroke or TIMI major bleeding. [ Time Frame: 9 months after randomization ]

Secondary Outcome Measures :
  1. The individual components of the primary endpoint [ Time Frame: 9 months after randomization ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00661206

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Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
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Study Chair: Adnan Kastrati, MD Deutsches Herzzentrum Muenchen
Principal Investigator: Adnan Kastrati, MD Deutsches Herzzentrum Muenchen
Principal Investigator: Jurriёn M ten Berg, MD St. Antonius Hospital Nieuwegein, Department of Cardiology
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Deutsches Herzzentrum Muenchen Identifier: NCT00661206    
Other Study ID Numbers: GE IDE No. A01207
First Posted: April 18, 2008    Key Record Dates
Last Update Posted: October 9, 2014
Last Verified: October 2014
Keywords provided by Deutsches Herzzentrum Muenchen:
Drug-eluting stent
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs