Official Title: “Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of 6 Months Versus 12 Months Clopidogrel Therapy After Implantation of a Drug-Eluting Stent”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2011

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Clopidogrel
• Placebo Comparator: Placebo

Primary Measures

• Composite of death, myocardial infarction, stent thrombosis, stroke or TIMI major bleeding.
  • Time Frame: 9 months after randomization
    Safety Issue?: Yes

Secondary Measures

• The individual components of the primary endpoint
  • Time Frame: 9 months after randomization
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Deutsches Herzzentrum Muenchen

Overall Clinical Trial Officials and Contacts

Adnan Kastrati, MD Study Chair Deutsches Herzzentrum Muenchen  

Overall Contact: Julinda Mehilli, MD 49-89-1218 mehilli@dhm.mhn.de

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00661206

Study ID Number: GE IDE No. A01207

ClinicalTrials.gov Identifier: NCT00661206

Health Authority: Germany: Federal Institute for Drugs and Medical Devices