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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Deutsches Herzzentrum Muenchen.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00661206
First received: April 15, 2008
Last updated: April 19, 2012
Last verified: April 2012
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

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 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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 1534 schulzs@dhm.mhn.de

  Show 45 Study Locations
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
ClinicalTrials.gov Identifier: NCT00661206     History of Changes
Other Study ID Numbers: GE IDE No. A01207
Study First Received: April 15, 2008
Last Updated: April 19, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clopidogrel
Ticlopidine
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 22, 2014