Safety and Efficacy of Six Months Dual Antiplatelet Therapy After Drug-Eluting Stenting
Information source: Deutsches Herzzentrum Muenchen
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Artery Disease
Intervention: Clopidogrel (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Deutsches Herzzentrum Muenchen Official(s) and/or principal investigator(s):
Adnan Kastrati, MD, Study Chair, Affiliation: Deutsches Herzzentrum Muenchen
Julinda Mehilli, MD, Principal Investigator, Affiliation: Deutsches Herzzentrum Muenchen
Jurriёn M ten Berg, MD, Principal Investigator, Affiliation: Department of Cardiology; St. Antonius Hospital; 3435 CM Nieuwegein; The Netherlands
Overall contact:
Julinda Mehilli, MD, Phone: 49-89-1218, Ext: 4073, Email: mehilli@dhm.mhn.de
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.
Clinical Details
Official title: Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of 6 vs. 12 Months Clopidogrel Therapy After Implantation of a Drug-Eluting Stent
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Composite of death, myocardial infarction, stent thrombosis, stroke or TIMI major bleeding.
Secondary outcome: The individual components of the primary endpoint
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
- 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
- Enrollment in another clinical trial at the same time.
Locations and Contacts
Julinda Mehilli, MD, Phone: 49-89-1218, Ext: 4073, Email: mehilli@dhm.mhn.de
1st Medizinische Klinik, Klinikum rechts der Isar, Munich 81675, Germany; Recruiting
Josef Dirschinger, MD, Phone: 49-89-4041-2947, Email: dirschinger@med1.med.tum.de
Josef Dirschinger, Principal Investigator
Deutsches Herzzentrum München, Munich 81541, Germany; Recruiting
Julinda Mehilli, MD, Phone: +49-89-1218, Ext: 4582, Email: mehilli@dhm.mhn.de
Stefanie Schulz, MD, Phone: +49-89-1218, Ext: 1521, Email: schulzs@dhm.mhn.de
Julinda Mehilli, MD, Principal Investigator
St. Antonius Hospital Department of Cardiology, Nieuwegein 3435, Netherlands; Not yet recruiting
Jurriёn M ten Berg, MD, Email: jurtenberg@wxs.nl
Jurriёn M ten Berg, MD, Principal Investigator
Additional Information
Starting date: September 2008
Ending date: December 2011
Last updated: November 3, 2008
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