Safety and Efficacy of Six Months Dual Antiplatelet Therapy After Drug-Eluting Stenting - Full Text View

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

MedlinePlus related topics:

Coronary Artery Disease

ChemIDplus related topics:

Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

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

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:	October 2008
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	October 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 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.

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


Germany
	Deutsches Herzzentrum Muenchen	Not yet recruiting
	Munich, Germany, D-80636
	Contact: Julinda Mehilli, MD mehilli@dhm.mhn.de
	Principal Investigator: Julinda Mehilli, MD
	Medizinische Klinik, Klinikum rechts der Isar	Not yet recruiting
	Munich, Germany, 81675
	Contact: Josef Dirschinger, MD 49-89-4041-2947 dirschinger@med1.med.tum.de
	Principal Investigator: Josef Dirschinger

Netherlands
	St. Antonius Hospital Department of Cardiology	Not yet 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

Responsible Party:	Deutsches Herzzentrum Muenchen ( Prof. A. Schömig )
Study ID Numbers:	GE IDE No. A01207
First Received:	April 15, 2008
Last Updated:	June 18, 2008
ClinicalTrials.gov Identifier:	NCT00661206
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

Arteriosclerosis

Ischemia

Coronary Artery Disease

Additional relevant MeSH terms:

Therapeutic Uses

Hematologic Agents

Platelet Aggregation Inhibitors

Cardiovascular Diseases

Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2008

Sponsored by:	Deutsches Herzzentrum Muenchen
Information provided by:	Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:	NCT00661206