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

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

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

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

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

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 2011
Estimated Primary Completion Date:	September 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 (-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 1521	schulzs@dhm.mhn.de

Locations

Belgium
University Hospitals Leuven	Recruiting
Leuven, Belgium, 3000
Contact: Tom Adriaenssens, MD tadriaenssens@hotmail.com
Principal Investigator: Tom Adriaenssens, MD
Germany
1st Medizinische Klinik, Klinikum rechts der Isar	Recruiting
Munich, Germany, 81675
Contact: Josef Dirschinger, MD 49-89-4041-2947 dirschinger@med1.med.tum.de
Principal Investigator: Josef Dirschinger
Deutsches Herzzentrum München	Recruiting
Munich, Germany, 81541
Contact: Julinda Mehilli, MD +49-89-1218 ext 4582 mehilli@dhm.mhn.de
Contact: Stefanie Schulz, MD +49-89-1218 ext 1521 schulzs@dhm.mhn.de
Principal Investigator: Julinda Mehilli, MD
Segeberger Kliniken GmbH	Not yet recruiting
Bad Segeberg, Germany, 23795
Contact: Gerd Richardt, Prof.
Principal Investigator: Gerd Richardt, MD
Herzzentrum Bad Krozingen	Not yet recruiting
Bad Krozingen, Germany, 79189
Contact: Franz-Josef Neumann, MD
Principal Investigator: Franz-Josef Neumann, MD
Ireland
University College Hospital Galway	Recruiting
Galway, Ireland
Contact: Kieran Daly, MD kieran.daly@hse.ie
Principal Investigator: Kieran Daly, MD
Italy
Campus Biomedico University of Rome	Recruiting
Rome, Italy, 00128
Contact: Germano Di Sciascio, MD g.disciascio@unicampus.it
Principal Investigator: Germano Di Sciascio, MD
Netherlands
St. Antonius Hospital Department of Cardiology	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

No publications provided

Responsible Party:	Deutsches Herzzentrum Muenchen ( Prof. A. Schömig )
Study ID Numbers:	GE IDE No. A01207
Study First Received:	April 15, 2008
Last Updated:	June 19, 2009
ClinicalTrials.gov Identifier:	NCT00661206 History of Changes
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
Platelet Aggregation Inhibitors
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Heart Diseases
Myocardial Ischemia
Hematologic Agents
Vascular Diseases
Arteriosclerosis
Pharmacologic Actions

Coronary Disease
Clopidogrel
Therapeutic Uses
Cardiovascular Diseases
Platelet Aggregation Inhibitors
Coronary Artery Disease

ClinicalTrials.gov processed this record on July 02, 2009