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

Sponsor:	Deutsches Herzzentrum Muenchen
Information provided by (Responsible Party):	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:	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:

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 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 1521	schulzs@dhm.mhn.de

Locations

Austria
Wilhelminenspital Wien	Recruiting
Wien, Austria, 1160
Contact: Kurt Huber, MD kurt.huber@meduniwien.ac.at
Principal Investigator: Kurt Huber, MD
Krankenanstalt Rudolfstiftung	Recruiting
Wien, Austria, 1030
Contact: Franz Weidinger, MD franz.weidinger@wienkav.at
Principal Investigator: Franz Weidinger, MD
Belgium
University Hospitals Leuven	Recruiting
Leuven, Belgium, 3000
Contact: Tom Adriaenssens, MD tadriaenssens@hotmail.com
Principal Investigator: Tom Adriaenssens, MD
China
Shenyang Northern Hospital	Recruiting
Shenyang, China, 110016
Contact: Yaling Han, MD hanyaling.nh@gmail.com
Principal Investigator: Yaling Han, MD
Germany
Herzzentrum Bad Krozingen	Recruiting
Bad Krozingen, Germany, 79189
Contact: Franz-Josef Neumann, MD
Principal Investigator: Franz-Josef Neumann, MD
Segeberger Kliniken GmbH	Recruiting
Bad Segeberg, Germany, 23795
Contact: Gerd Richardt, MD
Principal Investigator: Gerd Richardt, MD
Technische Universität Dresden	Not yet recruiting
Dresden, Germany, 01309
Contact: Ruth H. Strasser, MD Ruth.Strasser@tu-dresden.de
Principal Investigator: Ruth H. Strasser, MD
Universitätsklinikum Erlangen	Not yet recruiting
Erlangen, Germany, 91054
Contact: Werner G. Daniel, MD Werner.Daniel@uk-erlangen.de
Principal Investigator: Werner G. Daniel, MD
Klinikum Garmisch-Partenkirchen	Recruiting
Garmisch-Partenkirchen, Germany, 82467
Contact: Franz Dotzer, MD Franz.Dotzer@klinikum-gap.de
Principal Investigator: Franz Dotzer, MD
Universitätsmedizin Göttingen	Not yet recruiting
Göttingen, Germany, 37075
Contact: Claudius Jacobshagen, MD jacobshagen@med.uni-goettingen.de
Principal Investigator: Claudius Jacobshagen, MD
Krankenhaus Landshut-Achdorf	Not yet recruiting
Landshut, Germany, 84036
Contact: Bernhard Zrenner, MD bernhard.zrenner@kh-landshut-achdorf.de
Principal Investigator: Bernhard Zrenner, MD
Herzzentrum Leipzig	Not yet recruiting
Leipzig, Germany, 04289
Contact: Holger Thiele, MD thielh@medizin.uni-leipzig.de
Principal Investigator: Holger Thiele, MD
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
Städtisches Klinikum München-Neuperlach	Recruiting
München, Germany, 81737
Contact: Harald Mudra, MD harald.mudra@klinikum-muenchen.de
Principal Investigator: Harald Mudra, MD
Lukaskrankenhaus GmbH, Städtische Kliniken Neuss	Not yet recruiting
Neuss, Germany, 41464
Contact: Michael Haude, MD mhaude@lukasneuss.de
Principal Investigator: Michael Haude, MD
Universitätsklinikum Regensburg	Not yet recruiting
Regensburg, Germany, 93042
Contact: Christian Hengstenberg, MD Christian.Hengstenberg@klinik.uni-regensburg.de
Principal Investigator: Christian Hengstenberg, MD
Universitätsklinik Rostock	Recruiting
Rostock, Germany, 18057
Contact: Christoph A. Nienaber, MD christoph.nienaber@med.uni-rostock.de
Principal Investigator: Christoph A. Nienaber, MD
Universitätsklinikum Ulm	Not yet recruiting
Ulm, Germany, 89081
Contact: Jochen Wöhrle, MD jochen.woehrle@uniklinik-ulm.de
Principal Investigator: Jochen Wöhrle, 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
Japan
Kyoto University Hospital	Recruiting
Kyoto, Japan, 606-8507
Contact: Takeshi Kimura, MD taketaka@kuhp.kyoto-u.ac.jp
Principal Investigator: Takeshi Kimura, MD
Netherlands
Catharina Hospital Eindhoven	Recruiting
Eindhoven, Netherlands, 5623
Contact: Jacques J. Koolen, MD jacques.j.koolen@catharina-ziekenhuis.nl
Principal Investigator: Jacques J. Koolen, MD
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
Isala klinieken, locatie Weezenlanden	Recruiting
Zwolle, Netherlands, 8011
Contact: Arnoud van't Hof, MD a.w.j.vant.hof@isala.nl
Principal Investigator: Arnoud van't Hof, MD
New Zealand
Auckland City Hospital	Not yet recruiting
Auckland, New Zealand, 1023
Contact: Mark Webster, MD MWebster@adhb.govt.nz
Principal Investigator: Mark Webster
Switzerland
Inselspital, Universitätsspital Bern	Not yet recruiting
Bern, Switzerland, 3010
Contact: Stephan Windecker, MD stephan.windecker@insel.ch
Principal Investigator: Stephan Windecker, 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
ClinicalTrials.gov Identifier:	NCT00661206 History of Changes
Other Study ID Numbers:	GE IDE No. A01207
Study First Received:	April 15, 2008
Last Updated:	January 3, 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 February 12, 2012