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

This study is currently recruiting participants.
Verified April 2012 by Deutsches Herzzentrum Muenchen
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
History of Changes
  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:

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 1534 schulzs@dhm.mhn.de

  Hide Study Locations
Locations
United States, Florida
University of Florida, Health Science Center - Jacksonville Recruiting
Jacksonville, Florida, United States, 32209
Contact: Dominick Angiolillo, MD         dominick.angiolillo@jax.ufl.edu    
Principal Investigator: Dominick Angiolillo, MD            
Albania
Spitali Gjerman Not yet recruiting
Tirana, Albania
Contact: Alban Dibra, MD         a_dibra@yahoo.com    
Principal Investigator: Alban Dibra, MD            
Austria
Wilhelminenspital Wien Recruiting
Wien, Austria, 1160
Contact: Kurt Huber, MD         kurt.huber@meduniwien.ac.at    
Principal Investigator: Kurt Huber, MD            
Krankenanstalt Rudolfstiftung Active, not recruiting
Wien, Austria, 1030
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            
Czech Republic
University Hospital Brno Not yet recruiting
Brno, Czech Republic, 62500
Contact: Petr Kala, MD         pkala@fnbrno.cz    
Principal Investigator: Petr Kala, MD            
Denmark
Aarhus University Hospital Not yet recruiting
Aarhus, Denmark, 8200
Contact: Michael Maeng, MD         michael.maeng@ki.au.dk    
Principal Investigator: Michael Maeng, 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            
Charité Berlin, Campus Benjamin Franklin Recruiting
Berlin, Germany, 12203
Contact: Bernhard Witzenbichler, Prof. Dr.         bernahrd.witzenbichler@carite.de    
Principal Investigator: Bernhard Witzenbichler, MD            
Technische Universität Dresden Recruiting
Dresden, Germany, 01309
Contact: Ruth H. Strasser, MD         Ruth.Strasser@tu-dresden.de    
Principal Investigator: Ruth H. Strasser, MD            
Universitätsklinikum Erlangen 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 Recruiting
Göttingen, Germany, 37075
Contact: Claudius Jacobshagen, MD         jacobshagen@med.uni-goettingen.de    
Principal Investigator: Claudius Jacobshagen, MD            
Klinikum Ingolstadt Recruiting
Ingolstadt, Germany, 85049
Contact: Conrad Pfafferott, MD         conrad.pfafferott@klnikum-ingolstadt.de    
Principal Investigator: Conrad Pfafferott, MD            
MediClin Herzzentrum Lahr/Baden Recruiting
Lahr, Germany, 77933
Contact: Eberhard von Hodenberg, MD         eberhard.vonhodenberg@mediclin.de    
Principal Investigator: Eberhard von Hodenberg, MD            
Krankenhaus Landshut-Achdorf Recruiting
Landshut, Germany, 84036
Contact: Bernhard Zrenner, MD         bernhard.zrenner@kh-landshut-achdorf.de    
Principal Investigator: Bernhard Zrenner, MD            
Herzzentrum Leipzig Active, not recruiting
Leipzig, Germany, 04289
Universitätsklinikum Schleswig-Holstein, Campus Lübeck Recruiting
Lübeck, Germany, 23538
Contact: Heribert Schunkert, MD         heribert.schunkert@uk-sh.de    
Principal Investigator: Heribert Schunkert, MD            
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            
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            
Klinikum Bogenhausen Recruiting
Munich, Germany, 81925
Contact: Martin Schmidt, MD         martin.schmidt@klinlikum-muenchen.de    
Principal Investigator: Martin Schmidt, MD            
Städtisches Klinikum München-Neuperlach Recruiting
München, Germany, 81737
Contact: Harald Mudra, MD         harald.mudra@klinikum-muenchen.de    
Principal Investigator: Harald Mudra, MD            
Klinikum München-Großhadern Recruiting
München, Germany, 81377
Contact: Christian Kupatt, MD         christian.kupatt@med.uni-muenchen.de    
Principal Investigator: Christian Kupatt, MD            
Lukaskrankenhaus GmbH, Städtische Kliniken Neuss Recruiting
Neuss, Germany, 41464
Contact: Michael Haude, MD         mhaude@lukasneuss.de    
Principal Investigator: Michael Haude, MD            
Universitätsklinikum Regensburg Recruiting
Regensburg, Germany, 93042
Contact: Christian Hengstenberg, MD         Christian.Hengstenberg@klinik.uni-regensburg.de    
Principal Investigator: Christian Hengstenberg, MD            
Klinikum Barmherzige Brüder Regensburg Recruiting
Regensburg, Germany, 93049
Contact: Peter Sick, MD         peter.sick@barmherzige-regensburg.de    
Principal Investigator: Peter Sick, 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 Recruiting
Ulm, Germany, 89081
Contact: Jochen Wöhrle, MD         jochen.woehrle@uniklinik-ulm.de    
Principal Investigator: Jochen Wöhrle, MD            
Kreisklinik Wertingen Not yet recruiting
Wertingen, Germany, 86637
Contact: Franz von Hoch, MD         franz.vonhoch@khdw.de    
Principal Investigator: Franz von Hoch, MD            
HELIOS Klinikum Wuppertal-Herzzentrum Recruiting
Wuppertal, Germany, 42117
Contact: Melchior Seyfarth, MD         melchior.seyfarth@helios-kliniken.de    
Principal Investigator: Melchior Seyfarth, MD            
India
Sahara Hospital Not yet recruiting
Lucknow, India, 226010
Contact: Nakul Sinha, MD         sinha.nakul@gmail.com    
Principal Investigator: nakul Sinha, MD            
Ireland
University College Hospital Galway Completed
Galway, Ireland
Italy
Campus Biomedico University of Rome Completed
Rome, Italy, 00128
Japan
Tokai University School of Medicine Completed
Isehara, Japan, 259 - 1193
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 Completed
Eindhoven, Netherlands, 5623
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            
Maasstad Ziekenhuis Recruiting
Rotterdam, Netherlands, 3075
Contact: Elvin Kedhi, MD         ekdhie@maasstadziekenhuis.nl    
Principal Investigator: Elvin Kedhi, MD            
Isala klinieken, locatie Weezenlanden Active, not recruiting
Zwolle, Netherlands, 8011
New Zealand
Auckland City Hospital Recruiting
Auckland, New Zealand, 1023
Contact: Mark Webster, MD         MWebster@adhb.govt.nz    
Principal Investigator: Mark Webster, MD            
Poland
Medical University in Łódź, Bieganski Hospital Not yet recruiting
Lodz, Poland, 91-347
Contact: Jan Peruga, MD         jzperuga@op.pl    
Principal Investigator: Jan Peruga, MD            
Russian Federation
State Scientific Institute for Complex Issues of Cardiovascular Diseases Not yet recruiting
Kemerovo, Russian Federation, 650002
Contact: Vladimir Ganyukov, MD         ganyukov@mail.ru    
Principal Investigator: Vladimir Ganyukov, MD            
Switzerland
Inselspital, Universitätsspital Bern 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: 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 June 18, 2013