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

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Clopidogrel
Placebo
Sponsored by
Deutsches Herzzentrum Muenchen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Clopidogrel, Drug-eluting stent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Florida, Health Science Center - Jacksonville
  • Spitali Gjerman
  • Krankenanstalt Rudolfstiftung
  • Wilhelminenspital Wien
  • University Hospitals Leuven
  • Shenyang Northern Hospital
  • Aarhus University Hospital
  • Herzzentrum Bad Krozingen
  • Segeberger Kliniken GmbH
  • Charité Berlin, Campus Benjamin Franklin
  • Technische Universität Dresden
  • Universitätsklinikum Erlangen
  • Klinikum Garmisch-Partenkirchen
  • Universitätsmedizin Göttingen
  • Klinikum Ingolstadt
  • MediClin Herzzentrum Lahr/Baden
  • Krankenhaus Landshut-Achdorf
  • Herzzentrum Leipzig
  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck
  • Deutsches Herzzentrum München
  • 1st Medizinische Klinik, Klinikum rechts der Isar
  • Klinikum Bogenhausen
  • Klinikum München-Großhadern
  • Städtisches Klinikum München-Neuperlach
  • Lukaskrankenhaus GmbH, Städtische Kliniken Neuss
  • Universitätsklinikum Regensburg
  • Klinikum Barmherzige Brüder Regensburg
  • Universitätsklinik Rostock
  • Universitätsklinikum Ulm
  • HELIOS Klinikum Wuppertal-Herzzentrum
  • University College Hospital Galway
  • Campus Biomedico University of Rome
  • Tokai University School of Medicine
  • Kyoto University Hospital
  • Catharina Hospital Eindhoven
  • St. Antonius Hospital Department of Cardiology
  • Maasstad Ziekenhuis
  • Isala klinieken, locatie Weezenlanden
  • Auckland City Hospital
  • Inselspital, Universitätsspital Bern

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Clopidogrel

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Composite of death, myocardial infarction, stent thrombosis, stroke or TIMI major bleeding.

Secondary Outcome Measures

The individual components of the primary endpoint

Full Information

First Posted
April 15, 2008
Last Updated
October 8, 2014
Sponsor
Deutsches Herzzentrum Muenchen
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1. Study Identification

Unique Protocol Identification Number
NCT00661206
Brief Title
Safety and Efficacy of Six Months Dual Antiplatelet Therapy After Drug-Eluting Stenting
Acronym
ISAR-SAFE
Official Title
Randomized, Double-Blind, Placebo-controlled Trial of 6 vs. 12 Months Clopidogrel Therapy After Implantation of a Drug-Eluting Stent
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
November 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Deutsches Herzzentrum Muenchen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Clopidogrel, Drug-eluting stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4005 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clopidogrel
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Other Intervention Name(s)
Plavix, ACT-Code: B01AC/04
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients randomized in this group will receive placebo for 6 months.
Primary Outcome Measure Information:
Title
Composite of death, myocardial infarction, stent thrombosis, stroke or TIMI major bleeding.
Time Frame
9 months after randomization
Secondary Outcome Measure Information:
Title
The individual components of the primary endpoint
Time Frame
9 months after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adnan Kastrati, MD
Organizational Affiliation
Deutsches Herzzentrum Muenchen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Adnan Kastrati, MD
Organizational Affiliation
Deutsches Herzzentrum Muenchen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jurriёn M ten Berg, MD
Organizational Affiliation
St. Antonius Hospital Nieuwegein, Department of Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida, Health Science Center - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Spitali Gjerman
City
Tirana
Country
Albania
Facility Name
Krankenanstalt Rudolfstiftung
City
Wien
ZIP/Postal Code
1030
Country
Austria
Facility Name
Wilhelminenspital Wien
City
Wien
ZIP/Postal Code
1160
Country
Austria
Facility Name
University Hospitals Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Shenyang Northern Hospital
City
Shenyang
ZIP/Postal Code
110016
Country
China
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Herzzentrum Bad Krozingen
City
Bad Krozingen
ZIP/Postal Code
79189
Country
Germany
Facility Name
Segeberger Kliniken GmbH
City
Bad Segeberg
ZIP/Postal Code
23795
Country
Germany
Facility Name
Charité Berlin, Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Technische Universität Dresden
City
Dresden
ZIP/Postal Code
01309
Country
Germany
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Klinikum Garmisch-Partenkirchen
City
Garmisch-Partenkirchen
ZIP/Postal Code
82467
Country
Germany
Facility Name
Universitätsmedizin Göttingen
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Klinikum Ingolstadt
City
Ingolstadt
ZIP/Postal Code
85049
Country
Germany
Facility Name
MediClin Herzzentrum Lahr/Baden
City
Lahr
ZIP/Postal Code
77933
Country
Germany
Facility Name
Krankenhaus Landshut-Achdorf
City
Landshut
ZIP/Postal Code
84036
Country
Germany
Facility Name
Herzzentrum Leipzig
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Deutsches Herzzentrum München
City
Munich
ZIP/Postal Code
81541
Country
Germany
Facility Name
1st Medizinische Klinik, Klinikum rechts der Isar
City
Munich
ZIP/Postal Code
81675
Country
Germany
Facility Name
Klinikum Bogenhausen
City
Munich
ZIP/Postal Code
81925
Country
Germany
Facility Name
Klinikum München-Großhadern
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Städtisches Klinikum München-Neuperlach
City
München
ZIP/Postal Code
81737
Country
Germany
Facility Name
Lukaskrankenhaus GmbH, Städtische Kliniken Neuss
City
Neuss
ZIP/Postal Code
41464
Country
Germany
Facility Name
Universitätsklinikum Regensburg
City
Regensburg
ZIP/Postal Code
93042
Country
Germany
Facility Name
Klinikum Barmherzige Brüder Regensburg
City
Regensburg
ZIP/Postal Code
93049
Country
Germany
Facility Name
Universitätsklinik Rostock
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
HELIOS Klinikum Wuppertal-Herzzentrum
City
Wuppertal
ZIP/Postal Code
42117
Country
Germany
Facility Name
University College Hospital Galway
City
Galway
Country
Ireland
Facility Name
Campus Biomedico University of Rome
City
Rome
ZIP/Postal Code
00128
Country
Italy
Facility Name
Tokai University School of Medicine
City
Isehara
ZIP/Postal Code
259 - 1193
Country
Japan
Facility Name
Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Catharina Hospital Eindhoven
City
Eindhoven
ZIP/Postal Code
5623
Country
Netherlands
Facility Name
St. Antonius Hospital Department of Cardiology
City
Nieuwegein
ZIP/Postal Code
3435
Country
Netherlands
Facility Name
Maasstad Ziekenhuis
City
Rotterdam
ZIP/Postal Code
3075
Country
Netherlands
Facility Name
Isala klinieken, locatie Weezenlanden
City
Zwolle
ZIP/Postal Code
8011
Country
Netherlands
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Inselspital, Universitätsspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
25616646
Citation
Schulz-Schupke S, Byrne RA, Ten Berg JM, Neumann FJ, Han Y, Adriaenssens T, Tolg R, Seyfarth M, Maeng M, Zrenner B, Jacobshagen C, Mudra H, von Hodenberg E, Wohrle J, Angiolillo DJ, von Merzljak B, Rifatov N, Kufner S, Morath T, Feuchtenberger A, Ibrahim T, Janssen PW, Valina C, Li Y, Desmet W, Abdel-Wahab M, Tiroch K, Hengstenberg C, Bernlochner I, Fischer M, Schunkert H, Laugwitz KL, Schomig A, Mehilli J, Kastrati A; Intracoronary Stenting and Antithrombotic Regimen: Safety And EFficacy of 6 Months Dual Antiplatelet Therapy After Drug-Eluting Stenting (ISAR-SAFE) Trial Investigators. ISAR-SAFE: a randomized, double-blind, placebo-controlled trial of 6 vs. 12 months of clopidogrel therapy after drug-eluting stenting. Eur Heart J. 2015 May 21;36(20):1252-63. doi: 10.1093/eurheartj/ehu523. Epub 2015 Jan 23.
Results Reference
derived

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

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