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

NCT ID: NCT00661206

Last Updated: 2014-10-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 4005 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2014-11-30

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Clopidogrel

Group Type: ACTIVE_COMPARATOR

Clopidogrel

Intervention Type: DRUG

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Patients randomized in this group will receive placebo for 6 months.

Interventions

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

Intervention Type: DRUG

Placebo

Patients randomized in this group will receive placebo for 6 months.

Intervention Type: DRUG

Other Intervention Names

Plavix; ACT-Code: B01AC/04

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adnan Kastrati, MD

Role: STUDY_CHAIR

Deutsches Herzzentrum Muenchen

Adnan Kastrati, MD

Role: PRINCIPAL_INVESTIGATOR

Deutsches Herzzentrum Muenchen

Jurriёn M ten Berg, MD

Role: PRINCIPAL_INVESTIGATOR

St. Antonius Hospital Nieuwegein, Department of Cardiology

Locations

University of Florida, Health Science Center - Jacksonville

Jacksonville, Florida, United States

Spitali Gjerman

Tirana, , Albania

Krankenanstalt Rudolfstiftung

Vienna, , Austria

Wilhelminenspital Wien

Vienna, , Austria

University Hospitals Leuven

Leuven, , Belgium

Shenyang Northern Hospital

Shenyang, , China

Aarhus University Hospital

Aarhus, , Denmark

Herzzentrum Bad Krozingen

Bad Krozingen, , Germany

Segeberger Kliniken GmbH

Bad Segeberg, , Germany

Charité Berlin, Campus Benjamin Franklin

Berlin, , Germany

Technische Universität Dresden

Dresden, , Germany

Universitätsklinikum Erlangen

Erlangen, , Germany

Klinikum Garmisch-Partenkirchen

Garmisch-Partenkirchen, , Germany

Universitätsmedizin Göttingen

Göttingen, , Germany

Klinikum Ingolstadt

Ingolstadt, , Germany

MediClin Herzzentrum Lahr/Baden

Lahr, , Germany

Krankenhaus Landshut-Achdorf

Landshut, , Germany

Herzzentrum Leipzig

Leipzig, , Germany

Universitätsklinikum Schleswig-Holstein, Campus Lübeck

Lübeck, , Germany

Deutsches Herzzentrum München

Munich, , Germany

1st Medizinische Klinik, Klinikum rechts der Isar

Munich, , Germany

Klinikum Bogenhausen

Munich, , Germany

Klinikum München-Großhadern

München, , Germany

Städtisches Klinikum München-Neuperlach

München, , Germany

Lukaskrankenhaus GmbH, Städtische Kliniken Neuss

Neuss, , Germany

Universitätsklinikum Regensburg

Regensburg, , Germany

Klinikum Barmherzige Brüder Regensburg

Regensburg, , Germany

Universitätsklinik Rostock

Rostock, , Germany

Universitätsklinikum Ulm

Ulm, , Germany

HELIOS Klinikum Wuppertal-Herzzentrum

Wuppertal, , Germany

University College Hospital Galway

Galway, , Ireland

Campus Biomedico University of Rome

Rome, , Italy

Tokai University School of Medicine

Isehara, , Japan

Kyoto University Hospital

Kyoto, , Japan

Catharina Hospital Eindhoven

Eindhoven, , Netherlands

St. Antonius Hospital Department of Cardiology

Nieuwegein, , Netherlands

Maasstad Ziekenhuis

Rotterdam, , Netherlands

Isala klinieken, locatie Weezenlanden

Zwolle, , Netherlands

Auckland City Hospital

Auckland, , New Zealand

Inselspital, Universitätsspital Bern

Bern, , Switzerland

Countries

United States; Albania; Austria; Belgium; China; Denmark; Germany; Ireland; Italy; Japan; Netherlands; New Zealand; Switzerland

References

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.

Reference Type: DERIVED

PMID: 25616646 (View on PubMed)

Other Identifiers

GE IDE No. A01207

Identifier Type: -

Identifier Source: org_study_id