Clinical trial NCT00661206: Safety and Efficacy of Six Months Dual Antiplatelet Therapy After Drug-Eluting Stenting
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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Clopidogrel
Drug-eluting stent
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2008-04-18
Enrollment: 4005
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Composite of death, myocardial infarction, stent thrombosis, stroke or TIMI major bleeding.
timeFrame: 9 months after randomization
Secondary outcomes:
measure: The individual components of the primary endpoint
timeFrame: 9 months after randomization
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida, Health Science Center - Jacksonville
state: Florida
city: Tirana
country: Albania
facility: Spitali Gjerman
city: Wien
country: Austria
facility: Krankenanstalt Rudolfstiftung
city: Wien
country: Austria
facility: Wilhelminenspital Wien
city: Leuven
country: Belgium
facility: University Hospitals Leuven
city: Shenyang
country: China
facility: Shenyang Northern Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Bad Krozingen
country: Germany
facility: Herzzentrum Bad Krozingen
city: Bad Segeberg
country: Germany
facility: Segeberger Kliniken GmbH
city: Berlin
country: Germany
facility: Charité Berlin, Campus Benjamin Franklin
city: Dresden
country: Germany
facility: Technische Universität Dresden
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Garmisch-Partenkirchen
country: Germany
facility: Klinikum Garmisch-Partenkirchen
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen
city: Ingolstadt
country: Germany
facility: Klinikum Ingolstadt
city: Lahr
country: Germany
facility: MediClin Herzzentrum Lahr/Baden
city: Landshut
country: Germany
facility: Krankenhaus Landshut-Achdorf
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Lübeck
city: Munich
country: Germany
facility: Deutsches Herzzentrum München
city: Munich
country: Germany
facility: 1st Medizinische Klinik, Klinikum rechts der Isar
city: Munich
country: Germany
facility: Klinikum Bogenhausen
city: München
country: Germany
facility: Klinikum München-Großhadern
city: München
country: Germany
facility: Städtisches Klinikum München-Neuperlach
city: Neuss
country: Germany
facility: Lukaskrankenhaus GmbH, Städtische Kliniken Neuss
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
city: Regensburg
country: Germany
facility: Klinikum Barmherzige Brüder Regensburg
city: Rostock
country: Germany
facility: Universitätsklinik Rostock
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Wuppertal
country: Germany
facility: HELIOS Klinikum Wuppertal-Herzzentrum
city: Galway
country: Ireland
facility: University College Hospital Galway
city: Rome
country: Italy
facility: Campus Biomedico University of Rome
city: Isehara
country: Japan
facility: Tokai University School of Medicine
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Eindhoven
country: Netherlands
facility: Catharina Hospital Eindhoven
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital Department of Cardiology
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
city: Zwolle
country: Netherlands
facility: Isala klinieken, locatie Weezenlanden
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Bern
country: Switzerland
facility: Inselspital, Universitätsspital Bern
Study officials:
affiliation: Deutsches Herzzentrum Muenchen
name: Adnan Kastrati, MD
role: STUDY_CHAIR
affiliation: Deutsches Herzzentrum Muenchen
name: Adnan Kastrati, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Antonius Hospital Nieuwegein, Department of Cardiology
name: Jurriёn M ten Berg, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.