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

NCT00661206 | Unknown Phase 4 DMC

• 1 other identifier: GE IDE No. A01207
• Study Type: interventional
• Target: 4,005
• Locations: 13 countries
• Sites: 40

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.

Conditions

Coronary Artery Disease

Keywords

Clopidogrel; Drug-eluting stent

Outcome Measures

Primary Outcomes (1)

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

  9 months after randomization

Secondary Outcomes (1)

• The individual components of the primary endpoint

  9 months after randomization

Study Arms (2)

Clopidogrel

ACTIVE COMPARATOR

Drug: Clopidogrel

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Clopidogrel 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

Also known as: Plavix, ACT-Code: B01AC/04

Clopidogrel

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients on clopidogrel therapy at 6 months (-1/+2 months) after DES implantation
• Informed, written consent by the patient

You may not qualify if:

• 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.

Sponsors & Collaborators

• Deutsches Herzzentrum Muenchen: lead

Study Sites (40)

University of Florida, Health Science Center - Jacksonville

Jacksonville, Florida, 32209, United States

Location

Spitali Gjerman

Tirana, Albania

Location

Krankenanstalt Rudolfstiftung

Vienna, 1030, Austria

Location

Wilhelminenspital Wien

Vienna, 1160, Austria

Location

University Hospitals Leuven

Leuven, 3000, Belgium

Location

Shenyang Northern Hospital

Shenyang, 110016, China

Location

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Herzzentrum Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Segeberger Kliniken GmbH

Bad Segeberg, 23795, Germany

Location

Charité Berlin, Campus Benjamin Franklin

Berlin, 12203, Germany

Location

Technische Universität Dresden

Dresden, 01309, Germany

Location

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

Location

Klinikum Garmisch-Partenkirchen

Garmisch-Partenkirchen, 82467, Germany

Location

Universitätsmedizin Göttingen

Göttingen, 37075, Germany

Location

Klinikum Ingolstadt

Ingolstadt, 85049, Germany

Location

MediClin Herzzentrum Lahr/Baden

Lahr, 77933, Germany

Location

Krankenhaus Landshut-Achdorf

Landshut, 84036, Germany

Location

Herzzentrum Leipzig

Leipzig, 04289, Germany

Location

Universitätsklinikum Schleswig-Holstein, Campus Lübeck

Lübeck, 23538, Germany

Location

Deutsches Herzzentrum München

Munich, 81541, Germany

Location

1st Medizinische Klinik, Klinikum rechts der Isar

Munich, 81675, Germany

Location

Klinikum Bogenhausen

Munich, 81925, Germany

Location

Klinikum München-Großhadern

München, 81377, Germany

Location

Städtisches Klinikum München-Neuperlach

München, 81737, Germany

Location

Lukaskrankenhaus GmbH, Städtische Kliniken Neuss

Neuss, 41464, Germany

Location

Universitätsklinikum Regensburg

Regensburg, 93042, Germany

Location

Klinikum Barmherzige Brüder Regensburg

Regensburg, 93049, Germany

Location

Universitätsklinik Rostock

Rostock, 18057, Germany

Location

Universitätsklinikum Ulm

Ulm, 89081, Germany

Location

HELIOS Klinikum Wuppertal-Herzzentrum

Wuppertal, 42117, Germany

Location

University College Hospital Galway

Galway, Ireland

Location

Campus Biomedico University of Rome

Rome, 00128, Italy

Location

Tokai University School of Medicine

Isehara, 259 - 1193, Japan

Location

Kyoto University Hospital

Kyoto, 606-8507, Japan

Location

Catharina Hospital Eindhoven

Eindhoven, 5623, Netherlands

Location

St. Antonius Hospital Department of Cardiology

Nieuwegein, 3435, Netherlands

Location

Maasstad Ziekenhuis

Rotterdam, 3075, Netherlands

Location

Isala klinieken, locatie Weezenlanden

Zwolle, 8011, Netherlands

Location

Auckland City Hospital

Auckland, 1023, New Zealand

Location

Inselspital, Universitätsspital Bern

Bern, 3010, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 25616646 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Adnan Kastrati, MD

  Deutsches Herzzentrum Muenchen

  STUDY CHAIR

• Adnan Kastrati, MD

  Deutsches Herzzentrum Muenchen

  PRINCIPAL INVESTIGATOR

• Jurriёn M ten Berg, MD

  St. Antonius Hospital Nieuwegein, Department of Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2008
• First Posted: April 18, 2008
• Study Start: September 1, 2008
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: October 9, 2014

Record last verified: 2014-10

Locations

AL (1); AU (2); BE (1); CN (1); IT (1); NL (4); JP (2); US (1); DE (23); NZ (1); CH (1); IE (1); DK (1)