RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF 6 MONTHS VERSUS 12 MONTHS CLOPIDOGREL THERAPY AFTER IMPLANTATION OF A DRUG-ELUTING STENT SAFETY AND EFFICACY OF SIX MONTHS DUAL ANTIPLATELET THERAPY AFTER DRUG-ELUTING STENTING – ISAR-SAFE - ISAR-SAFE

Phase 1

• Conditions: Patients with established coronary artery disease on chronic clopidogrel therapy at 6 months after coronary drug eluting stent implantation.; MedDRA version: 14.1Level: PTClassification code 10011078Term: Coronary artery diseaseSystem Organ Class: 10007541 - Cardiac disorders

• Registration Number: EUCTR2007-006263-68-DK
• Lead Sponsor: Deutsches Herzzentrum Muenchen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-18
• Last Update Posted: 3 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 6000

Inclusion Criteria

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Age =18 years
2.Clinically symptoms, proof of ischemia and/or presence of angiographic lesions requiring revascularization
3.Previous stent thrombosis
4.DES in left main coronary artery
5.STEMI and NSTEMI during the last 6 months
6.Malignancies or other comorbid conditions with a life expectancy of less than one year or that may result in protocol noncompliance
7.Planned major surgery within the next 6 months with the need to discontinue antiplatelet therapy
8.Active bleeding; bleeding diathesis; history intracranial bleeding
9.Oral anticoagulation therapy with coumadin derivatives
10.Known allergy or intolerance to the study medications: aspirin and clopidogrel
11. Pregnancy (present, suspected or planned) or positive pregnancy test
(In women with childbearing potential a negative pregnancy test is mandatory)
12.Patient’s inability to fully comply with the study protocol
13.Prior enrollment in the same clinical trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The hypothesis to be tested is that a clopidogrel therapy duration of 6 months after coronary drug-eluting stent implantation is associated with a clinical outcome that is not inferior to that of a 12-month therapy.<br>The primary end point of the study is a composite of death, myocardial infarction, stent thrombosis (definite or probable according to Academic Research Consortium [ARC] criteria), stroke or TIMI major bleeding. ;Secondary Objective: The secondary endpoint contains the individual components of the primary endpoint.<br>;Primary end point(s): The hypothesis to be tested is that a clopidogrel therapy duration of 6 months after DES implantation is associated with a clinical outcome that is not inferior to that of a 12-month therapy. The primary end point of the study is a composite of death, myocardial infarction, stent thrombosis (definite or probable according to Academic Research Consortium [ARC] criteria), stroke or TIMI major bleeding.