Randomized, Double-Blind, Placebo-Controlled Trial of 6 Months versus 12 Months Clopidogrel Therapy After Implantation Of A Drug-Eluting Stent Intracoronary Stenting and Antithrombotic Regimen:Safety And Efficacy of Six-Months Dual Antiplatelet Therapy After Drug-Eluting Stenting

Phase 4

Recruiting

Conditions: I20
I21
I22
I23
I24
I25
Angina pectoris
Acute myocardial infarction
Subsequent myocardial infarction
Certain current complications following acute myocardial infarction

Registration Number: DRKS00000132

Lead Sponsor: Klinik für Herz-und KreislauferkrankungenDeutsches Herzzentrum München

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: 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

Exclusion Criteria

1. Age =18 years
2. Clinically symptoms, signs of ischemia and/or presence of angiographic lesions requiring revascularization
3. Previous stent thrombosis
4. DES in left main coronary artery
5. ST-elevation and non ST-elevation myocardial infarction during the last 6 months after DES implantation
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 coumarin derivatives
10. Known allergy or intolerance to the study medications: aspirin and clopidogrel
11. Pregnancy (present, suspected or planned) or positive pregnancy test
12. Patient's inability to fully comply with the study protocol
13. Enrollment in another clinical trial before reaching the primary endpoint

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite of death, myocardial infarction, stent thrombosis, stroke or bleeding during a 9 months follow-up period.

Secondary Outcome Measures

Name	Time	Method
The individual components of the primary endpoint (death, myocardial infarction, stent thrombosis, stroke, TIMI major bleeding) during the 9 months follow-up period