Status:
UNKNOWN
Safety and Efficacy of Six Months Dual Antiplatelet Therapy After Drug-Eluting Stenting
Lead Sponsor:
Deutsches Herzzentrum Muenchen
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 antiplat...
Eligibility Criteria
Inclusion
- Patients on clopidogrel therapy at 6 months (-1/+2 months) after DES implantation
- Informed, written consent by the patient
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
4005 Patients enrolled
Trial Details
Trial ID
NCT00661206
Start Date
September 1 2008
End Date
November 1 2014
Last Update
October 9 2014
Active Locations (40)
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1
University of Florida, Health Science Center - Jacksonville
Jacksonville, Florida, United States, 32209
2
Spitali Gjerman
Tirana, Albania
3
Krankenanstalt Rudolfstiftung
Vienna, Austria, 1030
4
Wilhelminenspital Wien
Vienna, Austria, 1160