Status:
TERMINATED
Abrupt Versus Tapered Interruption of Chronic Clopidogrel Therapy After DES Implantation
Lead Sponsor:
Deutsches Herzzentrum Muenchen
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The hypothesis to be tested is that gradual clopidogrel therapy cessation is associated with a superior clinical outcome compared with abrupt cessation (superiority hypothesis).
Detailed Description
A possible rebound in platelet activity after clopidogrel withdrawal has been suggested in patients on chronic clopidogrel therapy. However, a systematic evaluation of the role of rapid thienopyridine...
Eligibility Criteria
Inclusion
- Patients with planned interruption of chronic clopidogrel therapy after DES implantation
- Informed, written consent by the patient
Exclusion
- Planned surgery within the next month
- Active bleeding as reason for clopidogrel discontinuation
- Concomitant coumadin therapy
- Pregnancy (present, suspected or planned) or positive pregnancy test (In women with childbearing potential a negative pregnancy test is mandatory)
- Malignancies or other comorbid conditions with a life expectancy of less than one year or that may result in protocol noncompliance.
- Patient's inability to fully comply with the study protocol.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
782 Patients enrolled
Trial Details
Trial ID
NCT00640679
Start Date
April 1 2008
End Date
August 1 2012
Last Update
July 27 2016
Active Locations (2)
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1
Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
2
Medizinische Klinik, Klinikum rechts der Isar
Munich, Germany, 81675