Abrupt Versus Tapered Interruption of Chronic Clopidogrel Therapy After DES Implantation
Information source: Deutsches Herzzentrum Muenchen
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Artery Disease
Intervention: Abrupt Clopidogrel Interruption (Drug); Clopidogrel Tapering (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Deutsches Herzzentrum Muenchen Official(s) and/or principal investigator(s):
Adnan Kastrati, MD, Study Chair, Affiliation: Deutsches Herzzentrum Muenchen
Julinda Mehilli, MD, Principal Investigator, Affiliation: Deutsches Herzzentrum Muenchen
Overall contact:
Julinda Mehilli, MD, Phone: +49 89 1218, Ext: 4073, Email: mehilli@dhm.mhn.de
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).
Clinical Details
Official title: Prospective, Randomized, Double-Blind Trial of Abrupt and Tapered Interruption of Long-Term Clopidogrel Therapy After Implantation of a Drug-Eluting Stent
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Composite of cardiac death, myocardial infarction, stent thrombosis, stroke, major bleeding or rehospitalization due to acute coronary syndrome.
Secondary outcome: The individual components of the primary endpoint.
All cause mortality.
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 withdrawal on ischemic complications in patients with treated coronary
artery disease has not been addressed by specifically designed studies. The objective of
this study is to evaluate the safety and efficacy of abrupt or tapered interruption of
chronic clopidogrel therapy after intracoronary drug-eluting stent implantation.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with planned interruption of chronic clopidogrel therapy after DES
implantation
- Informed, written consent by the patient
Exclusion Criteria:
- 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.
Locations and Contacts
Julinda Mehilli, MD, Phone: +49 89 1218, Ext: 4073, Email: mehilli@dhm.mhn.de
Deutsches Herzzentrum Muenchen, Munich 80636, Germany; Recruiting
Julinda Mehilli, MD, Email: mehilli@dhm.mhn.de
Julinda Mehilli, MD, Principal Investigator
Medizinische Klinik, Klinikum rechts der Isar, Munich 81675, Germany; Recruiting
Josef Dirschinger, MD, Phone: +49 89 4041, Ext: 2947, Email: dirschinger@med1.med.tum.de
Josef Dirschinger, Principal Investigator
Additional Information
Starting date: April 2008
Ending date: July 2011
Last updated: January 27, 2009
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