A Phase 4 interventional study of Abrupt Clopidogrel Interruption and Clopidogrel Tapering in Coronary Artery Disease, sponsored by Deutsches Herzzentrum Muenchen. Terminated at 2 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-27.
Sponsored by Deutsches Herzzentrum Muenchen · Phase 4, Interventional, and Treatment
The hypothesis to be tested is that gradual clopidogrel therapy cessation is associated with a superior clinical outcome compared with abrupt cessation (superiority hypothesis).
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 782 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Deutsches Herzzentrum Muenchen is the lead sponsor of 112 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Drug: Clopidogrel Tapering
Drug: Abrupt Clopidogrel Interruption
Patients assigned to this group will receive Clopidogrel 75mg per day for an additional period of 4 weeks. Afterwards they will stop the drug abruptly.
Also known as: Plavix
Patients assigned to this group will have Clopidogrel gradually decreased according to a fixed tapering schema of Clopidogrel and Placebo over 4 weeks.
Also known as: Plavix
Composite of cardiac death, myocardial infarction, stent thrombosis, stroke, major bleeding or rehospitalization due to acute coronary syndrome.
Time frame: 3 months after randomization
The individual components of the primary endpoint. All cause mortality.
Time frame: 3 months after randomization
This study is terminated, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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Deutsches Herzzentrum Muenchen