Abrupt Versus Tapered Interruption of Chronic Clopidogrel Therapy After DES Implantation

Prospective, Randomized, Double-Blind Trial of Abrupt and Tapered Interruption of Long-term Clopidogrel Therapy After Implantation of a Drug-Eluting Stent

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.

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.