NCT00640679

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 782 (actual)
• Sponsor: Deutsches Herzzentrum Muenchen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
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.
DRUG	Clopidogrel Tapering	Patients assigned to this group will have Clopidogrel gradually decreased according to a fixed tapering schema of Clopidogrel and Placebo over 4 weeks.

Timeline

• Start date: 2008-04-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2008-03-21
• Last updated: 2016-07-27

Locations

2 sites across 1 country: Germany