Abrupt Versus Tapered Interruption of Chronic Clopidogrel Therapy After DES Implantation (ISAR-CAUTION)

German Heart Center Munich

Status and phase

Terminated

Phase 4

Conditions

Coronary Artery Disease

Treatments

Drug: Clopidogrel Tapering

Drug: Abrupt Clopidogrel Interruption

Study type

Interventional

Funder types

Other

Identifiers

NCT00640679

GE IDE No. A01308

Details and patient eligibility

About

The hypothesis to be tested is that gradual clopidogrel therapy cessation is associated with a superior clinical outcome compared with abrupt cessation (superiority hypothesis).

Full 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.

Enrollment

782 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.