This trial is active, not recruiting.

Condition coronary artery disease
Treatments abrupt clopidogrel interruption, clopidogrel tapering
Phase phase 4
Sponsor Deutsches Herzzentrum Muenchen
Start date April 2008
End date June 2012
Trial size 3000 participants
Trial identifier NCT00640679, GE IDE No. A01308


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
clopidogrel tapering Plavix
Patients assigned to this group will have Clopidogrel gradually decreased according to a fixed tapering schema of Clopidogrel and Placebo over 4 weeks.
(Active Comparator)
abrupt clopidogrel interruption Plavix
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.

Primary Outcomes

Composite of cardiac death, myocardial infarction, stent thrombosis, stroke, major bleeding or rehospitalization due to acute coronary syndrome.
time frame: 3 months after randomization

Secondary Outcomes

The individual components of the primary endpoint. All cause mortality.
time frame: 3 months after randomization

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Prospective, Randomized, Double-Blind Trial of Abrupt and Tapered Interruption of Long-term Clopidogrel Therapy After Implantation of a Drug-Eluting Stent
Principal investigator Julinda Mehilli, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2012.
Information provided to ClinicalTrials.gov by Deutsches Herzzentrum Muenchen.