Clinical trial NCT00640679: Abrupt Versus Tapered Interruption of Chronic Clopidogrel Therapy After DES Implantation
Official title: Prospective, Randomized, Double-Blind Trial of Abrupt and Tapered Interruption of Long-term Clopidogrel Therapy After Implantation of a Drug-Eluting Stent
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Clopidogrel
Drug-eluting Stent
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2008-03-21
Enrollment: 782
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Composite of cardiac death, myocardial infarction, stent thrombosis, stroke, major bleeding or rehospitalization due to acute coronary syndrome.
timeFrame: 3 months after randomization
Secondary outcomes:
measure: The individual components of the primary endpoint. All cause mortality.
timeFrame: 3 months after randomization
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum Muenchen
city: Munich
country: Germany
facility: Medizinische Klinik, Klinikum rechts der Isar
Study officials:
affiliation: Deutsches Herzzentrum Muenchen
name: Adnan Kastrati, MD
role: STUDY_CHAIR
affiliation: Deutsches Herzzentrum Muenchen
name: Julinda Mehilli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fiedler KA, Mehilli J, Kufner S, Schlichting A, Ibrahim T, Sibbing D, Ott I, Schunkert H, Laugwitz KL, Kastrati A, Schulz S. Randomised, double-blind trial on the value of tapered discontinuation of clopidogrel maintenance therapy after drug-eluting stent implantation. Intracoronary Stenting and Antithrombotic Regimen: CAUTION in Discontinuing Clopidogrel Therapy--ISAR-CAUTION. Thromb Haemost. 2014 Jun;111(6):1041-9. doi: 10.1160/TH13-11-0900. Epub 2014 Mar 13.