Abrupt Versus Tapered Interruption of Chronic Clopidogrel Therapy After DES Implantation

Phase 4

Terminated

• Conditions: Coronary Artery Disease
• Interventions: Drug: Abrupt Clopidogrel Interruption; Drug: Clopidogrel Tapering

• Registration Number: NCT00640679
• Lead Sponsor: Deutsches Herzzentrum Muenchen

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.

Study Timeline

• Study First Submitted: 2008-03-17
• Study First Submitted QC: 2008-03-20
• Study First Posted: 2008-03-21
• Study Start: 2008-04
• Status Verified: 2012-06
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Last Update Submitted: 2016-07-26
• Last Update Posted: 2016-07-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 782

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Abrupt Clopidogrel Interruption	Abrupt Clopidogrel Interruption	-
Clopidogrel Tapering	Clopidogrel Tapering	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The individual components of the primary endpoint. All cause mortality.	3 months after randomization

Trial Locations

Locations (2)

Medizinische Klinik, Klinikum rechts der Isar; 🇩🇪 Munich, Germany

Deutsches Herzzentrum Muenchen; 🇩🇪 Munich, Germany