Official Title: “Prospective, Randomized, Double-Blind Trial of Abrupt and Tapered Interruption of Long-Term Clopidogrel Therapy After Implantation of a Drug-Eluting Stent”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2011

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.

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Clopidogrel Tapering
• Active Comparator: Abrupt Clopidogrel Interruption

Primary Measures

• Composite of cardiac death, myocardial infarction, stent thrombosis, stroke, major bleeding or rehospitalization due to acute coronary syndrome.
  • Time Frame: 3 months after randomization
    Safety Issue?: Yes

Secondary Measures

• The individual components of the primary endpoint. All cause mortality.
  • Time Frame: 3 months after randomization
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Deutsches Herzzentrum Muenchen

Overall Clinical Trial Officials and Contacts

Adnan Kastrati, MD Study Chair Deutsches Herzzentrum Muenchen  

Overall Contact: Julinda Mehilli, MD +49 89 1218 mehilli@dhm.mhn.de

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00640679

Study ID Number: GE IDE No. A01308

ClinicalTrials.gov Identifier: NCT00640679

Health Authority: Germany: Ethics Commission