Abrupt Versus Tapered Interruption of Chronic Clopidogrel Therapy After DES Implantation

Coronary Artery Disease Clinical Trial

— ISAR-CAUTION  

Official title:

Prospective, Randomized, Double-Blind Trial of Abrupt and Tapered Interruption of Long-term Clopidogrel Therapy After Implantation of a Drug-Eluting Stent

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00640679
• Other study ID #: GE IDE No. A01308
• Status: Terminated
• Phase: Phase 4
• First received: March 17, 2008
• Last updated: July 26, 2016
• Start date: April 2008
• Est. completion date: August 2012

Study information

• Verified date: June 2012
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 782
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum Muenchen	Munich
Germany	Medizinische Klinik, Klinikum rechts der Isar	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of cardiac death, myocardial infarction, stent thrombosis, stroke, major bleeding or rehospitalization due to acute coronary syndrome.		3 months after randomization	Yes
Secondary	The individual components of the primary endpoint. All cause mortality.		3 months after randomization	Yes