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Abrupt Versus Tapered Interruption of Chronic Clopidogrel Therapy After DES Implantation (ISAR-CAUTION)

Primary Purpose

Coronary Artery Disease

Status
Terminated
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Abrupt Clopidogrel Interruption
Clopidogrel Tapering
Sponsored by
Deutsches Herzzentrum Muenchen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Clopidogrel, Drug-eluting Stent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Deutsches Herzzentrum Muenchen
  • Medizinische Klinik, Klinikum rechts der Isar

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Clopidogrel Tapering

Abrupt Clopidogrel Interruption

Arm Description

Outcomes

Primary Outcome Measures

Composite of cardiac death, myocardial infarction, stent thrombosis, stroke, major bleeding or rehospitalization due to acute coronary syndrome.

Secondary Outcome Measures

The individual components of the primary endpoint. All cause mortality.

Full Information

First Posted
March 17, 2008
Last Updated
July 26, 2016
Sponsor
Deutsches Herzzentrum Muenchen
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1. Study Identification

Unique Protocol Identification Number
NCT00640679
Brief Title
Abrupt Versus Tapered Interruption of Chronic Clopidogrel Therapy After DES Implantation
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Terminated
Why Stopped
Due to slow enrollment the study was stopped prematurely.
Study Start Date
April 2008 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Deutsches Herzzentrum Muenchen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Clopidogrel, Drug-eluting Stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
782 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clopidogrel Tapering
Arm Type
Active Comparator
Arm Title
Abrupt Clopidogrel Interruption
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Abrupt Clopidogrel Interruption
Other Intervention Name(s)
Plavix
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Clopidogrel Tapering
Other Intervention Name(s)
Plavix
Intervention Description
Patients assigned to this group will have Clopidogrel gradually decreased according to a fixed tapering schema of Clopidogrel and Placebo over 4 weeks.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
The individual components of the primary endpoint. All cause mortality.
Time Frame
3 months after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adnan Kastrati, MD
Organizational Affiliation
Deutsches Herzzentrum Muenchen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Julinda Mehilli, MD
Organizational Affiliation
Deutsches Herzzentrum Muenchen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deutsches Herzzentrum Muenchen
City
Munich
ZIP/Postal Code
80636
Country
Germany
Facility Name
Medizinische Klinik, Klinikum rechts der Isar
City
Munich
ZIP/Postal Code
81675
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
24633406
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.
Results Reference
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Abrupt Versus Tapered Interruption of Chronic Clopidogrel Therapy After DES Implantation

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