- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00640679
Abrupt Versus Tapered Interruption of Chronic Clopidogrel Therapy After DES Implantation (ISAR-CAUTION)
July 26, 2016 updated by: Deutsches Herzzentrum Muenchen
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 Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
782
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Munich, Germany, 80636
- Deutsches Herzzentrum Muenchen
-
Munich, Germany, 81675
- Medizinische Klinik, Klinikum rechts der Isar
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
Other Names:
|
Active Comparator: 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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Composite of cardiac death, myocardial infarction, stent thrombosis, stroke, major bleeding or rehospitalization due to acute coronary syndrome.
Time Frame: 3 months after randomization
|
3 months after randomization
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The individual components of the primary endpoint. All cause mortality.
Time Frame: 3 months after randomization
|
3 months after randomization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Adnan Kastrati, MD, Deutsches Herzzentrum Muenchen
- Principal Investigator: Julinda Mehilli, MD, Deutsches Herzzentrum Muenchen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
March 17, 2008
First Submitted That Met QC Criteria
March 20, 2008
First Posted (Estimate)
March 21, 2008
Study Record Updates
Last Update Posted (Estimate)
July 27, 2016
Last Update Submitted That Met QC Criteria
July 26, 2016
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Coronary Artery Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Platelet Aggregation Inhibitors
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Clopidogrel
Other Study ID Numbers
- GE IDE No. A01308
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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