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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00640679
Recruitment Status : Terminated (Due to slow enrollment the study was stopped prematurely.)
First Posted : March 21, 2008
Last Update Posted : July 27, 2016
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Abrupt Clopidogrel Interruption Drug: Clopidogrel Tapering Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 782 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : April 2008
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Clopidogrel Tapering 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.
Other Name: Plavix

Active Comparator: Abrupt Clopidogrel Interruption 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.
Other Name: Plavix

Primary Outcome Measures :
  1. 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 Measures :
  1. The individual components of the primary endpoint. All cause mortality. [ Time Frame: 3 months after randomization ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00640679

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Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
Medizinische Klinik, Klinikum rechts der Isar
Munich, Germany, 81675
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
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Study Chair: Adnan Kastrati, MD Deutsches Herzzentrum Muenchen
Principal Investigator: Julinda Mehilli, MD Deutsches Herzzentrum Muenchen
Publications of Results:
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Responsible Party: Deutsches Herzzentrum Muenchen Identifier: NCT00640679    
Other Study ID Numbers: GE IDE No. A01308
First Posted: March 21, 2008    Key Record Dates
Last Update Posted: July 27, 2016
Last Verified: June 2012
Keywords provided by Deutsches Herzzentrum Muenchen:
Drug-eluting Stent
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs