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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00640679
First received: March 17, 2008
Last updated: June 11, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention Phase
Coronary Artery Disease
 Drug: Abrupt Clopidogrel Interruption
Drug: Clopidogrel Tapering
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The individual components of the primary endpoint. All cause mortality. [ Time Frame: 3 months after randomization ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 3000
Study Start Date: April 2008
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00640679

Locations
Germany
Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
Medizinische Klinik, Klinikum rechts der Isar
Munich, Germany, 81675
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Investigators
Study Chair: Adnan Kastrati, MD Deutsches Herzzentrum Muenchen
Principal Investigator: Julinda Mehilli, MD Deutsches Herzzentrum Muenchen
  More Information

No publications provided

Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT00640679     History of Changes
Other Study ID Numbers: GE IDE No. A01308
Study First Received: March 17, 2008
Last Updated: June 11, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Deutsches Herzzentrum Muenchen:
Clopidogrel
Drug-eluting Stent

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clopidogrel
Ticlopidine
Platelet Aggregation Inhibitors
Hematologic Agents
 Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013