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Clopidogrel Reloading in Clopidogrel Resistant Patients With ACS

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ClinicalTrials.gov Identifier: NCT00444132
Recruitment Status : Completed
First Posted : March 7, 2007
Last Update Posted : September 20, 2007
Information provided by:

Study Description
Brief Summary:
Laboratory clopidogrel resistance is associated with adverse atherothrombotic events in patients with coronary artery disease. In the proposed study we wish to prospectively assess the effect of reloading with 600 mg clopidogrel, and administer maintenance treatment with clopidogrel 150 mg/day for one month in a group of acute myocardial infarction (AMI) patients who demonstrate non-responsiveness to clopidogrel.

Condition or disease Intervention/treatment Phase
Clopidogrel Non-Responsiveness Drug: clopidogrel Phase 3

Detailed Description:
Prior studies have demonstrated significant variability in platelet response to clopidogrel in patients with coronary artery disease (CAD). Up to 25% of patients have been shown to be non-responders to a conventional dose of clopidogrel. This phenomenon has been associated with higher incidence of recurrent cardiovascular (CVS) adverse events in patients with acute coronary syndrome (ACS), and higher incidence of peri-procedural myocardial damage, thrombotic complications, and ischemic events in patients undergoing elective percutaneous coronary intervention (PCI). Both the ex-vivo anti-platelet effect and the clinical benefit of clopidogrel are dose related. Moreover, in patients sustaining ACS while on maintenance clopidogrel treatment, reloading with 600 mg clopidogrel, resulted in further reduction in platelet aggregation, although the patients were not non-responders. Despite this, the effect of dose escalation has never been examined in patients resistant to clopidogrel. In the present study we wish to assess prospectively the effect of reloading with 600 mg clopidogrel, and double dose maintenance treatment (150 mg/day) for one month in acute myocardial infarction (AMI) patients who demonstrate non-respondese to clopidogrel.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clopidogrel Reloading in Clopidogrel Resistant Patients With ACS
Study Start Date : March 2005
Study Completion Date : June 2007

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U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Platelet reactivity

Secondary Outcome Measures :
  1. recurrent ACS
  2. stroke
  3. death

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age equal or over 18 years
  • acute coronary syndrome
  • Clopidogrel non-responsive
  • signed an informed consent

Exclusion Criteria:

  • Bleeding disorder
  • hypersensitivity to aspirin or clopidogrel
  • any contraindication to anti-thrombotic or anticoagulant therapy
  • active neoplastic disorder
Contacts and Locations

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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 ClinicalTrials.gov identifier (NCT number): NCT00444132

ICCU, Sheba Medical Center
Tel-hashomer, Ramat Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
Principal Investigator: Shlomi Matetzky, MD Senior Physician, ICCU, Sheba Medical Center.
More Information

ClinicalTrials.gov Identifier: NCT00444132     History of Changes
Other Study ID Numbers: SHEBA-05-3621-SM-CTIL
First Posted: March 7, 2007    Key Record Dates
Last Update Posted: September 20, 2007
Last Verified: September 2007

Keywords provided by Sheba Medical Center:
acute coronary syndrome
percutaneous coronary intervention

Additional relevant MeSH terms:
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
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors