Clopidogrel Reloading in Clopidogrel Resistant Patients With ACS
Information source: Sheba Medical Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Clopidogrel Non-Responsiveness
Intervention: clopidogrel (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Sheba Medical Center Official(s) and/or principal investigator(s):
Shlomi Matetzky, MD, Principal Investigator, Affiliation: Senior Physician, ICCU, Sheba Medical Center.
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.
Clinical Details
Official title: Clopidogrel Reloading in Clopidogrel Resistant Patients With ACS
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: Platelet reactivity
Secondary outcome: recurrent ACSstroke death
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
ICCU, Sheba Medical Center, Tel-hashomer, Ramat Gan, Israel
Additional Information
Starting date: March 2005
Ending date: June 2007
Last updated: September 19, 2007
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