Clopidogrel Reloading in Clopidogrel Resistant Patients With ACS
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Clopidogrel Non-Responsiveness |
Drug: clopidogrel |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Clopidogrel Reloading in Clopidogrel Resistant Patients With ACS |
- Platelet reactivity
- recurrent ACS
- stroke
- death
| Estimated Enrollment: | 50 |
| Study Start Date: | March 2005 |
| Study Completion Date: | June 2007 |
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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| 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| Israel | |
| ICCU, Sheba Medical Center | |
| Tel-hashomer, Ramat Gan, Israel | |
| Principal Investigator: | Shlomi Matetzky, MD | Senior Physician, ICCU, Sheba Medical Center. |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00444132 History of Changes |
| Other Study ID Numbers: | SHEBA-05-3621-SM-CTIL |
| Study First Received: | March 6, 2007 |
| Last Updated: | September 19, 2007 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Keywords provided by Sheba Medical Center:
|
clopidogrel platelets acute coronary syndrome percutaneous coronary intervention |
Additional relevant MeSH terms:
|
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