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Clopidogrel Reloading in Clopidogrel Resistant Patients With ACS

Clopidogrel Reloading in Clopidogrel Resistant Patients With ACS

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00444132
Enrollment
50
Registered
2007-03-07
Start date
2005-03-31
Completion date
2007-06-30
Last updated
2007-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clopidogrel Non-Responsiveness

Keywords

clopidogrel, platelets, acute coronary syndrome, percutaneous coronary intervention

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.

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.

Interventions

DRUGclopidogrel

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frame
Platelet reactivity

Secondary

MeasureTime frame
recurrent ACS
stroke
death

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026