Adults 18 to 80, any sex, with Critical Limb Ischemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Asses the Prevalence of High On-treatment Platelet Reactivity in Critical Limb Ischemia Patients Treated With Aspirin and Clopidogrel.Primary· Single measurment after a minimum of one week of uninterrupted dual antiplatelet therapy with aspirin and clopidogrel
Platelet inhibition to aspirin will be evaluated with the VerifyNow® aspirin (ASA) test. Clopidogrel platelet inhibition will be evaluated with two different tests: the vasodilator-stimulated phosphoprotein (VASP) and the VerifyNow® purinergic receptor P2Y12 (VN-P2Y12) assays.
Group
Value
95% CI
Single Cohort
18
Single Cohort
17
Single Cohort
8
Single Cohort
57
Sponsor's own description
Critical Limb Ischemia (CLI) is defined as limb pain that occurs at rest, or impending limb loss that is caused by severe compromise of blood flow to the affected extremity. CLI is a major cause of death and disability (secondary to myocardial infarction, stroke and amputation). The mortality in patients with CLI approaches 25% and 50% at one and five years respectively. High on-treatment platelet reactivity (HPR) in patients treated with aspirin and clopidogrel (previously referred to as "resistance") is associated with an increased risk of recurrent cardiovascular events after percutaneous coronary interventions and acute coronary syndromes. The prevalence and significance of High on-treatment Platelet Reactivity (HPR) in patients with critical limb ischemia treated with aspirin and/or clopidogrel is not known.
The investigators project aims to investigate the prevalence of HPR (to aspirin and clopidogrel) in one hundred patients with diagnosis of critical limb ischemia encountered at University of Southern California (USC) affiliated hospitals (Los Angeles County Hospital and Keck Hospital of University of Southern California).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by University of Southern California
Last refreshed: 28 June 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02094755.