N/A
N=100
Aspirin and Clopidogrel Reactivity in Patients With Critical Limb Ischemia (CLI)
Critical Limb Ischemia
Bottom Line
View on ClinicalTrials.gov: NCT02094755 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Asses the Prevalence of High On-treatment Platelet Reactivity in Critical Limb Ischemia Patients Treated With Aspirin and Clopidogrel. — 18; 17; 8; 57 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Blood draw only (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Southern California
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Asses the Prevalence of High On-treatment Platelet Reactivity in Critical Limb Ischemia Patients Treated With Aspirin and Clopidogrel. |
18; 17; 8; 57 | — |
Summary
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).
Eligibility Criteria
Inclusion Criteria
- EXPERIMENTAL GROUP: Patients with a diagnosis of critical limb ischemia (CLI) and uninterrupted treatment with aspirin and/or clopidogrel for at least one week before testing.
- CONTROL GROUP: 10 normal volunteers without any known co-morbidities
Exclusion Criteria
- Chronic use of nonsteroidal anti-inflammatory drugs, thrombocytopenia (platelet count <100 × 103/μl), use of an oral anticoagulant (warfarin), glycoprotein (GP) IIb/IIIa inhibitors, or fibrinolytic drugs within 30 days before testing. Any documented history of hypercoaguable states or history of medication non-compliance.
Data sourced from ClinicalTrials.gov (NCT02094755). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.