Aspirin and Clopidogrel Reactivity in Patients With Critical Limb Ischemia (CLI)
|ClinicalTrials.gov Identifier: NCT02094755|
Recruitment Status : Completed
First Posted : March 24, 2014
Results First Posted : June 28, 2019
Last Update Posted : June 28, 2019
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).
|Condition or disease||Intervention/treatment|
|Critical Limb Ischemia||Other: Blood draw only|
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|Official Title:||Prevalence of High On-Treatment (Aspirin and Clopidogrel) Platelet Reactivity in Patients With Critical Limb Ischemia|
|Actual Study Start Date :||June 19, 2013|
|Actual Primary Completion Date :||November 21, 2016|
|Actual Study Completion Date :||January 31, 2017|
Single cohort will receive Blood draw only.
Other: Blood draw only
Blood draw only
- Asses the Prevalence of High On-treatment Platelet Reactivity in Critical Limb Ischemia Patients Treated With Aspirin and Clopidogrel. [ Time Frame: 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.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02094755
|United States, California|
|University of Southern California|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||Leonardo Clavijo, MD, PhD||University of Southern California|