ASA/Plavix Resistance CLI
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|ClinicalTrials.gov Identifier: NCT02094755|
Recruitment Status : Unknown
Verified October 2014 by Leonardo Clavijo, University of Southern California.
Recruitment status was: Recruiting
First Posted : March 24, 2014
Last Update Posted : October 30, 2014
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 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 affiliated hospitals (Los Angeles County Hospital and Keck Hospital of USC).
|Condition or disease||Intervention/treatment|
|Critical Limb Ischemia||Other: Blood draw only|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Prevalence of High On-Treatment (Aspirin and Clopidogrel) Platelet Reactivity in Patients With Critical Limb Ischemia|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||May 2016|
|Estimated Study Completion Date :||June 2017|
Single cohort will receive blood draw.
Other: Blood draw only
Blood draw only
- Asses the prevalence of HPR in CLI patients treated with aspirin and clopidogrel. [ Time Frame: 1 week ]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 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
|Contact: Christine Tam, RNemail@example.com|
|Contact: Jorge Caro, MPH||323-382-7646||Jorge.Caro@med.usc.edu|
|United States, California|
|University of Southern California||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Christine Tam, RN 323-442-6863 firstname.lastname@example.org|
|Contact: Jorge Caro, MPH 3233827646 email@example.com|
|Principal Investigator: Leonardo Clavijo, MD, PhD|
|Principal Investigator:||Leonardo Clavijo, MD, PhD||University of Southern California|