Ignite Creation Date:
2024-05-06 @ 2:38 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02094755
Status:
COMPLETED
Last Update Posted:
2019-06-28
First Post:
2014-03-19
Brief Title:
Aspirin and Clopidogrel Reactivity in Patients With Critical Limb Ischemia CLI
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Prevalence of High On-Treatment Aspirin and Clopidogrel Platelet Reactivity in Patients With Critical Limb Ischemia
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor 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
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
Detailed Description:
This prospective clinical study will investigate the prevalence of high on- treatment platelet reactivity HPR in one hundred patients with critical limb ischemia CLI at the Keck Hospital of USC and Los Angeles County Medical Center LACUSC 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 purigenic receptor P2Y12 VN-P2Y12 assays All platelet function analyses will be performed once after a minimum of one week of uninterrupted dual antiplatelet therapy with aspirin and clopidogrel High on-treatment Platelet Reactivity on aspirin treatment HPRA group will be defined as aspirin reaction units ARU 550 by the VerifyNow ASA assay High on-treatment Platelet Reactivity on clopidogrel HPRC group will be defined as P2Y12 reaction units PRU 208 by the VerifyNow assay and Vasodilator-stimulated phosphoprotein-platelet reactivity index VASP-PRI 50 by the vasodilator-stimulated phosphoprotein VASP assay All other patients will be assigned to the adequate platelet reactivity on therapy APR group Prevalence of high on-treatment platelet reactivity will then be calculated for aspirin andor clopidogrel
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None