Clinical Trials Logo
  1. Home
  2. Critical Limb Ischemia
  3. NCT02094755

Aspirin and Clopidogrel Reactivity in Patients With Critical Limb Ischemia (CLI)

Critical Limb Ischemia Clinical Trial

Official title:
Prevalence of High On-Treatment (Aspirin and Clopidogrel) Platelet Reactivity in Patients With Critical Limb Ischemia

Clinical Trial 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).

Clinical Trial 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 (LAC+USC). 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 and/or clopidogrel ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02094755
Study type Observational
Source University of Southern California
Contact
Status Completed
Phase
Start date June 19, 2013
Completion date January 31, 2017
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03987061 - MOTIV Bioresorbable Scaffold in BTK Artery Disease N/A
Recruiting NCT03668353 - Recombinant SeV-hFGF2/dF Injection for PAOD Phase 1
Recruiting NCT04110964 - Evaluation of Safety and Tolerability of Libella Gene Therapy for Critical Limb Ischemia: AAV- hTERT Phase 1
Not yet recruiting NCT03994666 - Cell Therapy in Critical Limb Ischemia Phase 2
Recruiting NCT02389023 - Comparison of Prevena Negative Pressure Incision Management System vs. Standard Dressing After Vascular Surgery N/A
Not yet recruiting NCT02498080 - Drug Eluting Balloons PTA in Infra-popliteal Arteries in Patients With Critical Limb Ischemia N/A
Completed NCT02539940 - Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment
Recruiting NCT02239419 - Evaluation of Carbothera in the Treatment of Foot Ulcers N/A
Recruiting NCT01938872 - Evaluating the Effectiveness of Paclitaxel-eluting Balloons for Below-the-knee Angioplasty in Patients With Critical Limb Ischemia N/A
Active, not recruiting NCT01211925 - Distal Venous Arterialisation of Ischemic Limb Phase 2/Phase 3
Completed NCT02454231 - Monocentric Trial: Stem Cell Emergency Life Threatening Limbs Arteriopathy (SCELTA) Phase 2/Phase 3
Completed NCT01758874 - Study to Explore the Effect of Lowering Blood Viscosity in Patients With Treatment-resistant Critical Limb Ischemia Phase 2
Completed NCT02475200 - Phoenix Post-Approval Registry - Using the Phoenix Atherectomy Systems
Recruiting NCT04583436 - Efficacy and Safety Comparison of the Open and Endovascular Surgical Methods for the Treatment of Long Atherosclerotic Lesions of the Femoral-popliteal Segment Below the Knee, TASC D in Patients With Critical Limb Ischemia N/A
Completed NCT04071782 - Investigating the Safety and Efficacy of the Treatment With the Selution Sirolimus Coated Balloon in TASC C and D Tibial Occlusive Disease in Patients With Critical Limb Ischemia From Singapore N/A
Completed NCT03669458 - Feasibility Clinical Trial Using the SPUR System to Demonstrate Safety and Efficacy. N/A
Not yet recruiting NCT06007469 - Pedal Acceleration Time (PAT) as a Measure of Foot Perfusion
Recruiting NCT04110327 - An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease
Completed NCT02260622 - Pilot Study to Examine the Use of Rivaroxaban After Angioplasty for Critical Limb Ischemia Phase 2
Recruiting NCT02054416 - External Compression Therapy for Secondary Prevention of Lower-Limb Loss and Cardiovascular Mortality N/A