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

NCT02094755 | Completed Results DMC

• 1 other identifier: D5130L00047/ISSBRIL0152
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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 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).

Conditions

Critical Limb Ischemia

Keywords

ASA-PLAVIX Reactivity in CLI

Outcome Measures

Primary Outcomes (1)

• Asses the Prevalence of High On-treatment Platelet Reactivity in Critical Limb Ischemia Patients Treated 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.

  Single measurment after a minimum of one week of uninterrupted dual antiplatelet therapy with aspirin and clopidogrel

Study Arms (1)

Single cohort

Single cohort will receive Blood draw only.

Other: Blood draw only

Interventions

Blood draw only OTHER

Blood draw only

Single cohort

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patient population will include one-hundred patients with a diagnosis of CLI. We will only include in the study CLI patients who as part of their standard of care medical treatment are receiving dual antiplatelet therapy with aspirin 81 mg and clopidogrel 75 mg daily for at least one week.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Draw

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Results Point of Contact

• Title: Dr. Leonardo Clavijo
• Organization: University of Southern California

lclavijo@usc.edu

3234426130

Study Officials

• Leonardo Clavijo, MD, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Medicine Director of Vascular Medicine & Peripheral Interventions

Study Record Dates

• First Submitted: March 19, 2014
• First Posted: March 24, 2014
• Study Start: June 19, 2013
• Primary Completion: November 21, 2016
• Study Completion: January 31, 2017
• Last Updated: June 28, 2019
• Results First Posted: June 28, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)