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Trial record 3 of 467 for:    ASPIRIN AND clopidogrel AND ischemic

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

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ClinicalTrials.gov Identifier: NCT02094755
Recruitment Status : Completed
First Posted : March 24, 2014
Results First Posted : June 28, 2019
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Leonardo Clavijo, University of Southern California

Tracking Information
First Submitted Date March 19, 2014
First Posted Date March 24, 2014
Results First Submitted Date March 31, 2017
Results First Posted Date June 28, 2019
Last Update Posted Date June 28, 2019
Actual Study Start Date June 19, 2013
Actual Primary Completion Date November 21, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 4, 2019)
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.
Original Primary Outcome Measures
 (submitted: March 21, 2014)
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.
Change History Complete list of historical versions of study NCT02094755 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Aspirin and Clopidogrel Reactivity in Patients With Critical Limb Ischemia (CLI)
Official Title Prevalence of High On-Treatment (Aspirin and Clopidogrel) Platelet Reactivity in Patients With Critical Limb Ischemia
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).

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 (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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood Draw
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.
Condition Critical Limb Ischemia
Intervention Other: Blood draw only
Blood draw only
Study Groups/Cohorts Single cohort
Single cohort will receive Blood draw only.
Intervention: Other: Blood draw only
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 21, 2014)
100
Original Estimated Enrollment Same as current
Actual Study Completion Date January 31, 2017
Actual Primary Completion Date November 21, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02094755
Other Study ID Numbers D5130L00047/ISSBRIL0152
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Leonardo Clavijo, University of Southern California
Study Sponsor University of Southern California
Collaborators Not Provided
Investigators
Principal Investigator: Leonardo Clavijo, MD, PhD University of Southern California
PRS Account University of Southern California
Verification Date April 2019