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Trial record 46 of 602 for:    ASPIRIN AND clopidogrel

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
Sponsor:
Information provided by (Responsible Party):
Leonardo Clavijo, University of Southern California

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 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

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Single cohort
Single cohort will receive blood draw.
Other: Blood draw only
Blood draw only




Primary Outcome Measures :
  1. 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
Blood Draw


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 medical treatment are receiving dual antiplatelet therapy with aspirin 81 mg and clopidogrel 75 mg daily.
Criteria

Inclusion Criteria:

  • EXPERIMENTAL GROUP: Patients with a diagnosis of 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), GPIIb/IIIa inhibitors, or fibrinolytic drugs within 30 days before testing. Any documented history of hypercoaguable states or history of medication non-compliance.

Information from the National Library of Medicine

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


Contacts
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Contact: Christine Tam, RN 3234426863 christine.tam@med.usc.edu
Contact: Jorge Caro, MPH 323-382-7646 Jorge.Caro@med.usc.edu

Locations
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United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Christine Tam, RN    323-442-6863    christine.tam@med.usc.edu   
Contact: Jorge Caro, MPH    3233827646    jorge.caro@med.usc.edu   
Principal Investigator: Leonardo Clavijo, MD, PhD         
Sponsors and Collaborators
University of Southern California
Investigators
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Principal Investigator: Leonardo Clavijo, MD, PhD University of Southern California

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Responsible Party: Leonardo Clavijo, Assistant Professor of Clinical Medicine Director of Vascular Medicine & Peripheral Interventions, University of Southern California
ClinicalTrials.gov Identifier: NCT02094755     History of Changes
Other Study ID Numbers: D5130L00047/ISSBRIL0152
First Posted: March 24, 2014    Key Record Dates
Last Update Posted: October 30, 2014
Last Verified: October 2014

Keywords provided by Leonardo Clavijo, University of Southern California:
critical limb ischemia, High on-treatment platelet reactivity, HPR, aspirin, clopidogrel

Additional relevant MeSH terms:
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Aspirin
Clopidogrel
Ischemia
Pathologic Processes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents