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Clopidogrel Resistance in Stroke Patients From Different Ethnicities

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ClinicalTrials.gov Identifier: NCT03806894
Recruitment Status : Not yet recruiting
First Posted : January 16, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Najib Dally, Ziv Hospital

Brief Summary:
Clopidogrel is an anti-platelet agent used to inhibit blood clots. Variation in response to clopidogrel has been reported among different population and may lead to reoccurring ischemic events. The aim of the present study is to evaluate the incidence of clopidogrel resistance in ischemic stroke patients from different ethnicities in Northern Israel and to find different strategies to overcome high platelet reactivity including clopidogrel dose adjustment or the choice of alternative agents. Quantification of platelet aggregation will be determined by vasodilator stimulated phosphoprotein (VASP) assay.

Condition or disease Intervention/treatment
Clopidogrel, Poor Metabolism of Ischemic Stroke Diagnostic Test: Quantification of platelet aggregation

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study Evaluating Clopidogrel Resistance in Ischemic Stroke Patients From Different Ethnicities
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Clopidogrel

Group/Cohort Intervention/treatment
Jewish communities
Ashkenazi, Sephardi, Ethiopian
Diagnostic Test: Quantification of platelet aggregation
Platelet aggregation will be determined by vasodilator-stimulated phosphoprotein (VASP) assay

Arab populations
Muslim, Christian, Druze
Diagnostic Test: Quantification of platelet aggregation
Platelet aggregation will be determined by vasodilator-stimulated phosphoprotein (VASP) assay




Primary Outcome Measures :
  1. Rates of clopidogrel resistance assessed among the different ethnicities [ Time Frame: 6 months ]
  2. Identifying of high-risk subgroups of adverse clinical outcomes [ Time Frame: 6 to 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This prospective study will be conducted in two sites (Ziv Medical Center, Safed, department of neurology, and Galilee Medical Center, Nahariya, department of neurology) on 300 patients from different ethnic backgrounds with an ischemic cerebrovascular event (ischemic stroke and TIA), treated with clopidrogel for secondary stroke prevention. The groups will consist of Jewish communities (Ashkenazi, Sephardi and Ethiopian) and Arab populations (Muslim, Christian and Druze).

To be considered eligible to participate in this study, patients have to be able to provide signed and dated written informed consent or written assent from their relatives. Both genders aged 18 and above are eligible for this trial. Pregnant patients will be excluded.

Criteria

Inclusion Criteria:

  1. Ability to provide written informed consent and to be compliant with protocol assessments.
  2. Ages 18 and above inclusive
  3. Both genders eligible for the study
  4. Diagnosis of ischemic cerebrovascular event

Exclusion Criteria:

  1. Pregnant patients will be excluded
  2. Ages below 18
  3. Patients not able to provide informed consent

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Responsible Party: Dr. Najib Dally, Director of Hematology Department, Ziv Hospital
ClinicalTrials.gov Identifier: NCT03806894     History of Changes
Other Study ID Numbers: 0112-17-ZIV
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Platelet Aggregation Inhibitors
Stroke
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Clopidogrel
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs