Clopidogrel Resistance in Stroke Patients From Different Ethnicities

NCT03806894 | Unknown

• 1 other identifier: 0112-17-ZIV
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Clopidogrel, Poor Metabolism of; Ischemic Stroke

Outcome Measures

Primary Outcomes (2)

• Rates of clopidogrel resistance assessed among the different ethnicities

  6 months

• Identifying of high-risk subgroups of adverse clinical outcomes

  6 to 12 months

Study Arms (2)

Jewish communities

Ashkenazi, Sephardi, Ethiopian

Diagnostic Test: Quantification of platelet aggregation

Arab populations

Muslim, Christian, Druze

Diagnostic Test: Quantification of platelet aggregation

Interventions

Quantification of platelet aggregation DIAGNOSTIC_TEST

Platelet aggregation will be determined by vasodilator-stimulated phosphoprotein (VASP) assay

Arab populations; Jewish communities

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Pregnant patients will be excluded
• Ages below 18
• Patients not able to provide informed consent

Sponsors & Collaborators

• Ziv Hospital: lead

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Hematology Department

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 16, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 10, 2019

Record last verified: 2019-07