- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03806894
Clopidogrel Resistance in Stroke Patients From Different Ethnicities
Prospective Study Evaluating Clopidogrel Resistance in Ischemic Stroke Patients From Different Ethnicities
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pregnant patients will be excluded
- Ages below 18
- Patients not able to provide informed consent
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Jewish communities
Ashkenazi, Sephardi, Ethiopian
|
Platelet aggregation will be determined by vasodilator-stimulated phosphoprotein (VASP) assay
|
Arab populations
Muslim, Christian, Druze
|
Platelet aggregation will be determined by vasodilator-stimulated phosphoprotein (VASP) assay
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rates of clopidogrel resistance assessed among the different ethnicities
Time Frame: 6 months
|
6 months
|
Identifying of high-risk subgroups of adverse clinical outcomes
Time Frame: 6 to 12 months
|
6 to 12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0112-17-ZIV
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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