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NCT03806894 Clinical Trial

Clopidogrel Resistance in Stroke Patients From Different Ethnicities

Ischemic Stroke Clinical Trial

Official title:
Prospective Study Evaluating Clopidogrel Resistance in Ischemic Stroke Patients From Different Ethnicities

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03806894
Other study ID # 0112-17-ZIV
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 2019
Est. completion date December 2020

Study information
Verified date July 2019
Source Ziv Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 300
Est. completion date December 2020
Est. primary completion date October 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Quantification of platelet aggregation
Platelet aggregation will be determined by vasodilator-stimulated phosphoprotein (VASP) assay

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Ziv Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Rates of clopidogrel resistance assessed among the different ethnicities 6 months
Primary Identifying of high-risk subgroups of adverse clinical outcomes 6 to 12 months
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