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
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Clopidogrel, Poor Metabolism of
• Ischemia
• Ischemic Stroke
• Stroke

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