Clopidogrel, Poor Metabolism ofNCT03806894
Clopidogrel Resistance in Stroke Patients From Different Ethnicities
An observational study of Clopidogrel, Poor Metabolism of and Ischemic Stroke, run by Ziv Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clopidogrel, Poor Metabolism of, Ischemic Stroke
- What is being tested?
- Quantification of platelet aggregation
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Oct 2019to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Pregnant patients will be excluded
- Ages below 18
- Patients not able to provide informed consent
About this study
Official title: Prospective Study Evaluating Clopidogrel Resistance in Ischemic Stroke Patients From Different Ethnicities
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
- Being tested
- Quantification of platelet aggregation
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantification of platelet aggregationDiagnostic test
Platelet aggregation will be determined by vasodilator-stimulated phosphoprotein (VASP) assay
| Study group | Role | What they receive |
|---|---|---|
| Jewish communities | Ashkenazi, Sephardi, Ethiopian Receives: Diagnostic Test: Quantification of platelet aggregation | |
| Arab populations | Muslim, Christian, Druze Receives: Diagnostic Test: Quantification of platelet aggregation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of clopidogrel resistance assessed among the different ethnicities
Measured: 6 months
Identifying of high-risk subgroups of adverse clinical outcomes
Measured: 6 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study startOct 2019 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clopidogrel, Poor Metabolism ofStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Najib Dally, Ziv Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806894
- Sponsor's protocol ID
- 0112-17-ZIV
- Status last verified
- Jul 2019
- First submitted
- 15 Jan 2019
- Last updated
- 10 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Evaluating Clopidogrel Resistance in Ischemic Stroke Patients From Different Ethnicities
- ClinicalTrials.gov ID
- NCT03806894
- Acronym / sponsor ID
- 0112-17-ZIV
- Conditions
- Clopidogrel, Poor Metabolism of, Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- Oct 2019 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 16 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jewish communities | – | Diagnostic Test: Quantification of platelet aggregationAshkenazi, Sephardi, Ethiopian |
| Arab populations | – | Diagnostic Test: Quantification of platelet aggregationMuslim, Christian, Druze |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnant patients will be excluded
- Ages below 18
- Patients not able to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantification of platelet aggregationPlatelet aggregation will be determined by vasodilator-stimulated phosphoprotein (VASP) assay | Diagnostic test | Arab populations, Jewish communities |
Primary outcome
Rates of clopidogrel resistance assessed among the different ethnicities
Time frame: 6 months
Identifying of high-risk subgroups of adverse clinical outcomes
Time frame: 6 to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Clopidogrel, Poor Metabolism of and Ischemic Stroke, run by Ziv Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of clopidogrel resistance assessed among the different ethnicities (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019; AzTrials last refreshed its copy on 31 Oct 2026.