PRIMARY FOCUS:PATIENT THAT TAKE CLOPIDOGRELNCT01210248
Correlation Between CYP2C19 Genotype, Level Of Clopidogrel Metabolite And Platelet Inhibition Status
An observational study of PRIMARY FOCUS:PATIENT THAT TAKE CLOPIDOGREL, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
The aim of this study is to check correlation between CYP2C19 genotype level of clopidogrel metabolite in plasma and platelet inhibition status. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PRIMARY FOCUS:PATIENT THAT TAKE CLOPIDOGREL
- What is being tested?
- BLOOD COLLECTION
- How many people
- 500 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2010to Jan 2012
- 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: THE RESEARCH WILL INVOLVE PATIENTS THAT TAKE CLOPIDOGREL AND READY TO GIVE INFORMED CONSENT FOR GENETIC TESTING.
Who may be able to join
- > 18 OLD PATIENTS
- THAT TAKE CLOPIDOGREL MORE THAN 1 WEEK
Who cannot join
- PREGNANCY
- CHRONIC LIVER DISEASES
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Assaf Harofeh Medical Center
Zeriffin, Israel
ADINA BAR HAIM, PhD, 08-9779897, dinab@asaf.health.gov.il
VICTORIA PAPIASHVILI, M.Sc, victoriapapi@yahoo.com
About this study
The aim of this study is to check correlation between CYP2C19 genotype level of clopidogrel metabolite in plasma and platelet inhibition status.
Read the detailed description
THE FIRST PHASE OF THE RESEARCH WILL INVOLVE PATIENTS RECRUITMENT AND INFORMED CONSENT FOR GENETIC TESTING.THE MAJORITY OF PATIENTS WILL BE RECRUITED FROM EMERGENCY DEPARTMENT. EVERY PATIENT WILL BE ASKED ABOUT HIS AND HIS PARENT'S ETHNICITY (ASHKENASI OR SEPHARDY JEW) AND ADDITIONAL DRUGS HE TAKES. IF PATIENT AGREES TO PARTICIPATE IN THE STUDY , HIS BLOOD SAMPLE WILL BE COLLECTED FOR 3 KINDS OF TESTS:
- GENETIC (FOR CYP450 2C19)
- PLATELET MAPPING TEST ( BY THROMBOELASTOGRAPH ASSAY)
- CLOPIDOGREL INACTIVE METABOLITE DETERMINATION BY CHROMATOGRAPHIC METHOD
- Being tested
- BLOOD COLLECTION
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLOOD COLLECTIONOther
BLOOD SAMPLE WILL BE COLLECTED FOR 3 KINDS OF TESTS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PRIMARY FOCUS:PATIENT THAT TAKE CLOPIDOGRELStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01210248
- Sponsor's protocol ID
- NO 51/10
- Status last verified
- May 2010
- First submitted
- 26 Sep 2010
- Last updated
- 28 Sep 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between CYP2C19 Genotype, Level Of Clopidogrel Metabolite And Platelet Inhibition Status
- ClinicalTrials.gov ID
- NCT01210248
- Acronym / sponsor ID
- NO 51/10
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Sep 2010
- Primary completion
- Jan 2012
- First posted
- 28 Sep 2010 (estimated)
- 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.
The aim of this study is to check correlation between CYP2C19 genotype level of clopidogrel metabolite in plasma and platelet inhibition status.
Detailed description
THE FIRST PHASE OF THE RESEARCH WILL INVOLVE PATIENTS RECRUITMENT AND INFORMED CONSENT FOR GENETIC TESTING.THE MAJORITY OF PATIENTS WILL BE RECRUITED FROM EMERGENCY DEPARTMENT. EVERY PATIENT WILL BE ASKED ABOUT HIS AND HIS PARENT'S ETHNICITY (ASHKENASI OR SEPHARDY JEW) AND ADDITIONAL DRUGS HE TAKES. IF PATIENT AGREES TO PARTICIPATE IN THE STUDY , HIS BLOOD SAMPLE WILL BE COLLECTED FOR 3 KINDS OF TESTS:
- GENETIC (FOR CYP450 2C19)
- PLATELET MAPPING TEST ( BY THROMBOELASTOGRAPH ASSAY)
- CLOPIDOGREL INACTIVE METABOLITE DETERMINATION BY CHROMATOGRAPHIC METHOD
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- THE RESEARCH WILL INVOLVE PATIENTS THAT TAKE CLOPIDOGREL AND READY TO GIVE INFORMED CONSENT FOR GENETIC TESTING.
Key inclusion criteria (2 listed)
- > 18 OLD PATIENTS
- THAT TAKE CLOPIDOGREL MORE THAN 1 WEEK
Key exclusion criteria (2 listed)
- PREGNANCY
- CHRONIC LIVER DISEASES
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 |
|---|---|---|
| BLOOD COLLECTIONBLOOD SAMPLE WILL BE COLLECTED FOR 3 KINDS OF TESTS | Other | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2010.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PRIMARY FOCUS:PATIENT THAT TAKE CLOPIDOGREL, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 2 inclusion and 2 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 28 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact ADINA BAR HAIM, PhD (08-9779897, dinab@asaf.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 28 Sep 2010.