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Correlation Between CYP2C19 Genotype, Level Of Clopidogrel Metabolite And Platelet Inhibition Status

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Assaf-Harofeh Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT01210248
First received: September 26, 2010
Last updated: September 27, 2010
Last verified: May 2010

September 26, 2010
September 27, 2010
September 2010
January 2012   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01210248 on ClinicalTrials.gov Archive Site
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Correlation Between CYP2C19 Genotype, Level Of Clopidogrel Metabolite And Platelet Inhibition Status
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The aim of this study is to check correlation between CYP2C19 genotype level of clopidogrel metabolite in plasma and platelet inhibition status.

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:

  1. GENETIC (FOR CYP450 2C19)
  2. PLATELET MAPPING TEST ( BY THROMBOELASTOGRAPH ASSAY)
  3. CLOPIDOGREL INACTIVE METABOLITE DETERMINATION BY CHROMATOGRAPHIC METHOD
Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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Non-Probability Sample

THE RESEARCH WILL INVOLVE PATIENTS THAT TAKE CLOPIDOGREL AND READY TO GIVE INFORMED CONSENT FOR GENETIC TESTING.

PRIMARY FOCUS:PATIENT THAT TAKE CLOPIDOGREL
Other: BLOOD COLLECTION
BLOOD SAMPLE WILL BE COLLECTED FOR 3 KINDS OF TESTS
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
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January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • > 18 OLD PATIENTS
  • THAT TAKE CLOPIDOGREL MORE THAN 1 WEEK

Exclusion Criteria:

  • PREGNANCY
  • CHRONIC LIVER DISEASES
Both
18 Years and older
No
Contact: ADINA BAR HAIM, PhD 08-9779897 dinab@asaf.health.gov.il
Contact: VICTORIA PAPIASHVILI, M.Sc 0577345973 victoriapapi@yahoo.com
Israel
 
NCT01210248
NO 51/10
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Assaf-Harofeh Medical Center
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Assaf-Harofeh Medical Center
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP