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

PRIMARY FOCUS:PATIENT THAT TAKE CLOPIDOGREL Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01210248
• Other study ID #: NO 51/10
• Status: Recruiting
• Phase: N/A
• First received: September 26, 2010
• Last updated: September 27, 2010
• Start date: September 2010

Study information

• Verified date: May 2010
• Source: Assaf-Harofeh Medical Center
• Contact: ADINA BAR HAIM, PhD
• Phone: 08-9779897
• Email: dinab[@]asaf.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

The aim of this study is to check correlation between CYP2C19 genotype level of clopidogrel metabolite in plasma and platelet inhibition status.

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:

1. GENETIC (FOR CYP450 2C19)

2. PLATELET MAPPING TEST ( BY THROMBOELASTOGRAPH ASSAY)

3. CLOPIDOGREL INACTIVE METABOLITE DETERMINATION BY CHROMATOGRAPHIC METHOD

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• > 18 OLD PATIENTS

• THAT TAKE CLOPIDOGREL MORE THAN 1 WEEK

Exclusion Criteria:

• PREGNANCY

• CHRONIC LIVER DISEASES

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• PRIMARY FOCUS:PATIENT THAT TAKE CLOPIDOGREL

Intervention

Other:
• BLOOD COLLECTION
BLOOD SAMPLE WILL BE COLLECTED FOR 3 KINDS OF TESTS

Locations

Country	Name	City	State
Israel	Assaf Harofeh Medical Center	Zeriffin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel,