Details - Clinical Research

Clinical Research Details

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Descriptive Information

Title

The role of CYP2C9 and VKORC1 genetic polymorphisms on anticoagulation

Investigator Name

Nathalie Khoueiry-Zgheib

nk16@aub.edu.lb

Protocol Id

N/A

Status

Completed- Has Results

Study Type

Observational A clinical study in which participants identified as belonging to study groups are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions (as in an interventional study).

Phase

Looking for Med Students Volunteers

Conditions and Keywords

Conditions

Subjects on anticoagulants for various conditions

Keywords

Anticoagulants, genetic polymorphisms

Study Design

Primary Purpose

Basic / Translational

Classification

Safety and/or Efficacy Study

Time Perspective

Observational Study

Masking

N/A: Not Applicable

Intervention Model

N/A: Not Applicable

Allocation

N/A: Not Applicable

Observational Study Model

Cohort

Eligibility and IRB

Gender

Both

Age Limits

Min:

Max:

IRB Approval

Yes

Healthy Volunteer

Study Description

In this study, we assessed the impact of CYP2C9*2, CYP2C9*3 and/or VKORC1 -1639G>A/1173C>T single nucleotide polymorphisms on oral anticoagulants in a cohort of 231 Lebanese subjects who were on long-term warfarin or acenocoumarol maintenance therapy with International Normalized Ratio (INR) monitored at the American University of Beirut Medical Center. We showed that both CYP2C9 and VKORC1 polymorphisms are common in the Lebanese and influence warfarin and acenocoumarol dose requirements, with CYP2C9*2 polymorphism having a lesser effect on acenocoumarol.

Manuscript 1: Esmerian MO, Mitri Z, Habbal MZ, Geryess E, Zaatari G, Alam S, Skouri HN, Mahfouz RA, Taher A, Zgheib NK. Influence of CYP2C9 and VKORC1 polymorphisms on warfarin and acenocoumarol in a sample of Lebanese people. J Clin Pharmacol. 2011 Oct;51(10):1418-28 (PMID: 21148049).

Manuscript 2: Isma'eel HA, Sakr GE, Habib RH, Almedawar MM, Zgheib NK, Elhajj IH. Improved accuracy of anticoagulant dose prediction using a pharmacogenetic and artificial neural network-based method. Eur J Clin Pharmacol. 2014 Mar;70(3):265-73 (PMID: 24297344).

Population Description

Lebanese subjects taking either warfarin (Coumadin®) or acenocoumarol (Sintrom®) who had INR values determined at the American University of Beirut Medical Center (AUBMC) between 2008 and 2009.

Sampling Method

Referral for INR testing at the AUBMC lab.

Inclusion Criteria

Age above 18 years, therapy for at least 2 months, same weekly dose of oral anticoagulant over the past 3 INR examinations (maintenance therapy), and clinical follow up by AUBMC physicians.

Exclusion Criteria

Refusal of consent.

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