Pharmacogentic Screening of Coumarine Based Oral Anticoagulant Using Next Generation Seguencer

NCT ID: NCT03180567

Last Updated: 2017-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-06

Study Completion Date

2020-12-31

Brief Summary

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As drug response is a complex trait in the majority of cases using an optimal starting dose for an individual may reduce the time taken to reach a stable INR, and reduce the risk of having either a high INR (with a risk of bleeding) or a low INR (with a risk of thrombosis)

Detailed Description

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The results of this project will benefit in (1) Identification of novel features or mutation types in warfarin resistance genomes. (2) To determine whether other polymorphisms in noncoding regions or their unique haplotype combinations contribute to the variability in the maintenance dose of warfarin, and (3)personalization of the drug and deciding the correct dose from the start.

Conditions

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Thrombosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Warfarin resistant patients

Genetic Mutations

Group Type EXPERIMENTAL

Genetic Mutations

Intervention Type DIAGNOSTIC_TEST

By next generation sequencing

Control

Genetic Mutations

Group Type PLACEBO_COMPARATOR

Genetic Mutations

Intervention Type DIAGNOSTIC_TEST

By next generation sequencing

Interventions

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Genetic Mutations

By next generation sequencing

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients with thrombosis and warfarin resistance

Exclusion Criteria

* less than 18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amr Gawaly, Consultant

Role: PRINCIPAL_INVESTIGATOR

Hematology Dept. - Tanta University

Said Hammad Abdou, Prof

Role: PRINCIPAL_INVESTIGATOR

Clinical Pathology dept.- Tanta University

Enas Abdul-Raouf, Lecturer

Role: STUDY_DIRECTOR

Biology and Genetics- Tanta University

Abdelaziz Zidane, Lecturer

Role: STUDY_CHAIR

Genetics-Damanhour University

Locations

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Sherief Abd-Elsalam

Cairo, Tanta, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Amr Gawaly, Ass Prof

Role: CONTACT

01221793033

Facility Contacts

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Sherief Abd-elsalam, lecturer

Role: primary

00201000040794

Other Identifiers

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Prof Amr gawaly

Identifier Type: -

Identifier Source: org_study_id

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