Pharmacogentic Screening of Coumarine Based Oral Anticoag... | NCT03180567

Studies
Pharmacogentic Screening of Coumarine Based Oral Anticoagulant Using Next Generation Seguencer

NCT03180567

Sponsor

Tanta University

Status

Unknown status

Last Update Posted

Jun 8, 2017Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Thrombosis

Interventions

Genetic Mutations

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 6, 2017Actual

Primary Completion Date

Dec 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Jun 6, 2017

First Submission Date that Met QC Criteria

Jun 6, 2017

First Posted Date

Jun 8, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 6, 2017

Last Update Posted Date

Jun 8, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Warfarin resistant patients	Experimental	Genetic Mutations	Diagnostic Test: Genetic Mutations
Control	Placebo Comparator	Genetic Mutations	Diagnostic Test: Genetic Mutations

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Genetic Mutations	Diagnostic Test	By next generation sequencing	Control Warfarin resistant patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of patients with genetic polymorphism	patients with abnormal polymorphisms	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with thrombosis and warfarin resistance

Exclusion Criteria:

less than 18 years

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Amr Gawaly, Ass Prof	Contact	01221793033		amrgawaly1@yahoo.com

Overall Officials

Name	Affiliation	Role
Amr Gawaly, Consultant	Hematology Dept. - Tanta University	Principal Investigator
Said Hammad Abdou, Prof	Clinical Pathology dept.- Tanta University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sherief Abd-Elsalam	Recruiting	Cairo	Tanta		Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013927	Thrombosis

Ancestor Terms

ID	Term
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009154	Mutation

Ancestor Terms

ID	Term
D014644	Genetic Variation
D055614	Genetic Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided