NCT03180567

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

June 6, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

June 8, 2017

Status Verified

June 1, 2017

Enrollment Period

3.5 years

First QC Date

June 6, 2017

Last Update Submit

June 6, 2017

Conditions

Thrombosis

Outcome Measures

Primary Outcomes (1)

  • number of patients with genetic polymorphism

    patients with abnormal polymorphisms

    6 months

Study Arms (2)

Warfarin resistant patients

EXPERIMENTAL

Genetic Mutations

Diagnostic Test: Genetic Mutations

Control

PLACEBO COMPARATOR

Genetic Mutations

Diagnostic Test: Genetic Mutations

Interventions

Genetic MutationsDIAGNOSTIC_TEST

By next generation sequencing

ControlWarfarin resistant patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with thrombosis and warfarin resistance

You may not qualify if:

  • less than 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sherief Abd-Elsalam

Cairo, Tanta, Egypt

RECRUITING

MeSH Terms

Conditions

Thrombosis

Interventions

Mutation

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Genetic VariationGenetic Phenomena

Study Officials

  • Amr Gawaly, Consultant

    Hematology Dept. - Tanta University

    PRINCIPAL INVESTIGATOR

  • Said Hammad Abdou, Prof

    Clinical Pathology dept.- Tanta University

    PRINCIPAL INVESTIGATOR

  • Enas Abdul-Raouf, Lecturer

    Biology and Genetics- Tanta University

    STUDY DIRECTOR

  • Abdelaziz Zidane, Lecturer

    Genetics-Damanhour University

    STUDY CHAIR

Central Study Contacts

Amr Gawaly, Ass Prof

CONTACT

01221793033amrgawaly1@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2017

First Posted

June 8, 2017

Study Start

June 6, 2017

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

June 8, 2017

Record last verified: 2017-06

Locations

EG(1)