NCT02710747

Brief Summary

To value the accuracy of the dosing algorithm published by the International Warfarin Pharmacogenetics Consortium in Chinese patients after heart valve replacement. To value the accuracy of warfarin pharmacogenomics algorithm by the algorithm calculated dose and actual dose in the Chinese patients.

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
500

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2015

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

March 17, 2016

Status Verified

December 1, 2015

Enrollment Period

1.4 years

First QC Date

February 25, 2016

Last Update Submit

March 11, 2016

Conditions

Heart Valve DiseaseOlder Than 18-years-oldWithout Any Liver or Kidney Diseases

Keywords

warfarinChinese patientsheart valve replacement

Outcome Measures

Primary Outcomes (1)

  • The perccentage of time that the INR was in the therapeutic range

    3 months

Secondary Outcomes (1)

  • all drainage fluid of every patient

    1 week after operation

Study Arms (2)

Genetic Group

EXPERIMENTAL

Dose (mg/week) = \[5.6044 - 0.02614 × Age \[in years\] + 0.0087 × Height \[cm\] + 0.0128 × Weight \[kg\] - 0.8677 × VKORC1 A/G -1.6974 × VKORC1 A/A - 0.5211 × CYP2C9 \*1/\*2 - 0.9357 × CYP2C9 \*1/\*3 - 1.0616 × CYP2C9 \*2/\*2 - 1.9206 × CYP2C9\*2/\*3 - 2.3312 × CYP2C9 \*3/\*3 - 0.1092 × Asian race - 0.5503 × amiodarone \]2

Genetic: CYP2C9;VKORC1

Control Group

NO INTERVENTION

Dose for the first three days after operation will be 4.5mg/d.

Interventions

CYP2C9;VKORC1GENETIC
Genetic Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • atrial fibrillation
  • heart valve replacement
  • VTE

You may not qualify if:

  • severe liver or kidney diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Heart Valve DiseasesKidney Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Chen Yongbin, master

CONTACT

+8618688859129chenyb1020@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2016

First Posted

March 17, 2016

Study Start

January 1, 2015

Primary Completion

June 1, 2016

Study Completion

July 1, 2016

Last Updated

March 17, 2016

Record last verified: 2015-12

Locations

CN(1)