NCT03797534

Brief Summary

The purpose of this study is to explore the individualized administration model of warfarin suitable for Chinese people, and provide a scientific reference for the use of warfarin to Chinese people.

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
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

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

January 6, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 9, 2019

Completed
23 days until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

2.9 years

First QC Date

January 6, 2019

Last Update Submit

January 13, 2019

Conditions

Heart Valve Prosthesis

Keywords

warfaringene

Outcome Measures

Primary Outcomes (4)

  • excessive anticoagulant time ratio

    INR\>3，INR\>4

    3 months postoperatively

  • The occurrence of primary bleeding events

    gastrointestinal hemorrhage, intracerebral hemorrhage,etc

    3 months postoperatively

  • The occurance of secondary bleeding events

    nasal bleeding, skin stasis,etc

    3 months postoperatively

  • The occurrence of thrombosis events

    ischemic stroke, deep vein thrombosis,etc

    3 months postoperatively

Secondary Outcomes (8)

  • Percentage of time in therapeutic range

    3 months, 6 months, 12 months postoperatively

  • The time required to reach the treatment target INR for the first time;

    3 months postoperatively

  • The time required from the beginning of treatment to the stable dose;

    3 months postoperatively

  • The percentage of time below the target INR range;

    3 months postoperatively

  • The percentage of time above the target INR range;

    3 months postoperatively

  • +3 more secondary outcomes

Study Arms (2)

Standard anticoagulant group

NO INTERVENTION

Bayesian model group

EXPERIMENTAL
Other: dose regime

Interventions

dose regimeOTHER

The initial dose of the experimental group will be calculated by the Bayesian model.

Bayesian model group

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 14 years old；
  • Warfarin anticoagulant therapy is required for at least 3 months；
  • The genotype of patient VKORC1 is non-AA, CYP2C9 genotype is non\*1/\*1； the patients who are followed up, regularly monitored for INR and willing to provide peripheral blood for DNA extraction and genetic testing；
  • The patient or family members can understand the research plan and will participate in this study and provide a written informed consent；

You may not qualify if:

  • Severe liver dysfunction (ChildPugh ≥ 10);
  • Severe infection, respiratory failure;
  • Severe heart failure ( NYHA ≥ IV);
  • Severe renal insufficiency (Ccr ≤ 20ml / min);
  • Cancer;
  • Diseases of the blood system;
  • Severe pulmonary hypertension (PAPm ≥ 45mmHg);
  • Abnormal thyroid function;
  • Patients with a history of venous thromboembolism, or serious events such as severe bleeding or embolism;
  • Women who are pregnant or breastfeeding;
  • Taking or planning to take other oral anticoagulants;
  • The base INR value is \>1.4;
  • VKORC1, CYP2C9 genotypes are AA, \*1/\*1;
  • Secondary valve replacement surgery;
  • Emergency hospital admission for valve surgery;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Department of Cardiovascular Surgery

Fuzhou, Fujian, 350001, China

RECRUITING

Related Publications (6)

  • Gage BF, Eby C, Johnson JA, Deych E, Rieder MJ, Ridker PM, Milligan PE, Grice G, Lenzini P, Rettie AE, Aquilante CL, Grosso L, Marsh S, Langaee T, Farnett LE, Voora D, Veenstra DL, Glynn RJ, Barrett A, McLeod HL. Use of pharmacogenetic and clinical factors to predict the therapeutic dose of warfarin. Clin Pharmacol Ther. 2008 Sep;84(3):326-31. doi: 10.1038/clpt.2008.10. Epub 2008 Feb 27.

    PMID: 18305455BACKGROUND

  • International Warfarin Pharmacogenetics Consortium; Klein TE, Altman RB, Eriksson N, Gage BF, Kimmel SE, Lee MT, Limdi NA, Page D, Roden DM, Wagner MJ, Caldwell MD, Johnson JA. Estimation of the warfarin dose with clinical and pharmacogenetic data. N Engl J Med. 2009 Feb 19;360(8):753-64. doi: 10.1056/NEJMoa0809329.

    PMID: 19228618BACKGROUND

  • Hamberg AK, Hellman J, Dahlberg J, Jonsson EN, Wadelius M. A Bayesian decision support tool for efficient dose individualization of warfarin in adults and children. BMC Med Inform Decis Mak. 2015 Feb 7;15:7. doi: 10.1186/s12911-014-0128-0.

    PMID: 25889768BACKGROUND

  • Pirmohamed M, Burnside G, Eriksson N, Jorgensen AL, Toh CH, Nicholson T, Kesteven P, Christersson C, Wahlstrom B, Stafberg C, Zhang JE, Leathart JB, Kohnke H, Maitland-van der Zee AH, Williamson PR, Daly AK, Avery P, Kamali F, Wadelius M; EU-PACT Group. A randomized trial of genotype-guided dosing of warfarin. N Engl J Med. 2013 Dec 12;369(24):2294-303. doi: 10.1056/NEJMoa1311386. Epub 2013 Nov 19.

    PMID: 24251363BACKGROUND

  • Kimmel SE, French B, Kasner SE, Johnson JA, Anderson JL, Gage BF, Rosenberg YD, Eby CS, Madigan RA, McBane RB, Abdel-Rahman SZ, Stevens SM, Yale S, Mohler ER 3rd, Fang MC, Shah V, Horenstein RB, Limdi NA, Muldowney JA 3rd, Gujral J, Delafontaine P, Desnick RJ, Ortel TL, Billett HH, Pendleton RC, Geller NL, Halperin JL, Goldhaber SZ, Caldwell MD, Califf RM, Ellenberg JH; COAG Investigators. A pharmacogenetic versus a clinical algorithm for warfarin dosing. N Engl J Med. 2013 Dec 12;369(24):2283-93. doi: 10.1056/NEJMoa1310669. Epub 2013 Nov 19.

    PMID: 24251361BACKGROUND

  • Li X, Yang J, Wang X, Xu Q, Zhang Y, Yin T. Clinical benefits of pharmacogenetic algorithm-based warfarin dosing: meta-analysis of randomized controlled trials. Thromb Res. 2015 Apr;135(4):621-9. doi: 10.1016/j.thromres.2015.01.018. Epub 2015 Jan 17.

    PMID: 25628141BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The director of the department of cardiovascular surgery

Study Record Dates

First Submitted

January 6, 2019

First Posted

January 9, 2019

Study Start

February 1, 2019

Primary Completion

January 1, 2022

Study Completion

January 1, 2023

Last Updated

January 15, 2019

Record last verified: 2019-01

Locations

CN(1)