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Genotype-guided Versus Standard for Warfarin Dosing

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ClinicalTrials.gov Identifier: NCT03479684
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Lu Hua, Chinese Academy of Medical Sciences, Fuwai Hospital

Brief Summary:
To compare the efficiency and safety between gene-oriented group and standard care group during 90 days of initial warfarin-treatment for requiring anticoagulation patients with valve replacement or atrial fibrillation with or without valvular heart disease。

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Valvular Heart Disease Other: Gene-directed dosage of warfarin Other: standard dosage of warfarin Not Applicable

Detailed Description:
Due to narrow therapeutic window, and individual differences in dosage, inappropriate use of warfarin may lead to serious complications and ineffective. Based on the results of the research on the transformation of warfarin pharmacogenomics, this study investigates the clinical application of gene-directed warfarin dose prediction model through the preset dosage regimen of warfarin during the initial treatment phase. Compared with the conventional treatment, that is to say empirical medication, this study is to verify the feasibility and value of gene-oriented warfarin dose prediction model, in order to establish a practical guidance to optimize the rational use of warfarin treatment program, to enable patients to obtain effective, safe warfarin dose, and to achieve the established anticoagulant strength faster and safer, as the same time, to reduce the times of patients was blood and the incidence of bleeding/embolism, and to save costs and ensure the safety of warfarin clinical medication.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 560 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial of Genotype-guided Versus Standard for Warfarin Dosing
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019


Arm Intervention/treatment
Experimental: Gene-directed group
the first day given model prediction dose * 1.5 times(<6mg);the second day given model prediction dose;adjusted dose based on INR from the third day
Other: Gene-directed dosage of warfarin
the first day given model prediction dose * 1.5 times(<6mg);the second day given model prediction dose;adjusted dose based on INR from the third day

Active Comparator: Standard care group
the first day given 4.5mg; adjusted dose based on INR from the second day
Other: standard dosage of warfarin
the first day given 4.5mg; adjusted dose based on INR from the second day




Primary Outcome Measures :
  1. therapeutic INR range (TTR) 90 [ Time Frame: at Day90 ]
    The percentage of time in therapeutic INR range (TTR) using the number of INRs within the therapeutic range divided by the number of INRs collected, will be assessed at Day90, and the TTR of all patients will be reported.


Secondary Outcome Measures :
  1. therapeutic INR range (TTR) 28 [ Time Frame: at Day28 ]
    The percentage of time in therapeutic INR range (TTR) using the number of INRs within the therapeutic range divided by the number of INRs collected, will be assessed at Day28, and the TTR of all patients will be reported.

  2. Time of the first time of the target INR [ Time Frame: 90 days ]
    Time of the first time for participants to reach the target INR will be collected and reported during the study.


Other Outcome Measures:
  1. thrombus or embolism or bleeding complications [ Time Frame: 90 days ]
    The number of thrombus or embolism or any hemorrhage events for participants through the study completion will be collected and assessed at Day90.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged from 18 to 70 years old, requiring anticoagulation because of valvular or non-valvular atrial fibrillation or after valvular replacement. Patients could visit to be followed up in our hospital clinic regularly and agree to participate in the clinical trial and sign a written informed consent.

Exclusion Criteria:

  • Patients will be excluded from the trial if aged <18 years old or > 75 years old, pregnant and lactating, if treated tricuspid valve replacement, or coronary artery bypass grafting before, if diagnosed with congenital heart disease, if known their CYP2C9 or VKORC1 genotype, if taken dicoumarol drugs previously or taking them now, if not suitable for enrollment judged by researchers.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479684


Contacts
Contact: Lu Hua, MD. PhD +861088396016 ethannan@126.com

Locations
China, Beijing
Chinese Academy of Medical Sciences Fuwai Hospital Recruiting
Beijing, Beijing, China, 100037
Sponsors and Collaborators
China National Center for Cardiovascular Diseases
Investigators
Principal Investigator: Lu Hua, MD. PhD Thrombosis and Vascular Medicine Center

Responsible Party: Lu Hua, chief physician of Thrombosis and Vascular Medicine Center Fuwai Hospitai, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier: NCT03479684     History of Changes
Other Study ID Numbers: Z171100001017216
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Consent for sharing of non identifiable study data for regulatory authorities.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lu Hua, Chinese Academy of Medical Sciences, Fuwai Hospital:
warfarin
gene

Additional relevant MeSH terms:
Atrial Fibrillation
Heart Diseases
Heart Valve Diseases
Arrhythmias, Cardiac
Cardiovascular Diseases
Pathologic Processes
Warfarin
Anticoagulants