UMIN-CTR Clinical Trial

Basic information
Public title	Genotype-Based Warfarin Therapy (GENWAT) study
Acronym	Genotype-Based Warfarin Therapy (GENWAT) study
Scientific Title	Genotype-Based Warfarin Therapy (GENWAT) study
Scientific Title:Acronym	Genotype-Based Warfarin Therapy (GENWAT) study
Region	Japan

Condition
Condition	Atrial fibrillation
Classification by specialty	Medicine in general Cardiology Geriatrics
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	Validation of warfarin dosing algorism using genotypes of CYP2C9 and VKORC1 SNPs and clinical information
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1) Efficacy i) Proportion of patients reaching therapeutic INR range (1.6 to 2.5) at week 2, 4 and 8 ii) Time to the therapeutic INR range 2) Safety i) Bleeding (hematoma, hemorrhage in CNS, GI, GU, pulmonary/upper respiratory, petechiae/purpura, other hemorrhage) ii) Thromboembolism (cerebral embolism, cardiac thrombosis, pulmonary embolism, deep vein thrombosis) iii) INR>=4 iv) Discontinuation of warfarin due to inhibition of coagulation v) Use of Vitamin K medication
Key secondary outcomes	1) Efficacy i) Total number of dose adjustments for reaching therapeutic INR range ii) Total number of INR measurements for reaching therapeutic INR range iii) Differences between initial and maintenance dosages

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	PG Arm: Decision of initial dosage using warfarin dosing algorism by genotype and clinical information (to a maximum of 5 mg).
Interventions/Control_2	STD Arm: Initiation of warfarin treatment at a dose of 1 to 2 mg.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Adult Japanese males and females with atrial fibrillation, who will take warfarin 2) Patients who can understand the contents of this study and will voluntarily give written informed consent
Key exclusion criteria	1) Patients with a history of hypersensitivity to warfarin 2) Pregnancy and lactation patients 3) Patients with severe renal failure (serum creatinine>=2.5 mg/dL, patients on hemodialysis) 4) Patients with cirrhosis 5) Patients with hypoproteinemia (serum albumin<=2.5 g/dL) 6) Patients who require special attention for dosage adjustment 7) Patients with bleeding and who are potentially bleeding 8) Patient who are incapable to understand the contents of this study and will not give informed consent 9) Patients who participate in other clinical studies 10) Patients judged by investigators as ineligible for study enrollment 11) Patients who require invasive treatment during this study
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Middle name Last name Michiaki Kubo
Organization	RIKEN
Division name	Center for Integrative Medical Sciences
Zip code
Address	1-7-22, Suehiro-cho, Tsurumi-ku, Yokohama 230-0045, Japan
TEL	045-503-9607
Email

Public contact
Name of contact person	1st name Middle name Last name
Organization	Institute of Medical Science, The University of Tokyo
Division name	Biobank Japan
Zip code
Address	4-6-1, Shirokanedai, Minato-ku 108-8639, Japan
TEL	03-5449-5122
Homepage URL	http://www.biobankjp.org/pgx/
Email

Sponsor
Institute	RIKEN
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science & Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Institute of Medical Science, The University of Tokyo
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2011 Year 12 Month 01 Day

Related information
URL releasing protocol	http://www.biobankjp.org/pgx/
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 11 Month 30 Day
Date of IRB	2011 Year 12 Month 06 Day
Anticipated trial start date	2011 Year 12 Month 01 Day
Last follow-up date	2014 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2011 Year 11 Month 30 Day
Last modified on	2021 Year 05 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008042