UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006794 |
|---|---|
| Receipt number | R000008042 |
| Scientific Title | Genotype-Based Warfarin Therapy (GENWAT) study |
| Date of disclosure of the study information | 2011/12/01 |
| Last modified on | 2021/05/15 15:41:34 |
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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
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/
Sponsor or person
Institute
RIKEN
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008042
