UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	PGx-based anti-coagulant therapy with Warfarin Dosing
Title of the study (Brief title)	P-ACTWAD
Region	Japan

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

Objectives
Narrative objectives1	Evaluate the genotype-based dosing algorithm for warfarin in anti-coagulant therapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Duration required for determination of stable maintenance dose. (The number of visits to the hospital and the changes in dose from initial to final dose until reaching the target INR (1.8 to 3.0) for the second time in a row.)
Key secondary outcomes	1)The bleeding events or thromboembolic events. 2)Any other adverse clinical events. 3)The number of adjustment of warfarin dose.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
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	Determine the initial dose by the genotype-based algorithm (intervention group)
Interventions/Control_2	Initiation of warfarin treatment at 1.5 mg/day. (control group)
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Patients who will take warfarin. 2) Patients who are 20-80 years old. 3) Patients who will voluntarily give written an informed consent.
Key exclusion criteria	1) Patients who have taken warfarin before. 2) Patients who urgently have to start anti-coagulant therapy. 3) Patients with a history of the prosthetic valve replacement. 4) Patients for whom target INR 2.0-3.0 are inadequate. 5) Patients with a severe hepatic or renal disorder. 6) Patients with thyroid dysfunction. 7) Patients who are applicable to contraindication to warfarin therapy. 8) Patients who take medicines that interact with warfarin. 9) Patients who cannot understand or practice the dietary instruction. 10) Patients judged by investigators as ineligible for study enrollment.
Target sample size	300

Research contact person
Name of lead principal investigator	Shinpei Nonen
Organization	Hyogo University of Health Sciences
Division name	School of Pharmacy
Address	1-3-6 Minatojima, Chuo-ku, Kobe, Hyogo
TEL	078-304-3149
Email	nonen@huhs.ac.jp

Public contact
Name of contact person	Shinpei Nonen
Organization	Hyogo University of Health Science
Division name	School of Pharmacy
Address	1-3-6, Minatojima Chuo-ku, Kobe, Hyogo
TEL	078-304-3149
Homepage URL
Email	nonen@huhs.ac.jp

Sponsor
Institute	Hyogo University of Health Sciences
Institute
Department

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

Other related organizations
Co-sponsor	Osaka City University Hyogo College of Medicine
Name of secondary funｄer(s)

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	2012 Year 04 Month 03 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 01 Month 11 Day
Anticipated trial start date	2012 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 04 Month 02 Day
Last modified on	2017 Year 04 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009013