UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An observational study to investigate patient-reported satisfaction with apixaban when switched from warfarin in Japanese NVAF patients (AGAIN study)
Title of the study (Brief title)	Patient-reported satisfaction in Japanese NVAF patients (AGAIN Study)
Region	Japan

Condition
Condition	Non-valvular atrial fibrillation
Classification by specialty	Cardiology Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Since patients always undergo food restriction and regular monitoring of PT-INR during therapy with warfarin, switch of an anticoagulant from warfarin to apixaban might reduce their burden, improve patients' satisfaction with anticoagulant therapy and consequently improve adherence to an anticoagulant medication. However there are few data regarding patients' satisfaction with prescribed anticoagulants in Japanese. Data showing patient-reported satisfaction might be very important for every physician when they decide which anticoagulant is prescribed. The research question is whether switch from warfarin to apixaban would improve patient-reported satisfaction in NVAF patients. The objective is to evaluate improvement of patient-reported satisfaction when an anticoagulant is switched from warfarin to apixaban in NVAF patients.
Basic objectives2	Others
Basic objectives -Others	Study on patients-reported satisfaction with anti-coagulant therapy
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1.Changes in patient satisfaction from at 12 weeks after switching to apixaban from baseline, assessed by using ACTS (Burdens). 2.Changes in patient satisfaction at 12 weeks after switching to apixaban from baseline, assessed by using ACTS (Benefits).
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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.Male or female subjects with age >= 20 years 2.Patients with non-valvular atrial fibrillation necessary to be treated with an anticoagulant for prevention of ischemic stroke and systemic embolism; 3.Patients treated with warfarin at least for 8 weeks, who agree to switch from warfarin to apixaban 4.Patients who have never been treated with any NOAC including apixaban 5.Patients who provide written informed consent.
Key exclusion criteria	1.Patients whose warfarin is switched to apixaban at the timing of invasive procedures other than catheter ablation for treatment of AF. 2.Patients with a history of hypersensitivity to the active substance (apixaban) or to any of the excipients of this drug 3.Patients with clinically significant active bleeding. (judged by a physician in charge of the patients) 4.Patients with hepatic disease associated with coagulopathy and clinically relevant bleeding risk. (judged by a physician in charge of the patients) 5.Patients with renal failure (creatinine clearance <15 mL/min) (No clinical experience) 6.Patients who are not able to answer to the questionnaires.
Target sample size	865

Research contact person
Name of lead principal investigator	Motohiko Chachin
Organization	Pfizer Japan Inc.
Division name	Global Innovative Pharma Business, Medical Affairs
Address	3-22-7 Yoyogi, Shibuya-ku, Tokyo 151-8589, Japan
TEL	080-3932-3402
Email	Motohiko.Chachin@pfizer.com

Public contact
Name of contact person	Tomomi Imai
Organization	Mebix Inc.
Division name	Clinical Research Division
Address	Akasaka Intercity, 1-11-44 Akasaka, Minato-ku, Tokyo, Japan 107-0052
TEL	03-6675-9911
Homepage URL
Email	again@mebix.co.jp

Sponsor
Institute	Pfizer Japan Inc.
Institute
Department

Funding Source
Organization	Pfizer Japan Inc.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2015 Year 09 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 24 Day
Anticipated trial start date	2015 Year 10 Month 01 Day
Last follow-up date	2016 Year 12 Month 25 Day
Date of closure to data entry	2017 Year 01 Month 29 Day
Date trial data considered complete	2017 Year 02 Month 20 Day
Date analysis concluded	2017 Year 03 Month 07 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.dovepress.com/getfile.php?fileID=39756
Results
Other related information	1) Eligible patients who visit participating institutions during October 1st, 2015 - September 30th, 2016 are asked for participation into this study and only the patients providing the informed consent will be registered. 2) observational period: 3 months 3) investigation of patient-reported satisfaction with anti-coagulant therapy will be conducted at baseline and 3 months after enrollment. Changes in patients' satisfaction are studied by before-after comparison. 4) study design: single-arm, before-after comparison

Management information
Registered date	2015 Year 09 Month 10 Day
Last modified on	2017 Year 12 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021951