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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018970
Receipt No. R000021951
Scientific Title An observational study to investigate patient-reported satisfaction with apixaban when switched from warfarin in Japanese NVAF patients (AGAIN study)
Date of disclosure of the study information 2015/09/11
Last modified on 2017/12/25

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Basic information
Public title An observational study to investigate patient-reported satisfaction with apixaban when switched from warfarin in Japanese NVAF patients (AGAIN study)
Acronym Patient-reported satisfaction in Japanese NVAF patients (AGAIN Study)
Scientific Title An observational study to investigate patient-reported satisfaction with apixaban when switched from warfarin in Japanese NVAF patients (AGAIN study)
Scientific Title:Acronym 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
1st name
Middle name
Last name Motohiko Chachin
Organization Pfizer Japan Inc.
Division name Global Innovative Pharma Business, Medical Affairs
Zip code
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
1st name
Middle name
Last name Tomomi Imai
Organization Mebix Inc.
Division name Clinical Research Division
Zip code
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)

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
2015 Year 09 Month 11 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.dovepress.com/getfile.php?fileID=39756
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
2015 Year 08 Month 24 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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