UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018970
Receipt number 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 11:32:22

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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 or person

Institute

Pfizer Japan Inc.

Institute

Department

Personal name



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

Value
https://center6.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