Unique ID issued by UMIN | UMIN000018970 |
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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 |
An observational study to investigate patient-reported satisfaction with apixaban when switched from warfarin in Japanese NVAF patients (AGAIN study)
Patient-reported satisfaction in Japanese NVAF patients (AGAIN Study)
An observational study to investigate patient-reported satisfaction with apixaban when switched from warfarin in Japanese NVAF patients (AGAIN study)
Patient-reported satisfaction in Japanese NVAF patients (AGAIN Study)
Japan |
Non-valvular atrial fibrillation
Cardiology | Neurology |
Others
NO
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.
Others
Study on patients-reported satisfaction with anti-coagulant therapy
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).
Observational
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
865
1st name | |
Middle name | |
Last name | Motohiko Chachin |
Pfizer Japan Inc.
Global Innovative Pharma Business, Medical Affairs
3-22-7 Yoyogi, Shibuya-ku, Tokyo 151-8589, Japan
080-3932-3402
Motohiko.Chachin@pfizer.com
1st name | |
Middle name | |
Last name | Tomomi Imai |
Mebix Inc.
Clinical Research Division
Akasaka Intercity, 1-11-44 Akasaka, Minato-ku, Tokyo, Japan 107-0052
03-6675-9911
again@mebix.co.jp
Pfizer Japan Inc.
Pfizer Japan Inc.
Self funding
NO
2015 | Year | 09 | Month | 11 | Day |
Published
https://www.dovepress.com/getfile.php?fileID=39756
Completed
2015 | Year | 08 | Month | 24 | Day |
2015 | Year | 10 | Month | 01 | Day |
2016 | Year | 12 | Month | 25 | Day |
2017 | Year | 01 | Month | 29 | Day |
2017 | Year | 02 | Month | 20 | Day |
2017 | Year | 03 | Month | 07 | Day |
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
2015 | Year | 09 | Month | 10 | Day |
2017 | Year | 12 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021951
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