An observational study to investigate patient-reported satisfaction with apixaban when switched from warfarin in Japanese NVAF patients (AGAIN study)

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000018970
• Date of registration: 11/09/2015
• Prospective Registration: Yes
• Primary sponsor: Pfizer Japan Inc.
• Public title: An observational study to investigate patient-reported satisfaction with apixaban when switched from warfarin 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) - Patient-reported satisfaction in Japanese NVAF patients (AGAIN Study)
• Date of first enrolment: 2015/10/01
• Target sample size: 865
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021951
• Study type: Observational
• Study design: Not selected Not selected
• Phase: Not selected

Countries of recruitment

Japan

Contacts

• Name: Tomomi Imai
• Affiliation: Mebix Inc. Clinical Research Division

• Name: Motohiko Chachin
• Affiliation: Pfizer Japan Inc. Global Innovative Pharma Business, Medical Affairs

Key inclusion & exclusion criteria

Inclusion criteria:
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.

Age minimum: 20years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Non-valvular atrial fibrillation

Primary Outcome(s)

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).

Source(s) of Monetary Support

Pfizer Japan Inc.

Ethics review

Status: YES
Approval date:
Contact:

Results

• Results available: Yes
• Date Completed: 25/12/2016
• URL: https://www.dovepress.com/getfile.php?fileID=39756