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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000024006
Receipt No. R000027432
Scientific Title Prospective Observational Study in Late-Stage Elderly Patients with Non-Valvular Atrial Fibrillation All Nippon AF In Elderly Registry -ANAFIE Registry-
Date of disclosure of the study information 2016/09/12
Last modified on 2021/12/01

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Basic information
Public title Prospective Observational Study in Late-Stage Elderly Patients with Non-Valvular Atrial Fibrillation
All Nippon AF In Elderly Registry
-ANAFIE Registry-
Acronym ANAFIE Registry
Scientific Title Prospective Observational Study in Late-Stage Elderly Patients with Non-Valvular Atrial Fibrillation
All Nippon AF In Elderly Registry
-ANAFIE Registry-
Scientific Title:Acronym ANAFIE Registry
Region
Japan

Condition
Condition Non-Valvular Atrial Fibrillation
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The major objectives of this study are to elucidate the current status of, and prognosis under, anticoagulant therapy as well as to determine the risk factors for stroke/systemic embolism and intracranial hemorrhage in late-stage elderly patients (aged 75 years or more) with non-valvular atrial fibrillation (NVAF) to identify the best-suited patient population and the optimal dosing regimen for DOACs.
Basic objectives2 Others
Basic objectives -Others The secondary objective of this study is to address various clinical questions related to NVAF.
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Development of stroke/systemic embolism during the observation period
Key secondary outcomes Occurrence of the following events during the observation period:
(1)Hemorrhagic adverse events (major bleeding)
(2)Stroke
(3)Systemic embolism
(4)Ischemic stroke
(5)Hemorrhagic stroke
(6)Intracranial hemorrhage
(7)Cardiovascular events (stroke, myocardial infarction, cardiac intervention for cardiac events other than myocardial infarction, or heart failure requiring hospitalization)
(8)Death from cardiovascular disease (death for which possibility of causal relationship with any cardiovascular factor cannot be excluded)
(9)All-cause mortality

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
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1)Patients who have been given the definitive diagnosis of NVAF and who have the ability to attend the hospital at specified visits. If a new diagnosis of NVAF is to be given to a patient, ECG, Holter ECG, portable ECG, echocardiography, etc. should be performed to make a definitive diagnosis.
(2)Patients aged 75 years or more at the time of informed consent (male or female patients)
(3)Patients who have given informed consent in writing
Key exclusion criteria (1)Patients who are currently participating/who are planning to participate in an interventional study
(2)Patients who have been given the definitive diagnosis of mitral stenosis
(3)Patients who have an artificial heart valve (mechanical valve or tissue valve prostheses) in their body
(4)Patients who have experienced any cardiovascular event (stroke, myocardial infarction, cardiac intervention for cardiac events other than myocardial infarction, or heart failure requiring hospitalization) or any bleeding leading to hospitalization within one month before enrollment
(5)Patients who have been diagnosed as having a life expectancy of less than one year for some kind of disease
(6)Patients for whom participation in this study is inappropriate for other reason than those mentioned in the exclusion criteria above
Target sample size 30000

Research contact person
Name of lead principal investigator
1st name Takeshi
Middle name
Last name Yamashita
Organization The Cardiovascular Institute
Division name Director
Zip code 106-0031
Address 3-2-19 Nishi-azabu, Minato-ku, Tokyo 106-0031
TEL 03-3408-2151
Email ANAFIE_office@quintiles.com

Public contact
Name of contact person
1st name Yoshiro
Middle name
Last name Hirano
Organization IQVIA Services Japan K.K.
Division name Real World & Late Phase Research
Zip code 5320003
Address Nissay Shin-Osaka Bldg, 3-4-30 Miyahara, Yodogawa-ku, Osaka 532-0003
TEL 06-7668-9053
Homepage URL http://www.anafie.net/
Email ANAFIE_office@quintiles.com

Sponsor
Institute Medical Science Department
Daiichi Sankyo Company, Limited.
Institute
Department

Funding Source
Organization Medical Science Department
Daiichi Sankyo Company, Limited.
3-5-1 Nihonbashi-honcho
Chuo-ku, Tokyo 103-8426
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Cardiovascular Institute Ethic committee
Address 3-2-19 Nishi-azabu, Minato-ku, Tokyo 106-0031
Tel 03-3408-2151
Email matsuda@cvi.or.jp

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
2016 Year 09 Month 12 Day

Related information
URL releasing protocol https://pubmed.ncbi.nlm.nih.gov/29625717/
Publication of results Published

Result
URL related to results and publications https://academic.oup.com/ehjqcco/advance-article/doi/10.1093/ehjqcco/qcab025/6208893?searchresult=1
Number of participants that the trial has enrolled 33062
Results Among 32275 patients included in the analysis, 2445 (7.6%) were not receiving oral anticoagulants (OACs) and 29830 (92.4%) were given OACs. Of these, 21585 (66.9%) were receiving direct OACs (DOACs) and 8233 (25.5%), warfarin. The 2-year incidence rates were 3.01% for stroke/systemic embolic events (SEE); 2.00%, major bleeding; and 6.95%, all-cause death. The hazard ratios of DOAC group vs warfarin group were lower for stroke/SEE, major bleeding, and all-cause death after adjusting for confounders.
Results date posted
2021 Year 12 Month 01 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2021 Year 04 Month 02 Day
Baseline Characteristics Overall, 57.3% of patients were men, the mean body mass index (BMI) was 23.3?kg/m2, and the mean age was 81.5?years. Most patients were between 75 and 79?years of age (40.0%) or between 80 and 89?years of age (43.5%), and 6.5% were aged over 90?years. Paroxysmal AF was the most common type of AF, followed by persistent AF and long-standing persistent/permanent AF. The most common comorbidities were hypertension (75.3%) and heart failure (37.5%).
Of 32275 patients, 12 were using parenteral anticoagulants and were therefore excluded from further analyses according to types of anticoagulation. In total, 2445 (7.6%) patients were not receiving OACs (No OAC group), and 29830 (92.4%) were receiving OACs (OAC group). Of the latter, 8233 (25.5%) were using warfarin, and 21585 (66.9%) were using DOACs. In the warfarin group, the mean prothrombin time-international normalized ratio was 1.98 at enrolment, and the mean time in the therapeutic range (PT-INR 1.6-2.6) was 75.5% during the 6?months just before the enrolment. In the DOAC group, apixaban, rivaroxaban, edoxaban, and dabigatran was used in 8045 (24.9% of the total), 6403 (19.8%), 4790 (14.8%), and 2347 (7.3%) patients, respectively. The percentage of patients prescribed a reduced dose of each DOAC was 61.1%, and 27.5% of those were treated with doses below those recommended in the package insert.
The mean age of the No OAC group was the highest, followed in order by the warfarin and DOAC groups. Patients receiving DOACs tended to have a higher creatinine clearance and tended to be more frequently diagnosed with paroxysmal AF than warfarin groups. Patients using warfarin tended to have higher proportions of heart failure, diabetes mellitus, chronic kidney disease, and MI than those in the No OAC and DOAC groups. Non-pharmacological therapy for AF, including catheter ablation was more common in the No OAC group.
Participant flow Of the 33062 patients enrolled, 787 were excluded, and a total of 32275 patients were included in the present analysis. There were 1109 (3.4%) patients lost to follow-up; the proportion did not differ among the No OAC, warfarin, and DOAC groups (P= 0.29). Meanwhile, 762 (2.4%) discontinued the study due to withdrawal of consent and other reasons; the proportion of patients who discontinued differed slightly but significantly among the three treatment groups (P= 0.005). The mean follow-up period was 1.88 years.
Adverse events data not shown
Outcome measures In total, the 2-year incidence rate was 3.01% for stroke/systemic embolic events (SEE); 2.00%, major bleeding; and 6.95%, all-cause death. When compared with the warfarin group, the DOAC group had a lower hazard ratio (HR) for stroke/SEE, major bleeding, and all-cause death after adjusting for confounders. The group without OACs had a higher HR for stroke/SEE and all-cause death, with a lower HR for major bleeding. History of falls within 1 year at enrolment and of catheter ablation were positive and negative independent risk factors, respectively, for stroke/SEE, major bleeding, and all-cause death.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2016 Year 06 Month 23 Day
Date of IRB
2016 Year 08 Month 02 Day
Anticipated trial start date
2016 Year 10 Month 01 Day
Last follow-up date
2020 Year 01 Month 31 Day
Date of closure to data entry
2020 Year 05 Month 18 Day
Date trial data considered complete
2020 Year 05 Month 31 Day
Date analysis concluded

Other
Other related information Multicenter Prospective Observational Study

Management information
Registered date
2016 Year 09 Month 12 Day
Last modified on
2021 Year 12 Month 01 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027432

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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