UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017895
Receipt number R000020733
Scientific Title Investigation on Efficacy and Safety of Apixaban in Japanese Elderly Patients: Investigator-Initiated Multicenter Prospective Cohort Study
Date of disclosure of the study information 2015/06/13
Last modified on 2020/06/17 09:05:23

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Basic information

Public title

Investigation on Efficacy and Safety of Apixaban in Japanese Elderly Patients: Investigator-Initiated Multicenter Prospective Cohort Study

Acronym

J-ELD AF (CVI ARO 5) Study

Scientific Title

Investigation on Efficacy and Safety of Apixaban in Japanese Elderly Patients: Investigator-Initiated Multicenter Prospective Cohort Study

Scientific Title:Acronym

J-ELD AF (CVI ARO 5) Study

Region

Japan


Condition

Condition

non-valvular atrial fibrillation (NVAF)

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the efficacy and safety of apixaban in Japanese elderly patients with NVAF in real-world clinical practice

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Stroke and systemic embolism
Bleeding requiring hospitalization

Key secondary outcomes

Death
Cardiovascular death
Myocardial infarction
Composite endpoints of cardiovascular death, myocardial infarction, stroke, and systemic embolism


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

Consecutive outpatients with 75 years and older receiving apixaban with a diagnosis of non-valvular atrial fibrillation

Key exclusion criteria

(1) Apixaban hypersensitivity
(2) Clinically significant bleeding
(3) River dysfunction with clotting disorder
(4) Renal dysfunction (creatinine clearance <15 mL/min)
(5) Mitral stenosis and prosthetic valve
(6) Inadequate dosage of apixaban at registration (2.5 mg twice a day for those without indications for reducing dose, or 5 mg twice a day for those with them)
(7) Patients who did not give written informed consents for this study
(8) Venous thromboembolism (deep vein thrombosis and pulmonary thromboembolism)
(9) Patients who are judged by the researchers as inadequate for this study

Target sample size

3000


Research contact person

Name of lead principal investigator

1st name #3 Masaharu Akao
Middle name #2 Takeshi Yamashita
Last name #1 Ken Okumura

Organization

#1 Hirosaki University Graduate School of Medicine
#2 The Cardiovascular Institute
#3 National Hospital Organization Kyoto Medical Center

Division name

#1 Professor, Department of Cardiology and Nephrology #2 Director #3 Department director, Department of Cardiology

Zip code

106-0031

Address

#2 3-2-19 Nishiazabu, Minato-Ku, Tokyo

TEL

+81-3-3408-2151

Email

yamt-tky@umin.ac.jp


Public contact

Name of contact person

1st name Kazumi
Middle name
Last name Matsuda

Organization

The Cardiovascular Institute Academic Organization (CVI ARO)

Division name

Head office

Zip code

106-0031

Address

3-2-19 Nishiazabu, Minato-Ku, Tokyo

TEL

03-3408-2151

Homepage URL


Email

matsuda@cvi.or.jp


Sponsor or person

Institute

The Cardiovascular Institute Academic
Organization (CVI ARO)

Institute

Department

Personal name



Funding Source

Organization

Bristol-Myers Squibb

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

United States


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethical Committee of The Cardiovascular Institute

Address

Nishi-azabu 3-2-19, Minato-ku, Tokyo

Tel

+81-3-3408-2151

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

2015 Year 06 Month 13 Day


Related information

URL releasing protocol

https://www.journal-of-cardiology.com/article/S0914-5087(15)00404-9/fulltext

Publication of results

Published


Result

URL related to results and publications

https://onlinelibrary.wiley.com/doi/full/10.1002/clc.23294

Number of participants that the trial has enrolled

3031

Results

Event rates (/100 person-years) in standard and reduced dose groups were 1.67 and 1.56, respectively, for stroke or systemic embolism, 1.42 and 2.25 for bleeding requiring hospitalization, 1.41 and 4.46 for total death, and 0.41 and 1.36 for cardiovascular death.

Results date posted

2020 Year 06 Month 17 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2019 Year 11 Month 18 Day

Baseline Characteristics

Average age, 81.7 years; female, 48.2%
Taking standard (5 mg bid) or reduced dose (2.5 mg bid) of apixaban.
Standard and reduced apixaban doses were administered in 1284 (42.4%) and 1747 (57.6%) patients, respectively.

Participant flow

A total of 3031 patients were enrolled from 110 facilities.

Adverse events

Shown in the Results above.

Outcome measures

Shown in the Results above.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 06 Month 13 Day

Date of IRB

2015 Year 08 Month 27 Day

Anticipated trial start date

2015 Year 09 Month 01 Day

Last follow-up date

2017 Year 08 Month 31 Day

Date of closure to data entry

2018 Year 01 Month 31 Day

Date trial data considered complete

2018 Year 05 Month 31 Day

Date analysis concluded



Other

Other related information

3031 patients have been registered,
and follow-up was completed


Management information

Registered date

2015 Year 06 Month 13 Day

Last modified on

2020 Year 06 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020733


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name