UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032030
Receipt number R000036453
Scientific Title Prospective randomized study of safety outcomes treated with edoxaban in patients with stable coronary artery disease and atrial fibrillation
Date of disclosure of the study information 2018/03/31
Last modified on 2020/05/01 17:00:01

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Basic information

Public title

Prospective randomized study of safety outcomes treated with edoxaban in patients with stable coronary artery disease and atrial fibrillation

Acronym

PRAEDO AF study

Scientific Title

Prospective randomized study of safety outcomes treated with edoxaban in patients with stable coronary artery disease and atrial fibrillation

Scientific Title:Acronym

PRAEDO AF study

Region

Japan


Condition

Condition

Non-valvular atrial fibrillation

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of edoxaban monotherapy compared to edoxaban in co-administration with a single anti-platelet therapy in non-valvular atrial fibrillation patients with stable coronary artery diseases.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

major bleeding
Clinically relevant non-major bleeding

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Edoxaban monotherapy
Edoxaban will be orally administered at a dose of 30 mg if the creatinine clearance (CLcr) is 50 mL/min or more and at a dose of 30 mg if the CLcr is 15-50 mL/min and at a dose of 30mg if Body weight is under 60Kg until end of study.

Interventions/Control_2

Edoxaban co-administered with plavix therapy
Edoxaban and a plavix will be orally administered until end of study.
Edoxaban will be orally administered at a dose of 30 mg if the creatinine clearance (CLcr) is 50 mL/min or more and at a dose of 30 mg if the CLcr is 15-50 mL/min and at a dose of 30mg if Body weight is under 60Kg until end of study.
Clopidogrel administration: Clopidogrel will be orally administered once a day after a meal at a dose of 75 mg.

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

Patients with non-valvular atrial fibrillation complicated with stable coronary artery disease who are 20 years or more at the obtaining of informed consent, CHADS2 score are 1 or more, and fulfil the criteria below and can provide written consent for participation in the present study will be eligible.
1) Patients who underwent percutaneous coronary intervention, including plain old balloon angioplasty, at least six months ago
2) Patients who have coronary stenosis requiring no percutaneous coronary intervention (50% or more stenosis) as indicated by coronary CT or coronary angiography
3) Patients who underwent coronary artery bypass graft CABG at least six months ago

Key exclusion criteria

1)Patients who are contraindicated for edoxaban
2)Patients who are contraindicated for clopidogrel
3)Patients who are going to undergo revascularization
4)Those who are going to undergo invasive surgery (excluding digestive endoscopy and biopsy)
5)Patients who have active tumors
6)Patients who have poorly-controlled hypertension (systolic blood pressure at hospital admission: 160 mmHg or more)
7)Patients judged as inappropriate for this study by investigators

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Daisuke Fukamachi

Organization

Nihon university school of medicine

Division name

department of cardiology

Zip code


Address

30-1 ohyaguchi-kamicho,itabashi-ku,tokyo 173-8610 japan

TEL

03-3972-8111

Email

fukamachi.daisuke@nihon-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Daisuke Fukamachi

Organization

Nihon university school of medicine

Division name

department of cardiology

Zip code


Address

30-1 ohyaguchi-kamicho,itabashi-ku,tokyo 173-8610 japan

TEL

03-3972-8111

Homepage URL


Email

fukamachi.daisuke@nihon-u.ac.jp


Sponsor or person

Institute

Nihon university school of medicine

Institute

Department

Personal name



Funding Source

Organization

Daiichi-Sankyo Company

Organization

Division

Category of Funding Organization

Profit organization

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

2018 Year 03 Month 31 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


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

Terminated

Date of protocol fixation

2018 Year 03 Month 30 Day

Date of IRB

2018 Year 03 Month 30 Day

Anticipated trial start date

2018 Year 06 Month 01 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Because the this study shifted to the jRCT/jRCTs031180119


Management information

Registered date

2018 Year 03 Month 31 Day

Last modified on

2020 Year 05 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036453


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name