UMIN-CTR Clinical Trial

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
Institute	Nihon university school of medicine
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036453