UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000032030
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.