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 |
* 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
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
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
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
