UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037238 |
|---|---|
| Receipt number | R000042444 |
| Scientific Title | Noac for Desimplanted IHD Patients Complicated with Atrial Fibrillation |
| Date of disclosure of the study information | 2019/07/02 |
| Last modified on | 2020/07/01 12:19:47 |
* 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
Noac for Desimplanted IHD Patients Complicated with Atrial Fibrillation
Acronym
NADESICO-AF Study
Scientific Title
Noac for Desimplanted IHD Patients Complicated with Atrial Fibrillation
Scientific Title:Acronym
NADESICO-AF Study
Region
| Japan |
Condition
Condition
atrial fibrillation and acute coronary syndrome and/or percutaneous coronary intervention
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the safety antiplatelet therapy in patients with atrial fibrillation and acute coronary syndrome and/or percutaneous coronary intervention
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
major and clinically relevant nonmajor bleeding
Key secondary outcomes
death, myocardial infarction, stroke, target vessel revascularization(TVR), stent thrombosis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
1 month after PCI , dual antiplatelet therapy (DAPT) with VKA plus P2Y12 inhibitor will be performed for 12 months.
Interventions/Control_2
1 month after PCI , dual antiplatelet therapy (DAPT) with apixaban plus P2Y12 inhibitor will be performed for 12 months.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Atrial fibrillation and Coronary Heart Deseiase(including cases during VKA administration)
(2)Patients undergoing coronary angioplasty with drug-eluting stent
(3)Patients with informed consent for participation in this study
Key exclusion criteria
(1)Case of atrial fibrillation due to reversible cause
(2)Patients scheduled for ablation for atrial fibrillation
(3)Cases of increased bleeding risk
(4)Patients who need anticoagulation other than atrial fibrillation
(5)Cerebral infarction within 7 days of onset
(6)Infective endocardial inflammation
(7)Mitral stenosis case
(8)Insufficient control of hypertension
(9)Cases scheduled for surgical treatment
(10)Hb<9.0g/dl or platelet count 100,000 / mm3 or less case
(11)A case with severe liver disorder
(12)A case with severe renal injury
(13)Patients who are expected to have a life expectancy of less than one year
(14)Cases already receiving NOAC
(15)
Other cases deemed inappropriate by the attending physician
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Sakamoto |
Organization
Saiseikai Kumamoto Hospital
Division name
Cardiology internal medicine
Zip code
861-4193
Address
5-3, Minami-ku, Kumamoto-shi, Kumamoto-shi, Kumamoto
TEL
096-351-8000
tomohiro-sakamoto@saiseikaikumamoto.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Sakamoto |
Organization
Saiseikai Kumamoto Hospital
Division name
Cardiology internal medicine
Zip code
861-4193
Address
5-3, Minami-ku, Kumamoto-shi, Kumamoto-shi, Kumamoto
TEL
096-351-8000
Homepage URL
tomohiro-sakamoto@saiseikaikumamoto.jp
Sponsor or person
Institute
Saiseikai Kumamoto Hospital
Institute
Department
Personal name
Funding Source
Organization
Saiseikai Headquarters
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saiseikai Kumamoto Hospital
Address
5-3-1 Chikami Minamiku Kumamoto, 861-4193 JAPAN
Tel
096-351-8000
rks@saiseikaikumamoto.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
| 2019 | Year | 07 | Month | 02 | 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
2
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
| 2015 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 02 | Day |
Last modified on
| 2020 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042444
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
