UMIN-CTR Clinical Trial

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
Email	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
Email	tomohiro-sakamoto@saiseikaikumamoto.jp

Sponsor
Institute	Saiseikai Kumamoto Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042444