UMIN-CTR Clinical Trial

Basic information
Public title	Effect of eicosapentaenoic acid administration on apnea hypopnea index in sleep apnea patients who underwent percutaneous coronary intervention
Acronym	Effect of eicosapentaenoic acid administration on sleep apnea patients
Scientific Title	Effect of eicosapentaenoic acid administration on apnea hypopnea index in sleep apnea patients who underwent percutaneous coronary intervention
Scientific Title:Acronym	Effect of eicosapentaenoic acid administration on sleep apnea patients
Region	Japan

Condition
Condition	Sleep apnea
Classification by specialty	Medicine in general Cardiology Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of eicosapentaenoic acid administration on apnea hypopnea index in sleep apnea patients who underwent percutaneous coronary intervention.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Apnea hypopnea index (comparison between before and 6 months after administration)
Key secondary outcomes	(i) Fatty acid fraction, lipid profiles (ii) Intima-media thickness of carotid artery (iii) Cardiac functions on transthoracic echocardiography (iv) Flow-mediated dilation (FMD) (v) Neurohumoral factors (plasma renin activity, plasma aldosterone concentration, catecholamines, brain natriuretic peptide (BNP)) (vi) Systemic blood pressure, heart rate (vii) Cardiothoracic ratio (viii) Adverse cardiovascular event rate

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Oral eicosapentaenoic acid 1800 mg/day (900 mg x2)
Interventions/Control_2	No treatment
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	Sleep apnea patients who are diagnosed by apnea hypopnea index>5 on polysomnography after percutaneous coronary intervention, and also already diagnosed with dyslipidemia, with informed consent for inclusion.
Key exclusion criteria	(i) Patients who are already administered eicosapentaenoic acid at the time of polysomnography (ii) Patients with allergic reaction against eicosapentaenoic acid (iii) Patients with malignant neoplasm with life expectancy <6 months
Target sample size	100

Research contact person
Last name of lead principal investigator	1st name Kentaro Middle name Last name Jujo
Organization	Nishiarai Heart Center Hospital
Division name	Department of Cardiology
Zip code	123-0845
Address	1-12-8, Nishiarai Honcho, Adachi-ku, Tokyo, Japan
TEL	+81358380730
Email	juken1123@mac.com

Public contact
1st name of contact person	1st name Kentaro Middle name Last name Jujo
Organization	Nishiarai Heart Center Hospital
Division name	Department of Cardiology
Zip code	123-0845
Address	1-12-8 Nishiarai-honcho, Adachi-ku, Tokyo, Japan
TEL	+81358380730
Homepage URL
Email	juken1123@mac.com

Sponsor
Institute	Nishiarai Heart Center Hospital
Institute
Department

Funding Source
Organization	Nishiarai Heart Center Hospital
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	Seiwakai Medical Ethics Committee
Address	5-7-14, Nishiarai-honcho, Adachi-ku, Tokyo, Japan
Tel	+81338407111
Email	office-3@nishiarai.or.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	西新井ハートセンター病院

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 12 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	100
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	Open public recruiting
Date of protocol fixation	2015 Year 09 Month 15 Day
Date of IRB	2015 Year 09 Month 25 Day
Anticipated trial start date	2015 Year 11 Month 01 Day
Last follow-up date	2020 Year 12 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	2015 Year 10 Month 12 Day
Last modified on	2019 Year 04 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022336