UMIN-CTR Clinical Trial

Basic information
Public title	Effect of polysaturated fatty acids on vascular healing process in hyper-cholesterolemic patients with acute coronary syndrome
Acronym	Effect of PUFA on vascular healing process in hypercholesterolemic patients with ACS
Scientific Title	Effect of polysaturated fatty acids on vascular healing process in hyper-cholesterolemic patients with acute coronary syndrome
Scientific Title:Acronym	Effect of PUFA on vascular healing process in hypercholesterolemic patients with ACS
Region	Japan

Condition
Condition	acute coronary syndrome
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the effect of 2 types of PUFA on vascular healing process using optical coherence tomography
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in OCT parameter at 8-month follow-up 1) thickness of fibrous cap at non-culprit lipid rich plaque 2) condition of neointimal coverage over implanted stent
Key secondary outcomes	Changes in following paremter at 8-month follow-up 1) lipid core size (OCT) 2) serum plasma profile 3) changes in inflammatory parameters 4) relation between lipid core size and serum lipid profile Changes in following paremter at 12-month follow-up 5) serum lipid profile 6) development of adverse cardiovascular events

Base
Study type	Interventional

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

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Standard lipid lowering therapy with statins. LDL level less than 100mg/dl
Interventions/Control_2	Intensive lipid lowering theraphy with both statin and EPA
Interventions/Control_3	Intensive lipid lowering theraphy with both statin and EPA+DHA
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	Patients meeting all of the following criteria will be included. 1) ACS patients who have received successful OCT-guided PCI 2) Patients who tolerate statin 3) written concent for participation
Key exclusion criteria	Patients meeting all of the following criteria will be excluded. 1) patients who had been taking EPA or EPA+DHA before enrollment 2) bleeding tendency 3) hypersensitivity for EPA or EPA+DHA 4) congestive heart failure 5) refractory unstable angina 6) participating other clinical trials 7) pregnant, lactating, and possibly pregnant women and those planning to become pregnant 8) judged as ineligible by clinical investigators
Target sample size	180

Research contact person
Name of lead principal investigator	1st name Makoto Middle name Last name Watanabe
Organization	Nara Medical University
Division name	Department of Cardiovascular Medicine
Zip code	6348522
Address	840 Shijo-cho, Kashihara, Nara 634-8522, Japan
TEL	0744-22-3051
Email	wmakoto07@kcn.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Watanabe
Organization	Nara Medical University
Division name	Department of Cardiovascular Medicine
Zip code	6348522
Address	840 Shijo-cho, Kashihara, Nara, Japan
TEL	0744-22-3051
Homepage URL
Email	wmakoto07@kcn.jp

Sponsor
Institute	Department of Cardiovascular Medicine Nara Medical University
Institute
Department

Funding Source
Organization	Department of Cardiovascular Medicine Nara Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nara Medical University Hospital Institutional Review Board
Address	840,Shijo-cho,Kashihara-city,Nara
Tel	0744-22-3051
Email	ychiken@naramed-u.ac.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	奈良県立医科大学附属病院，循環器・腎臓・代謝内科，およびその関連病院（県立奈良病院，県立三室病院，市立奈良病院，済生会吹田病院） Nara Medical Universtity hospital, Nara prefectural hospital, Mimuro hospital, Nara City hospital, Saiseikai Suita hospital

Other administrative information
Date of disclosure of the study information	2014 Year 02 Month 01 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	Completed
Date of protocol fixation	2013 Year 12 Month 24 Day
Date of IRB	2014 Year 01 Month 16 Day
Anticipated trial start date	2014 Year 02 Month 01 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry	2019 Year 06 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 01 Month 11 Day
Last modified on	2020 Year 06 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014981