UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012825 |
|---|---|
| Receipt number | R000014981 |
| Scientific Title | Effect of polysaturated fatty acids on vascular healing process in hyper-cholesterolemic patients with acute coronary syndrome |
| Date of disclosure of the study information | 2014/02/01 |
| Last modified on | 2020/06/10 16:58:53 |
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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
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
wmakoto07@kcn.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine
Nara Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014981
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