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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026516
Receipt No. R000030449
Scientific Title Acute Effect of Short-term of PCSK9 antibody Usage on Coronary Plaque Stability in Japanese Okinawan Acute coronary Patients by Optical Coherence Tomography analysis
Date of disclosure of the study information 2017/03/13
Last modified on 2019/03/15

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Basic information
Public title Acute Effect of Short-term of PCSK9 antibody Usage on Coronary Plaque Stability in Japanese Okinawan Acute coronary Patients by Optical Coherence Tomography analysis
Acronym Adage-Joto study
Scientific Title Acute Effect of Short-term of PCSK9 antibody Usage on Coronary Plaque Stability in Japanese Okinawan Acute coronary Patients by Optical Coherence Tomography analysis
Scientific Title:Acronym Adage-Joto study
Region
Japan

Condition
Condition The acute coronary syndrome patients with dyslipidemia who undewent percutanous coronary intervention.
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Assessment of acute efficacy of short-term of PCSK9 antibody usage on coronary plaque stability in acute coronary syndrome patients by optical coherence tomography analysis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of fibrous cap thickness at 3 month follow-up OCT
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
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 PCSK9antibody
twice/month for 3months
+atrvastatin 20mg/day
Interventions/Control_2 atrvastatin 20mg/day
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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1)The age is more than 20 years old
2)acute coronary syndrome patients
3)medical history of dyslipidemia
4)LDL-C>70mg after atrvastatin(20mg)treatment
5) to get initial success of Percutanous cotonary intervension(PCI)
6)Existence of fibrous cap with lipid-rich plaque in the non-culprit lesion
7) capable of follow-up OCT at baseline,3month and 9month follow-up
Key exclusion criteria 1) The patients previously used PCSK9 antibody
2)the patient with Hemodialysis and renal insufficiency
3)severe heart failure(NYHA>3)
4)contraindication and intolerance for statin
5)contraindication for PCSK9 antibody
6)Use of other lipid-lowering therapy(ezetimib,DHA,EPA)
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Hiroki
Middle name
Last name Uehara
Organization Urasoe general hospital
Division name Cardiovascular center
Zip code 9012132
Address 4-16-1,Urasoe city,Okinawa
TEL 098-878-0231
Email cardioexpham1225@hotmail.com

Public contact
Name of contact person
1st name Hiroki
Middle name
Last name Uehara
Organization Urasoe general hospital
Division name cardiovascular center
Zip code 9012132
Address 4-16-1,Urasoe city,Okinawa
TEL 098-878-0231
Homepage URL
Email cardioexpham1225@hotmail.com

Sponsor
Institute Urasoe general hospital
Institute
Department

Funding Source
Organization none
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 Urasoe general hospiral Insitute review board
Address 4-16-1,Iso Urasoe city,Okinawa
Tel 098-878-0231
Email kenkyu@jin-aikai.xsrv.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
2017 Year 03 Month 13 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 Open public recruiting
Date of protocol fixation
2017 Year 03 Month 07 Day
Date of IRB
2017 Year 03 Month 07 Day
Anticipated trial start date
2017 Year 03 Month 13 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 11 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 13 Day
Last modified on
2019 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030449

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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