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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030860
Receipt No. R000035154
Scientific Title To clarify the action mechanism of anti-PCSK9 antibody therapy for acute coronary syndrome
Date of disclosure of the study information 2018/03/01
Last modified on 2019/03/14

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Basic information
Public title To clarify the action mechanism of anti-PCSK9 antibody therapy for acute coronary syndrome
Acronym To clarify the action mechanism of anti-PCSK9 antibody therapy for acute coronary syndrome
Scientific Title To clarify the action mechanism of anti-PCSK9 antibody therapy for acute coronary syndrome
Scientific Title:Acronym To clarify the action mechanism of anti-PCSK9 antibody therapy for acute coronary syndrome
Region
Japan

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

Objectives
Narrative objectives1 To clarify the effect of anti-PCSK9 antibody therapy on acute coronary syndrome
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Major adverse Cardiac and Cerebrovascular Events (all cause death, cardiovascular death, cerebrovascular accident, coronary revascularization etc)
Key secondary outcomes

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 anti-PCSK9 antibody therapy
Interventions/Control_2 3months
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 a serum LDL-C level more than 70mg/dl, acute coronay syndrome, PCI with drug-eluting stent, age more than 20, participants have a statin
Key exclusion criteria significant liver dysfunction(ALT more than 100 U/L), serum creatinine level more than 3 mg/dl, end-stage renal disease, a pregnancy or inability to provide written informed consent, Participants had already had anti-PCSK9 antibody on admission, participants had serious complication of PCI
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Yuichiro
Middle name
Last name Maekawa
Organization Hamamatsu University School of Medicine
Division name Internal Medicine III
Zip code 431-3192
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan
TEL 0534352111
Email ymaekawa@hama-med.ac.jp

Public contact
Name of contact person
1st name Yuichiro
Middle name
Last name Maekawa
Organization Hamamatsu University School of Medicine
Division name Internal Medicine III
Zip code 431-3192
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan
TEL 0534352111
Homepage URL
Email ymaekawa@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization self funding
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 Hamamatsu University School of Medicine IRB
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan
Tel 053-435-2680
Email rinri@hama-med.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 浜松赤十字病院(静岡県浜松市)
富士宮市立病院(静岡県富士宮市)
菊川市立総合病院(静岡県菊川市)
聖隷三方原病院(静岡県浜松市)
磐田市立総合病院(静岡県磐田市)
JA静岡厚生連遠州病院(静岡県浜松市)
市立湖西病院(静岡県湖西市)
浜松医療センター(静岡県浜松市)
静岡市立静岡病院(静岡県静岡市)
しらさきクリニック(埼玉県久喜市)

Other administrative information
Date of disclosure of the study information
2018 Year 03 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 Open public recruiting
Date of protocol fixation
2017 Year 12 Month 11 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 01 Month 17 Day
Last modified on
2019 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035154

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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