UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030860 |
|---|---|
| Receipt number | 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 | 2024/01/22 15:49:26 |
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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
PCSK9 inhibitors-treated and non-treated groups
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
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
ymaekawa@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
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
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
126
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 11 | Day |
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
| 2024 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035154
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| Registered date | File name |
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