UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028729 |
|---|---|
| Receipt number | R000032798 |
| Scientific Title | Effect of PCSK9 (Proprotein convertase subtilisin/kexin type 9) inhibitor on acute events in patients with acute myocardial infarction: multicenter randomized controlled trial |
| Date of disclosure of the study information | 2017/09/04 |
| Last modified on | 2023/08/14 12:20:29 |
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Basic information
Public title
Effect of PCSK9 (Proprotein convertase subtilisin/kexin type 9) inhibitor on acute events in patients with acute myocardial infarction: multicenter randomized controlled trial
Acronym
Effect of PCSK9 (Proprotein convertase subtilisin/kexin type 9) inhibitor on acute events in patients with acute myocardial infarction: multicenter randomized controlled trial
Scientific Title
Effect of PCSK9 (Proprotein convertase subtilisin/kexin type 9) inhibitor on acute events in patients with acute myocardial infarction: multicenter randomized controlled trial
Scientific Title:Acronym
Effect of PCSK9 (Proprotein convertase subtilisin/kexin type 9) inhibitor on acute events in patients with acute myocardial infarction: multicenter randomized controlled trial
Region
| Japan |
Condition
Condition
Acute myocardial infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine the effect of the acute phase use of PCSK9 inhibitor on factors that are related to arteriosclerosis after coronary intervention in patients with acute myocardial infarction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Inflammatory markers such as high sensitivity CRP,TNF alpha,PTX3 etc and sdLDL-c, Lp(a), ApoB etc.
Key secondary outcomes
Arrhythmic event or cardiovascular event within 1 month.
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
As a control group, receive standard treatment, including 2 mg of pitavastatin.
Interventions/Control_2
As a PCSK 9 inhibitor group, in addition to standard treatment, including 2 mg of pitavastatin, a PCSK9 inhibitor (Ebolocumab 140 mg) is administered immediately after admission and before discharge.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Acute myocardial infarction patients who succeeded in coronary intervention treatment within 24 hours after onset of symptoms
Key exclusion criteria
cardiogenic shock, dialysis cases, cardiopulmonary arrest, severe liver disease, active malignancy, Unable to ingest statins, patients using PCSK9 inhibitors, patients with side effects on PCSK9 inhibitors in the past , Participating in another trial, a patient who is pregnant or has a possibility of pregnancy, a patient judged inappropriate by another doctor
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Doi |
Organization
Kagawa Prefectural Central Hospital
Division name
Cardiology
Zip code
7608557
Address
1-2-1 Asahi-machi, Takamatsu, Kagawa, Japan
TEL
087-811-3333
mdoimd@gmail.com
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Doi |
Organization
Kagawa Prefectural Central Hospital
Division name
Cardiology
Zip code
7608557
Address
1-2-1 Asahi-machi, Takamatsu, Kagawa, Japan
TEL
087-811-3333
Homepage URL
mdoimd@gmail.com
Sponsor or person
Institute
Kagawa Prefectural Central Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Kagawa Prefectural Central Hospital
Address
1-2-1 Asahi-machi, Takamatsu, Kagawa, Japan
Tel
087-811-3333
chuobyoin@pref.kagawa.lg.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 | 09 | Month | 04 | 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
| 2017 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 19 | Day |
Date of closure to data entry
| 2020 | Year | 08 | Month | 15 | Day |
Date trial data considered complete
| 2020 | Year | 08 | Month | 15 | Day |
Date analysis concluded
| 2020 | Year | 08 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 18 | Day |
Last modified on
| 2023 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032798
