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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name