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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028730
Receipt No. R000032799
Scientific Title Effect of PCSK9 (Proprotein convertase subtilisin/kexin type 9) inhibitor on long term outcomes in patients with acute myocardial infarction: multicenter randomized controlled trial
Date of disclosure of the study information 2017/09/04
Last modified on 2017/08/18

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Basic information
Public title Effect of PCSK9 (Proprotein convertase subtilisin/kexin type 9) inhibitor on long term outcomes in patients with acute myocardial infarction: multicenter randomized controlled trial
Acronym Effect of PCSK9 (Proprotein convertase subtilisin/kexin type 9) inhibitor on long term outcomes in patients with acute myocardial infarction: multicenter randomized controlled trial
Scientific Title Effect of PCSK9 (Proprotein convertase subtilisin/kexin type 9) inhibitor on long term outcomes in patients with acute myocardial infarction: multicenter randomized controlled trial
Scientific Title:Acronym Effect of PCSK9 (Proprotein convertase subtilisin/kexin type 9) inhibitor on long term outcomes 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 secondary preventive effect of acute phase use of PCSK9 inhibitors 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 Progression of coronary lesion after 8 months (QCA, with or without rapid progression)
Key secondary outcomes Cardiovascular death, non-fatal myocardial infarction, stroke, and intervention for de novo coronary lesions

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
Middle name
Last name Masayuki Doi
Organization Kagawa Prefectural Central Hospital
Division name Cardiology
Zip code
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
Middle name
Last name Masayuki Doi
Organization Kagawa Prefectural Central Hospital
Division name Cardiology
Zip code
Address 1-2-1 Asahi-machi, Takamatsu, Kagawa, Japan
TEL 087-811-3333
Homepage URL
Email mdoimd@gmail.com

Sponsor
Institute Kagawa Prefectural Central Hospital
Institute
Department

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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2017 Year 06 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 04 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
2017 Year 08 Month 18 Day
Last modified on
2017 Year 08 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032799

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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