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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032843
Receipt No. R000037456
Scientific Title Efficacy of Alirocumab in the arteriosclerotic biomarker changes after percutaneous coronary angioplasty (PCI).
Date of disclosure of the study information 2018/06/02
Last modified on 2018/06/02

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Basic information
Public title Efficacy of Alirocumab in the arteriosclerotic biomarker changes after percutaneous coronary angioplasty (PCI).
Acronym Efficacy of Alirocumab in the arteriosclerotic biomarker changes after percutaneous coronary angioplasty (PCI).
Scientific Title Efficacy of Alirocumab in the arteriosclerotic biomarker changes after percutaneous coronary angioplasty (PCI).
Scientific Title:Acronym Efficacy of Alirocumab in the arteriosclerotic biomarker changes after percutaneous coronary angioplasty (PCI).
Region
Japan

Condition
Condition coronary heart disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To explore the efficay of alirocumab in patients with acute myocardial infarction after PCI.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes assessment of myocardial remodering suppression effect after 32 to 40 weeks.
Key secondary outcomes assessment of coronary plaque imaging, serum biomarkers and coronary microcirculation after 32 to 40 weeks.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 alirocumab75mg/2weeks for 32 to 40 weeks
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with acute myocarial infarction
having
-Dyslipidemia undergoing treatment with HMG-CoA reductase inhibition
-LDL-C 100 mg/dL or more in conventional therapy
Key exclusion criteria -HMG-CoA reductase inhibitor is not used at the time of introduction
-At the time of introduction of research drugs, patients with LDL-C less than 100 mg / dL
-Contraindicated patients with HMG-CoA reductase inhibitors
-Hypersensitivity to the study drug
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyasu Uzui
Organization Faculty of Medical Sciences, University of Fukui
Division name Department of Cardiovascular Medicine
Zip code
Address 23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
TEL 0776-61-8800
Email huzui@u-fukui.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyasu Uzui
Organization Faculty of Medical Sciences, University of Fukui
Division name Department of Cardiovascular Medicine
Zip code
Address 23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
TEL 0776-61-8800
Homepage URL
Email huzui@u-fukui.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui
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
2018 Year 06 Month 02 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 Enrolling by invitation
Date of protocol fixation
2017 Year 05 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 06 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 06 Month 02 Day
Last modified on
2018 Year 06 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037456

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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