UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of Evolocumab in patients with arteriosclerosis obliterans.
Title of the study (Brief title)	Efficacy of Evolocumab in patients with arteriosclerosis obliterans.
Region	Japan

Condition
Condition	arteriosclerosis obliterans
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To explore the efficay of evolocumab in patients with arteriosclerosis obliterans.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the ratio of lower limb amputation after 48 weels
Key secondary outcomes

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	evolocumab140mg/2weeks for 48 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 arteriosclerosis obliterans 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	20

Research contact person
Name of lead principal investigator	Hiroyasu Uzui
Organization	Faculty of Medical Sciences, University of Fukui
Division name	Department of Cardiovascular Medicine
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	Hiroyasu Uzui
Organization	Faculty of Medical Sciences, University of Fukui
Division name	Department of Cardiovascular Medicine
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 01 Month 25 Day
Anticipated trial start date	2018 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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=R000037458