UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000028178
Receipt No. R000032264
Scientific Title Effects of Evolocumab on carotid plaque.
Date of disclosure of the study information 2017/08/01
Last modified on 2019/07/13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effects of Evolocumab on carotid plaque.
Acronym Effects of Evolocumab on carotid plaque.
Scientific Title Effects of Evolocumab on carotid plaque.
Scientific Title:Acronym Effects of Evolocumab on carotid plaque.
Region
Japan

Condition
Condition carotid plaque
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluating the effects of evolocumab on carotid plaque.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in IMT from baseline to week 48.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral administration of statins with maximum tolerated dose for 48 weeks.
Interventions/Control_2 Subcutaneous administration of evolocumab 140 mg once every two weeks for 48 weeks.
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) 20 years and over
2) History of non cardiogenic cerebral infarction
3) IMT >= 1.1 mm
4) Sttains have been administered for 3 months or longer with maximum tolerated dose without changes in dose.
5) LDL-C >= 120 mg/dL
Key exclusion criteria 1) History of coronary artery disease or valvular disease or heart failure of NYHA class 3 or higher
2) Arrhythmia with poor control within 3 months
3) High blood pressure with poor control(systolic blood pressure at rest > 180 mmHg)
4) Type 1 diabetes or poorly controlled diabetes (HbA1c > 9.0 %)
5) Creatine kinase is at least 3 times higher than normal upper limit.
6) History of PCSK9 inhibitor administration in the past.
7) History of administration of cyclosporine and steroid for more than 2 weeks within 3 months before entry of the study.
8) History of malignant tumor.
9) Active infectious diseases, renal failure, blood diseases, gastrointestinal diseases and metabolic diseases oher than diabetes / dyslipidemia
10) Pregnancy
11) Inability to evaluate by carotid ultrasonography by calcification.
12) Other conditions which the physician deems inappropriate.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuo Terayama
Organization Iwate Medical University
Division name Department of Internal medicine, Division of Neurology and Gerontology
Zip code
Address 19-1, Uchimaru, Morioka, Iwate
TEL 019-651-5111
Email teray@iwate-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazumasa Oura
Organization Iwate Medical University
Division name Department of Internal medicine, Division of Neurology and Gerontology
Zip code
Address 19-1, Uchimaru, Morioka, Iwate
TEL 019-651-5111
Homepage URL
Email koura@iwate-med.ac.jp

Sponsor
Institute Iwate Medical University
Institute
Department

Funding Source
Organization Iwate Medical University
Organization
Division
Category of Funding Organization Other
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 08 Month 01 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 Terminated
Date of protocol fixation
2017 Year 07 Month 10 Day
Date of IRB
2017 Year 07 Month 06 Day
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 11 Day
Last modified on
2019 Year 07 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032264

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.