UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028178 |
|---|---|
| Receipt number | 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 10:21:07 |
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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
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
koura@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032264
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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