UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053575 |
|---|---|
| Receipt number | R000061138 |
| Scientific Title | Clinical Study of Biomarker Variability with Evolocumab in Patients Undergoing Percutaneous Coronary Angioplasty (PCI) |
| Date of disclosure of the study information | 2024/02/08 |
| Last modified on | 2024/02/08 20:17:25 |
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Basic information
Public title
Very Short-Term Effects of Evolocumab in Patients Undergoing Percutaneous Coronary Angioplasty (PCI)
Acronym
Effects of Evolocumab in Patients Undergoing Percutaneous Coronary Angioplasty (PCI)
Scientific Title
Clinical Study of Biomarker Variability with Evolocumab in Patients Undergoing Percutaneous Coronary Angioplasty (PCI)
Scientific Title:Acronym
Very Short-Term Effects of Evolocumab for Coronary Artery Disease
Region
| Japan |
Condition
Condition
Ischemic Heart Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It would be useful to examine the impact of aggressive lipid management with the use of evolocumab, a novel mechanism of action, on changes to atherosclerotic foci and reduction of myocardial damage during PCI in patients with angina pectoris undergoing PCI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of biomarkier variability
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administared single dose of Evolocumab 420mg
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
coronary artery disease patients with significant stenotic lesions who performed NIRS-IVUS at the target lesions at the time of coronary angiography for diagnosis
Key exclusion criteria
We excluded patients with acute coronary syndrome, chronic total occlusion, patients who could not be followed with NIRS-IVUS
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Uzui |
Organization
University of Fukui
Division name
Department of Cardiovascular Medicine
Zip code
910-1193
Address
23-3 Shimoaizuki, Matsuoka Eiheiji-Cho, Yoshida-gun, Fukui
TEL
+81-776-61-3111
huzui@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Uzui |
Organization
University of Fukui
Division name
Department of Cardiovascular Medicine
Zip code
910-1193
Address
23-3 Shimoaizuki, Matsuoka Eiheiji-Cho, Yoshida-gun, Fukui
TEL
+81-776-61-3111
Homepage URL
huzui@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui
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
Medical Research Support Center, University of Fukui Hospital
Address
23-3 Shimoaizuki, Matsuoka Eiheiji-Cho, Yoshida-gun, Fukui
Tel
+81-776-61-3111
huzui@u-fukui.ac.jp
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
| 2024 | Year | 02 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
T.B.D
Number of participants that the trial has enrolled
Results
T.B.D
Results date posted
| 2024 | Year | 02 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
T.B.D
Adverse events
T.B.D
Outcome measures
T.B.D
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 28 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 02 | Month | 08 | Day |
Last modified on
| 2024 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061138
