UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052960 |
|---|---|
| Receipt number | R000060424 |
| Scientific Title | An Exploratory Clinical Study of Alirocumab in Patients Undergoing Percutaneous Coronary Angioplasty (PCI) for Biomarker Variability Related to Atherosclerotic Disease |
| Date of disclosure of the study information | 2023/12/01 |
| Last modified on | 2024/06/07 16:00:23 |
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Basic information
Public title
Clinical research on aggressive lipid lowering therapy after catheterization
Acronym
Clinical research on aggressive lipid lowering therapy
Scientific Title
An Exploratory Clinical Study of Alirocumab in Patients Undergoing Percutaneous Coronary Angioplasty (PCI) for Biomarker Variability Related to Atherosclerotic Disease
Scientific Title:Acronym
Clinical Studies on Alirocumab for Coronary Artery Disease
Region
| Japan |
Condition
Condition
Acute coronary syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the impact of alirocumab as a lipid-lowering treatment on the prognosis of patients with acute coronary syndrome who have undergone percutaneous coronary intervention (PCI).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of biomarker variability (LDL, MMP9, PTX3, hs-CRP, TNF-alpha, L-arginine/ADMA Ratio, PCSK9 assessed at emergency PCI, 2 weeks, and 32-40 weeks post PCI)
Key secondary outcomes
Evaluation of vulnerable plaque (assessed by coronary angioscopy at 32-40 weeks post PCI)
Inhibition of myocardial remodeling (evaluated by echocardiography within 48 hours and at 32-40 weeks post PCI)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Patients with dyslipidemia treated with statins
Patients with LDL-C of 100 mg/dL or higher even with conventional therapy at the time of introduction of the drug used.
Key exclusion criteria
Patients who are already receiving a drug of the same type or a drug already being used before enrollment in the study.
Patients who are not taking statin
Patients with LDL-C less than 100 mg/dL
Patients with contraindications to statins requiring concomitant use
Patients with a history of hypersensitivity to any component of the drug used
Patients whom the attending physician deems inappropriate for participation in the study on medical grounds
Patients who are pregnant, lactating, may be pregnant, or wish to become pregnant during the study period.
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 Resaerch Support Center, University of Fukui Hospital
Address
23-3, shimoaizuki, matsuoka, eiheiji-cho, yoshida-gun, Fukui, Japan
Tel
0776-61-8529
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
| 2023 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
T.B.D
Publication of results
Unpublished
Result
URL related to results and publications
T.B.D
Number of participants that the trial has enrolled
43
Results
T.B.D
Results date posted
| 2023 | Year | 11 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
T.B.D
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective, single-center cohort study
Management information
Registered date
| 2023 | Year | 11 | Month | 30 | Day |
Last modified on
| 2024 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060424
