UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049231 |
|---|---|
| Receipt number | R000055755 |
| Scientific Title | Impact of Aggressive Lipid-Lowering Therapy with Evolocumab on Peripheral Atherosclerotic Plaque Assessed with NIRS-IVUS in Patients with Peripheral Artery Disease |
| Date of disclosure of the study information | 2022/11/01 |
| Last modified on | 2022/10/16 13:53:19 |
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Basic information
Public title
Impact of Aggressive Lipid-Lowering Therapy with Evolocumab on Peripheral Atherosclerotic Plaque Assessed with NIRS-IVUS in Patients with Peripheral Artery Disease
Acronym
RESOLVE PAD
Scientific Title
Impact of Aggressive Lipid-Lowering Therapy with Evolocumab on Peripheral Atherosclerotic Plaque Assessed with NIRS-IVUS in Patients with Peripheral Artery Disease
Scientific Title:Acronym
RESOLVE PAD
Region
| Japan |
Condition
Condition
Peripheral artery disease
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to exmine impact of aggressive lipid-lowering therapy with Evolocumab on peripheral atherosclerotic plaque evaluated with Near-infrared spectroscopy-Intravascular ultrasound (NIRS-IVUS).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The amount of change in max LCBI4mm from baseline to the 12-month follow-up
Key secondary outcomes
1)The change in lipid-core plaque distribution from baseline to the 12-month follow-up
2)The changes in total atheroma volume and percent atheroma volume from baseline to the 12-month follow-up
3)The change in minimum lumen area from baseline to the 12-month follow-up
4) Amputation-free survival at the 12-month follow-up
5) limb salvage rate at the 12-month follow-up
6) MALE (major adverse limb events) at the 12-month follow-up
7)MACE (major adverse cardiovascular events) at the 12-month follow-up
8) Revascularization rate at the 12-month follow-up
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
In the Evolocumab group, patitents will be treated with Evolocumab 140mg every 2 week or 420 mg every 4 week until 48 weeks.
Interventions/Control_2
Control group
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Patients with peripheral artery disease recieved endovascular therapy
(2)Patients who have an LDL cholesterol level of 70 mg/dL or higher treated with maximum statin therapy
(3)Presence of mild to moderate stenosis (25-75%)
(4)Presence of lipid plaque with Max LCBI4mm over 100 assessed by NIRS-IVUS
Key exclusion criteria
(1) patients who are pregnant or breastfeeding
(2) patients for whom evolocumab therapy is contraindicated
(3) patients scheduled to undergo low-density lipoprotein (LDL) apheresis
(4) patients with severe liver dysfunction (such as Child-Pugh classification C)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Sato |
Organization
University of Fukui
Division name
Division of Cardiovascular Medicine, Faculty of Medical Sciences
Zip code
910-1193
Address
23-3 Shimoaizuki Matsuoka, Eiheijicho, Fukui
TEL
0776613111
toppy1363@gmail.com
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Shimizu |
Organization
University of Fukui
Division name
Division of Cardiovascular Medicine, Faculty of Medical Sciences
Zip code
910-1193
Address
23-3 Shimoaizuki Matsuoka, Eiheijicho, Fukui
TEL
0776613111
Homepage URL
s-tomo@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Division of Cardiovascular Medicine, Faculty of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
University of Fukui
Division of Cardiovascular Medicine, Faculty of Medical Sciences
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
Ethics committee of University of Fukui
Address
23-3 Shimoaizuki Matsuoka, Eiheijicho, Fukui
Tel
0776613111
topi@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
| 2022 | Year | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 09 | Month | 23 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 08 | 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
| 2022 | Year | 10 | Month | 16 | Day |
Last modified on
| 2022 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055755
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/04/18 | Resolve_PAD_plan_20220812_revised.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
