UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051955 |
|---|---|
| Receipt number | R000059294 |
| Scientific Title | Prospective observational study to investigate lipid-related residual risks for the patients with acute coronary syndrome who were administrated high-dose strong statin |
| Date of disclosure of the study information | 2023/08/20 |
| Last modified on | 2024/03/24 11:03:09 |
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Basic information
Public title
Prospective observational study to investigate lipid-related residual risks for the patients with acute coronary syndrome who were administrated high-dose strong statin
Acronym
Investigation of lipid-related residual risks after acute coronary syndrome
Scientific Title
Prospective observational study to investigate lipid-related residual risks for the patients with acute coronary syndrome who were administrated high-dose strong statin
Scientific Title:Acronym
Investigation of lipid-related residual risks after acute coronary syndrome
Region
| Japan |
Condition
Condition
Acute myocardial infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to reveal incidence and a relative factor of unachievement of guideline-recommended goal of lipid management after Rosuvastatin 10mg/day treatment for Japanese acute myocardial infarction (AMI) patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The patients who fully achieved the guideline-recommended goal of lipid management, were defined as "achieved group". All the rest were defined as "unachieved group". Of them, incidence and relative factor of the unachieved group will be assessed in the present study.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
n-of-1
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
Rosuvastatin 10md/day
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who diagnosed as AMI based on 4th universal definition and underwent percutaneous coronary intervention
Key exclusion criteria
(1) Cases who have a contraindication of rosuvastatin treatment (such as in patients receiving cyclosporine) or requires cautious administration (patients with hypothyroidism or patients planning to use fibrates other than fenofibrate).
(2) Cases who have a side effects like muscle pain and poor tolerability to rosuvastatin oral administration.
(3) Cases who have already used or have a plan to use other high cholesterol-improving medications (such as evolocumab or ezetimibe) during the observation period.
(4) Cases of familial hypercholesterolemia.
(5) Cases with chronic inflammatory diseases (autoimmune diseases) or ongoing cancer treatment.
(6) Cases with impaired consciousness, general malaise, or severe mental disorders.
(7) Other cases who are deemed inappropriate by the investigator.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Ishida |
Organization
Iwate Medical University
Division name
Department of Internal Medicine, Division of Cardiology
Zip code
028-3695
Address
2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate, Japan
TEL
019-613-7111
maishida@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Masaru |
| Middle name | |
| Last name | Ishida |
Organization
Iwate Medical University
Division name
Department of Internal Medicine, Division of Cardiology
Zip code
028-3695
Address
2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate, Japan
TEL
019-613-7111
Homepage URL
maishida@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
None
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
Iwate Medical University
Address
2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate, Japan
Tel
019-613-7111
maishida@iwate-med.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
岩手医科大学、八戸赤十字病院、岩手県立中部病院、岩手県立宮古病院、岩手県立大船渡病院、岩手県立久慈病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 20 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/internalmedicine/advpub/0/advpub_3476-24/_pdf/-char/ja
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/internalmedicine/advpub/0/advpub_3476-24/_pdf/-char/ja
Number of participants that the trial has enrolled
62
Results
Despite the use of high-dose rosuvastatin, 61.7% of the enrolled AMI patients were included in the unachieved group. In addition, the unachieved group had higher sd LDL-C and lipoprotein (a) levels than the achieved group. Logistic regression analyses demonstrated that low baseline high-density lipoprotein cholesterol (HDL-C) levels and the absence of diabetes were predictors of inclusion in the unachieved group.
Results date posted
| 2024 | Year | 03 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This was a single-arm interventional study of AMI pa- tients who underwent rosuvastatin 10 mg monotherapy with- out the concomitant use of other lipid-lowering agents, such as ezetimibe or fibrates. Between April 2021 and December 2021, we enrolled eligible patients with AMI who underwent percutaneous coronary intervention (PCI) at Iwate Medical University Hospital or affiliated hospitals (Iwate Prefectural Chubu Hospital, Hachinohe Red Cross Hospital, Iwate Prefectural Kuji Hospital, Iwate Prefectural Miyako Hospital, and Iwate Prefectural Ofunato Hospital). AMI was diagnosed based on the fourth universal definition of myocardial infarction. Regarding the patients enrolled in this study, PCI was performed under an expert consensus document published by the Japanese Association of Cardiovascular Intervention and Therapeutics. After patients became capable of oral intake, those with AMI received rosuvastatin 10 mg/day, in addition to lifestyle modification therapy, regardless of the baseline LDL-C level. Because this study was exploratory, the target number of cases was set at 60, which was achievable within a limited budget. The exclusion criteria were as follows: (1) patients with homozygous FH in whom the use of other cholesterol-lowering agents (evolocumab or ezetimibe) during the observation period was planned, (2) those who were contraindicated for rosuvastatin treatment or with a poor tolerance to rosuvastatin due to myalgia, (3) those with chronic inflammatory diseases with an estimated glomerular filtration rate (eGFR) <30 mL/min/ 1.73 m2 or ongoing cancer treatment, (4) those with an impaired consciousness or severe mental illness makes obtain- ing consent difficult, and (5) those with difficulty in attending follow-up visits.
Participant flow
All patients underwent blood sampling test at 12-week follow-up.
Adverse events
All clinical adverse events during study period were recorded, while this study did not assess clinical outcomes.
Outcome measures
The primary endpoint of the present study was the prevalence of residual lipid-related risks, defined as the unachievement of "1 of the following JAS guideline- recommended treatment goals at 12 weeks: levels of LDL-C>=70 mg/dL and/or HDL <40 mg/dL and/or TG >=175 mg/dL. The secondary endpoints were the levels of lipid-related surrogate markers at 12 weeks, including small-dense LDL-C (sd LDL-C), lipoprotein (Lp) (a), and high-sensitivity C- reactive protein. SRL Inc. (Tokyo, Japan) measured the sd LDL-C and Lp (a) levels in this study; in contrast, other laboratory data were measured at each hospital.
Plan to share IPD
The deidentified participant data will not be shared.
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 11 | Month | 06 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2024 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2024 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 20 | Day |
Last modified on
| 2024 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059294
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