UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044529 |
|---|---|
| Receipt number | R000050854 |
| Scientific Title | Observational prospective study to evaluate clinical significance of statin therapy for secondary prevention in hemodialysis patients |
| Date of disclosure of the study information | 2021/06/20 |
| Last modified on | 2022/04/02 12:14:30 |
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Basic information
Public title
Observational prospective study to evaluate clinical significance of statin therapy for secondary prevention in hemodialysis patients
Acronym
Prospective study of statin therapy in HD patients
Scientific Title
Observational prospective study to evaluate clinical significance of statin therapy for secondary prevention in hemodialysis patients
Scientific Title:Acronym
Prospective study of statin therapy in HD patients
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to investigate the effectiveness of statin therapy for secondary prevention of cardiovascular disease in patients on hemodialysis
Basic objectives2
Others
Basic objectives -Others
Identify clinical factors affecting statin treatment effectiveness for secondary prevention using stratified analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The following outcomes during 3 years after discharge.
1. All cause mortality
2. Non-fatal myocardial infarction
Key secondary outcomes
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
| 18 | years-old | < |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The study patients, who admitted to study facility, met all of the following inclusion criteria;
1. Patients on hemodialysis
Key exclusion criteria
The study patients met any of the following exclusion criteria were excluded:
1. Unsuccessful percutaneous coronary intervention
2. Died within 30 days after percutaneous coronary intervention
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Takeo |
| Middle name | |
| Last name | Horikoshi |
Organization
Yamanashi University Hospital
Division name
Internal Medicine II
Zip code
409-3898
Address
1110 Shimokato, Chuo city, Yamanashi Prefecture
TEL
055-273-9590
thorikoshi@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | Takeo |
| Middle name | |
| Last name | Horikoshi |
Organization
Yamanashi University Hospital
Division name
Internal Medicine II
Zip code
409-3898
Address
1110 Shimokato, Chuo city, Yamanashi Prefecture
TEL
055-273-9590
Homepage URL
thorikoshi@yamanashi.ac.jp
Sponsor or person
Institute
University of Yamanashi, Department of Internal Medicine II
Institute
Department
Personal name
Funding Source
Organization
University of Yamanashi, Department of Internal Medicine II
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
Yamanashi University Hospital
Address
1110 Shimokato, Chuo City, Yamanashi Prefecture
Tel
0552739590
kugiyama@yamanashi.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
市立藤枝総合病院（静岡県）
山梨県立中央病院（山梨県）
市立甲府病院（山梨県）
甲府城南病院（山梨県）
山梨厚生病院（山梨県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
323
Results
MACE occurred in 55 patients. Patients with MACE had significantly lower statin therapy. Multivariable Cox proportional hazards analysis showed that the patients on statins had significantly reduced rate of MACE occurrence.
Results date posted
| 2022 | Year | 04 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 10 | Month | 06 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2007 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2007 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2008 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
All registered patients were prospectively followed up every 6 months in the hospital or with a clinic visit for a period of up to 3 years.
Management information
Registered date
| 2021 | Year | 06 | Month | 14 | Day |
Last modified on
| 2022 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050854
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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