UMIN-CTR Clinical Trial

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
Email	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
Email	thorikoshi@yamanashi.ac.jp

Sponsor
Institute	University of Yamanashi, Department of Internal Medicine II
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050854