UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A systematic review and meta-analysis of lipid-lowering therapy using contemporary high-intensity agents for high-risk atherosclerotic patients
Title of the study (Brief title)	A systematic review and meta-analysis of lipid-lowering therapy using contemporary high-intensity agents for high-risk atherosclerotic patients
Region	Japan

Condition
Condition	Patients with atherosclerotic risk
Classification by specialty	Medicine in general Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	What is the most effective/safe high-intensity lipid-lowering therapy for patients with high atherosclerotic risk?
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Major adverse cardiovascular events.
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Randomized controlled trials comparing the more- and less- intensity LLT on clinical outcomes for the patients with atherosclerotic cardiovascular risk.
Key exclusion criteria	Reports with insufficient quality for the data synthesis.
Target sample size	100000

Research contact person
Name of lead principal investigator	Takeshi Kimura
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
Address	54 Shogoinkawaharacho, Sakyo-ku, Kyoto
TEL	81-75-751-4255
Email	totoyota@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Toshiaki Toyota
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
Address	54 Shogoinkawaharacho, Sakyo-ku, Kyoto
TEL	81-75-751-4255
Homepage URL
Email	totoyota@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Kyoto University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 04 Month 30 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 03 Month 14 Day
Anticipated trial start date	2018 Year 03 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Using Medline, The Cochrane Library, ClinicalTrials.gov, and Conference proceedings, eligible RCTs will be extracted for the data synthesis.

Management information
Registered date	2018 Year 03 Month 14 Day
Last modified on	2018 Year 05 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036229