UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031724
Receipt number R000036229
Scientific Title A systematic review and meta-analysis of lipid-lowering therapy using contemporary high-intensity agents for high-risk atherosclerotic patients
Date of disclosure of the study information 2018/04/30
Last modified on 2018/05/02 00:36:02

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Basic information

Public title

A systematic review and meta-analysis of lipid-lowering therapy using contemporary high-intensity agents for
high-risk atherosclerotic patients

Acronym

A systematic review and meta-analysis of lipid-lowering therapy using contemporary high-intensity agents for
high-risk atherosclerotic patients

Scientific Title

A systematic review and meta-analysis of lipid-lowering therapy using contemporary high-intensity agents for
high-risk atherosclerotic patients

Scientific Title:Acronym

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

1st name
Middle name
Last name Takeshi Kimura

Organization

Kyoto University Graduate School of Medicine

Division name

Department of Cardiovascular Medicine

Zip code


Address

54 Shogoinkawaharacho, Sakyo-ku, Kyoto

TEL

81-75-751-4255

Email

totoyota@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshiaki Toyota

Organization

Kyoto University Graduate School of Medicine

Division name

Department of Cardiovascular Medicine

Zip code


Address

54 Shogoinkawaharacho, Sakyo-ku, Kyoto

TEL

81-75-751-4255

Homepage URL


Email

totoyota@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University Graduate School of Medicine

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

Preinitiation

Date of protocol fixation

2018 Year 03 Month 14 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036229


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name