UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004938
Receipt No. R000005752
Scientific Title Target Level for LDL-Cholesterol Lowering in Coronary artery disease in Japan
Date of disclosure of the study information 2011/01/24
Last modified on 2011/01/20

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Target Level for LDL-Cholesterol Lowering in Coronary artery disease in Japan
Acronym LDL-TARGET Study
Scientific Title Target Level for LDL-Cholesterol Lowering in Coronary artery disease in Japan
Scientific Title:Acronym LDL-TARGET Study
Region
Japan

Condition
Condition LDL-Cholesterolemia in Stable Coronary Artery Disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effect of regimens designed to produce intensive lipid loweing (LDL-C<70mg/dl) or standard lipid lowering (LDL-C<100mg/dl) on Major Adverse Cardiaovascular and Cerebrovascular Events in Japanese Patients with Stable Coronary Artery Disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Major Adverse Cardiovascular and Cerebrovascular Events (Sudden cardiac death,Lethal or Non-lethal myocardial infarction, Lethal or Non-lethal Stroke,Lethal or Non-lethal Cerebrovascular hemorrhage)
Key secondary outcomes 1) Death, Revascularization(Coronary arteries,Aorta,Peripheral vessels), Heart failure, Unstable angina
2) Lipid Profiles
3) Adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intensive LDL-C Lowering:To achieve the LDL-C level under 70mg/dl, increase the dose of statins or change into a strong statin or combine drugs such as ezetimibe with a statin
Interventions/Control_2 Standard LDL-C Lowering:To achieve the LDL-C level under 100mg/dl,select the dose/ kinds of statins or drugs combined with a statin. If the LDL-C level under 80mg/dl, decrease the dose of statins or of drugs combined with a statin.
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
80 years-old >
Gender Male and Female
Key inclusion criteria Patients with stable coronary artery disease satisfied with the followings;
1) Serum LDL-Cholesterol level over 100mg/dl
2) Coronary stenosis over 75% (AHA clasification) is confirmed by Coronary angiogram or CT/MRI
3) men and women aged 20-80years
4) patients signed their consent form
5) dosen't matter any previous lipid-lowering therpy
Key exclusion criteria 1) Acute coronary syndrome(Unstable angina,patients who had a myocardial infarction within 2 weeks)
2) abnormal liver function(AST/ALT/ALP> 3 times the upper limit of normal)
3) impaired renal function(creatinine>2 times the upper limit of normal)
4) secondary hypercholesterolemia, drug-induced hypercholesterolemia, and familial hypercholesterolemia
5) patients who cannot quit fibrates
6) Uncontrolled hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110mmHg)
7) Uncontrolled diabetes mellitus (HbA1c over 9.5%)
8) women who are pregnant or give the breaset, or women who have a possibility of pregnancy
9) patients judged as ineligible by doctors in charge
Target sample size 3000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Hiyamuta
Organization National Hospital Organization
Kyushu Medical Center
Division name Cardiovascular clinic
Zip code
Address 1-8-1 Jigyouhama, Chuo-ku, Fukuoka city 810-8563, JAPAN
TEL 092-852-0700
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization National Hospital Organization Kyushu Medical Center
Division name Cardiovascular clinic
Zip code
Address 1-8-1 Jigyouhama, Chuo-ku, Fukuoka city 810-8563, JAPAN
TEL
Homepage URL
Email

Sponsor
Institute National Hospital Organization
Institute
Department

Funding Source
Organization National Hospital Organization
Organization
Division
Category of Funding Organization
Nationality of Funding Organization JAPAN

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
2011 Year 01 Month 24 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 Enrolling by invitation
Date of protocol fixation
2010 Year 04 Month 19 Day
Date of IRB
Anticipated trial start date
2010 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 01 Month 24 Day
Last modified on
2011 Year 01 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005752

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.