UMIN-CTR Clinical Trial

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

LDL-Cholesterolemia in Stable Coronary Artery Disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

National Hospital Organization

Institute

Department

Personal name

Organization

National Hospital Organization

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

JAPAN

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

01

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2011

Year

01

Month

24

Day

Last modified on

2011

Year

01

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005752