UMIN-CTR Clinical Trial

Public title

Proper Level of Lipid Lowering with Pitavastatin and Ezetimibe in Acute Coronary Syndrome

Acronym

HIJ-PROPER
(The Heart Institute of Japan
PRoper level of lipid lOwering with Pitavastatin and Ezetimibe in acute coRonary syndrome)

Scientific Title

Proper Level of Lipid Lowering with Pitavastatin and Ezetimibe in Acute Coronary Syndrome

Scientific Title:Acronym

HIJ-PROPER
(The Heart Institute of Japan
PRoper level of lipid lOwering with Pitavastatin and Ezetimibe in acute coRonary syndrome)

Region

Japan

Condition

Acute coronary syndrome

Classification by specialty

Medicine in general

Cardiology

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

This study will be conducted in ACS patients who are randomized to receive standard treatment by statin monotherapy or intensive treatment by combination therapy with statin and ezetimibe, to determine the appropriateness of a target LDL-C level of <70 mg/dL in Japanese high-risk patients in secondary prevention by comparing the long-term prognosis for both groups.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

The primary endpoint is the occurrence of any of the following composite cardiovascular events.
1) All-cause death
2) Non-fatal myocardial infarction
3) Non-fatal stroke
4) Onset of unstable angina
5) Revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG])

Key secondary outcomes

1) Cardiovascular events
Non-fatal myocardial infarction, non-fatal stroke, onset of unstable angina, revascularization (PCI/CABG), arrhythmia (new onset of ventricular fibrillation, sustained ventricular tachycardia, or atrial fibrillation)
2) Death
All-cause death, cardiovascular death (sudden cardiac death, fatal myocardial infarction, or fatal stroke)
Sudden cardiac death excluding stroke death
Fatal myocardial infarction
Fatal stroke
3) Heart failure
4) Blood markers
Lipid metabolism, glucose metabolism, adiponectin, hsCRP
5)Extent of progression of coronary lesions (quantitative and qualitative assessments by IVUS, CAG, etc.)
6) Adverse events (and new occurrence of malignant tumor, etc.)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Pitavastatin 2mg will be administered for 3 months after ACS, then adjust the dose of pitavastatin to 1~4mg/day aiming to LDL-C level between 90 and 100mg/dl.

Interventions/Control_2

Pitavastatin 2mg/day and ezetimibe 10mg/day will be administered for 3 months after ACS, then adjust the dose of pitavastatin to 1~4mg/day aiming to LDL-C level under 70mg/dl.

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

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with acute coronary syndrome who meet the following criteria and have provided informed consent for this study.
1) Patients with acute coronary syndrome (either acute myocardial infarction or unstable angina) who underwent coronary angiography (CAG).
Acute coronary syndrome that developed within 10 days before admission and falls under at least one of the following categories:
[1] Ischemic electrocardiogram changes
[2] CK >= 2-fold the institutional ULN; CK-MB or troponin (T or I) exceeding the institutional ULN; or a positive troponin T result on a simple qualitative test
[3] Medical history or physical findings that suggest acute coronary syndrome and evidence of coronary vasospasm or significant coronary stenosis
2) Age: >= 20 years (male or female)
3) LDL-C >= 100 mg/dL
To be calculated using the Friedewald formula (LDL-C = total cholesterol - HDL-C - triglycerides/5).

Key exclusion criteria

1) Known hypersensitivity to the study drugs
2) Triglycerides >= 400 mg/dL
3) Concurrent serious liver disease* or renal disease**
*: Apparent hepatic disorder with AST or ALT >3-fold the institutional ULN
**: Treatment with dialysis or serum creatinine level >3.0 mg/dL
4) Diagnosis of malignant tumor
5) Pregnant or lactating women or women who may be pregnant
6) Familial hypercholesterolemia
7) Percutaneous coronary intervention (PCI) within the past 6 months or coronary artery bypass grafting (CABG) within the past 2 months
8) Current treatment with cyclosporine
9) Other conditions that, in the opinion of the investigator, would render the patient unsuitable for the study

Target sample size

3000

Name of lead principal investigator

1st name
Middle name
Last name	Nobuhisa Hagiwara

Organization

Tokyo Women's Medical University

Division name

Cardiology

Zip code

Address

8-1 Kawada-cho, Shinjuku-ku, Tokyo

TEL

03-3353-8112

Email

hijc-kenkyukai@umin.ac.jp.com

Name of contact person

1st name
Middle name
Last name	Erisa Watanabe

Organization

Tokyo Women's Medical University

Division name

Cardiology

Zip code

Address

8-1 Kawada-cho, Shinjuku-ku, Tokyo

TEL

03-3353-8112

Homepage URL

Email

hijc-kenkyukai@umin.ac.jp

Institute

Department of Cardiology, Tokyo Women's Medical University

Institute

Department

Personal name

Organization

Japan Reserch Promotion Society for Cardiovascular Diseases

Organization

Division

Category of Funding Organization

Non profit foundation

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

仙台循環器病センター(宮城県)
済生会栗橋病院(埼玉県)
新松戸中央総合病院(千葉県)
東京女子医科大学附属八千代医療センター(千葉県)
東京女子医科大学附属青山病院(東京都)
榊原記念病院(東京都)
都立多摩総合医療センター(東京都)
至誠会第二病院(東京都)
多摩北部医療センター(東京都)
都立荏原病院(東京都)
立正佼成会附属佼成病院(東京都)
NTT東日本関東病院(東京都)
荻窪病院(東京都)
西新井病院(東京都)
国立病院機構横浜医療センター(神奈川県)
社会保険相模野病院(神奈川県)
聖隷浜松病院(静岡県)
済生会熊本病院(熊本県)
東京女子医科大学(東京都)
東京女子医科大学東医療センター(東京都）

Date of disclosure of the study information

2013

Year

06

Month

30

Day

URL releasing protocol

Publication of results

Published

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

Completed

Date of protocol fixation

2009

Year

10

Month

23

Day

Date of IRB

Anticipated trial start date

2010

Year

01

Month

01

Day

Last follow-up date

2016

Year

03

Month

31

Day

Date of closure to data entry

2016

Year

04

Month

30

Day

Date trial data considered complete

2016

Year

06

Month

30

Day

Date analysis concluded

2016

Year

07

Month

31

Day

Other related information

Registered date

2009

Year

11

Month

10

Day

Last modified on

2016

Year

11

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003334