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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002742
Receipt No. R000003334
Scientific Title Proper Level of Lipid Lowering with Pitavastatin and Ezetimibe in Acute Coronary Syndrome
Date of disclosure of the study information 2013/06/30
Last modified on 2016/11/16

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Basic information
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
Condition Acute coronary syndrome
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information YES

Objectives
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

Assessment
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.)

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Department of Cardiology, Tokyo Women's Medical University
Institute
Department

Funding Source
Organization Japan Reserch Promotion Society for Cardiovascular Diseases
Organization
Division
Category of Funding Organization Non profit foundation
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 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)

Other administrative information
Date of disclosure of the study information
2013 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results Published

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 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
Other related information

Management information
Registered date
2009 Year 11 Month 10 Day
Last modified on
2016 Year 11 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003334

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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