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

Conditions

Acute coronary syndrome

Tonre Ri, Chihiro Saito, Hiroyuki Arashi, Junichi Yamaguchi, Hiroshi Ogawa et al. (6 authors)

Echocardiography2022-01-183 citations

Baseline low-density lipoprotein cholesterol predicts the benefit of adding ezetimibe on statin in statin-naïve acute coronary syndrome.

Im J, Kawada-Watanabe E, Yamaguchi J, Arashi H, Otsuki H, Matsui Y, Sekiguchi H, Fujii S, Mori F, Ogawa H, Hagiwara N.

2021-04-053 citations

10.1038/s41598-021-87098-x

Targeting high-sensitivity C-reactive protein levels in acute coronary syndrome patients undergoing contemporary lipid-lowering therapy: a sub-analysis of the HIJ-PROPER trial.

Kawada-Watanabe E, Yamaguchi J, Sekiguchi H, Arashi H, Ogawa H, Hagiwara N.

2019-11-056 citations

10.1016/j.jjcc.2019.09.015

Polyunsaturated Fatty Acid Impact on Clinical Outcomes in Acute Coronary Syndrome Patients With Dyslipidemia: Subanalysis of HIJ-PROPER.

Arashi H, Yamaguchi J, Kawada-Watanabe E, Koyanagi R, Sekiguchi H, Mori F, Haruta S, Ishii Y, Murasaki S, Suzuki K, Yamauchi T, Ogawa H, Hagiwara N.

2019-08-084 citations

10.1161/jaha.119.012953

Low-density lipoprotein cholesterol targeting with pitavastatin + ezetimibe for patients with acute coronary syndrome and dyslipidaemia: the HIJ-PROPER study, a prospective, open-label, randomized trial

Nobuhisa Hagiwara, Erisa Kawada‐Watanabe, Ryo Koyanagi, Hiroyuki Arashi, Junichi Yamaguchi et al. (14 authors)

European Heart Journal2017-03-14125 citations

10.1093/eurheartj/ehx162

Rationale, design features, and baseline characteristics: The Heart Institute of Japan-PRoper level of lipid lOwering with Pitavastatin and Ezetimibe in acute coRonary syndrome (HIJ-PROPER).

Kawada-Watanabe E, Ogawa H, Koyanagi R, Arashi H, Yamaguchi J, Matsui K, Hagiwara N.

2016-06-249 citations

10.1016/j.jjcc.2016.05.002

Interventions

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. Pitavastatin 2mg/day and ezetimibe 10mg/

Eligibility

Sex/Gender

All

Inclusion criteria

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).

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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])	—

Secondary

Measure	Time frame
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.)	—

Measure

Time frame

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.)

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Countries

Japan

Contacts

Public ContactErisa Watanabe

Tokyo Women's Medical University Cardiology

hijc-kenkyukai@umin.ac.jp03-3353-8112

Outcome results

None listed