Unique ID issued by UMIN | UMIN000012852 |
---|---|
Receipt number | R000015017 |
Scientific Title | Prognostic effects of eicosapentaenoic acid (EPA) in patients with atherosclerotic diseases |
Date of disclosure of the study information | 2014/01/16 |
Last modified on | 2020/01/19 12:31:54 |
Prognostic effects of eicosapentaenoic acid (EPA) in patients with atherosclerotic diseases
Prognostic effects of eicosapentaenoic acid (EPA) in patients with atherosclerotic diseases
Prognostic effects of eicosapentaenoic acid (EPA) in patients with atherosclerotic diseases
Prognostic effects of eicosapentaenoic acid (EPA) in patients with atherosclerotic diseases
Japan |
Patients with atherosclerotic diseases
Cardiology |
Others
NO
Patients with atherosclerotic disease (EPA/AA under 0.4) receiving LDL-C lowering treatment by statin will be randomized to either a control group (standard treatment) or EPA group (standard treatment plus EPA), to examine the effects of EPA on the incidence of cardiovascular events. Relationship between EPA/AA ratio and incidence of event will be also examined.
Safety,Efficacy
Primary endpoints are the first occurrence of any of the following cardiovascular events.
All cause death, cardiovascular death, non-fatal myocardial infarction (MI)*, non-fatal stroke, coronary artery bypass grafting (CABG), and resuscitation from cardiac arrest.
* indicates not including percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) related MI.
(1) Composite endpoint.
1) Composite event of coronary artery disease
Endpoints are the first occurrence of any of the following events.
Unstable angina requiring emergent hospitalization and coronary revascularization, and coronary revascularization based on clinical findings.
2) Event relating to death
Occurrence of each following event;
1) All-cause death
2) Cardiovascular death
3) Cardiac death
(2) Event relating to cardiac disease
Occurrence of each following event;
1) Fatal/non-fatal MI*
2) PCI related MI
3) CABG related MI
4) Stent thrombosis associated with MI
5) Cardiac sudden death
6) Unstable angina requiring emergent hospitalization and coronary revascularization
7) Resuscitation from cardiac arrest
8) Hospitalization due to heart failure
9) New-onset of atrial fibrillation
10) Coronary revascularization (PCI or CABG)
10-1) All coronary revascularization
(a) TLR (b) TVR (c) TVR-Remote (d) Non-TVR
10-2) Coronary revascularization based on clinical findings
(a) TLR (b) TVR (c) TVR-Remote (d) Non-TVR
(3) Events relating to cerebrovascular disorders
Occurrence of each following event;
1) Fatal/non-fatal cerebral hemorrhage
2) Fatal/non-fatal stroke
3) TIA requiring hospitalization
(4) Other events
Occurrence of each following event;
1) Revascularization to peripheral artery disease (PAD)
2) Carotid artery stenting (CAS) or carotid endarterectomy (CEA)
3) Deep vein thrombosis (DVT) or pulmonary thromboembolism (PTE)
4) New occurrence of malignant tumor
5) Progression to dialysis
6) Hemorrhagic event
(5) Biomarkers
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
2
Treatment
Medicine |
Continuous administration of statin + EPA 1800mg/day
Continuous administration of statin
20 | years-old | <= |
100 | years-old | > |
Male and Female
Patients with atherosclerotic diseases who took statin over one month and met all following criteria;
(1) Patients aged 20 years to 99 years at the time of informed consent
(2) Patients given written informed consent
atherosclerotic diseases is defined as having at least one of the following criteria (1) to (3);
(1) History of acute coronary syndrome (acute myocardial infarction or unstable angina)
(2) History of coronary revascularization (PCI or CABG)
(3) Clinically diagnosed ischemic heart disease and severe coronary artery stenosis (75% or higher according to AHA classification) demonstrated in coronary angiography
Patients who meet one of the following criteria;
(1) Patients on dialysis
(2) Patients with serious hepatic disease
(3) Patients with active malignant tumor
(4) Patients for whom coronary angiography or coronary revascularization is scheduled but not yet conducted
(5) Patients with severe heart failure (NYHA class 3 or 4 according to NYHA classification)
(6) Patients who experienced acute coronary syndrome (acute myocardial infarction or unstable angina) within three month at the time of informed consent
(7) Patients who received coronary revascularization (PCI or CABG) within three month at the time of informed consent
(8) Patients with inadequately controlled diabetes mellitus[HbA1c (JDS): 8.0% or more, HbA1c (NGSP): 8.4% or more]
(9) Patients with secondary dyslipidemia associated with (a) nephrotic syndrome, (b) hypothyroidism, (c) Cushing syndrome and (d) other diseases, patients with drug-induced dyslipidemia such as that caused by steroid hormone, or patients receiving EPA (including OTC drugs) or EPA/DHA, or having received such drug within previous 1 month at the time of informed consent
(10) Patients having active bleeding or bleeding tendency
(11) Patients with a history of adverse reaction to EPA
(12) Patients participating in other clinical trial
(13) Pregnant women, possibly pregnant women, or women during lactation
(14) Other patients who, in the opinion of the participating physician, are not eligible
100
1st name | Toshikazu |
Middle name | |
Last name | 7 |
National hospital organization
Minamiwakayama Medical Center
Department of Cardiology
646-8558
27-1, Takainai-cho, Tanabe city, Wakayama, Japan
0739267050
hashidumet98999@yahoo.co.jp
1st name | Toshikazu |
Middle name | |
Last name | Hashizume |
National hospital organization
Department of Cardiology
6468558
27-1, Takainai-cho, Tanabe city, Wakayama, Japan
0739-26-7050
hashidumet98999@yahoo.co.jp
National hospital organization
Minamiwakayama Medical Center
None
Self funding
National hospital organization Minamiwakayama Medical Center
27-1, Takainai-cho, Tanabe city, Wakayama, Japan
0739267050
hashidumet98999@yahoo.co.jp
NO
南和歌山医療センター(和歌山県)
2014 | Year | 01 | Month | 16 | Day |
Unpublished
Preinitiation
2013 | Year | 10 | Month | 30 | Day |
2014 | Year | 01 | Month | 16 | Day |
2014 | Year | 01 | Month | 14 | Day |
2020 | Year | 01 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015017
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