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UMIN-CTR Clinical Trial |
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Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000012069 |
Receipt No. | R000014051 |
Scientific Title | Randomized trial for Evaluation in Secondary Prevention Efficacy of Combination Therapy - Statin and Eicosapentaenoic Acid |
Date of disclosure of the study information | 2013/10/21 |
Last modified on | 2022/05/11 |
Basic information | ||
Public title | Randomized trial for Evaluation in Secondary Prevention Efficacy of Combination Therapy - Statin and Eicosapentaenoic Acid | |
Acronym | RESPECT-EPA | |
Scientific Title | Randomized trial for Evaluation in Secondary Prevention Efficacy of Combination Therapy - Statin and Eicosapentaenoic Acid | |
Scientific Title:Acronym | RESPECT-EPA | |
Region |
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Condition | ||
Condition | Coronary artery disease | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | Patients with chronic coronary artery disease receiving LDL-C lowering treatment by statin will be randomized to either a control group (standard treatment) or EPA group (standard treatment plus eicosapentaenoic acid), to examine the effects of eicosapentaenoic acid on the incidence of cardiovascular events. Relationship between EPA/AA ratio and incidence of event will be also examined. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Phase IV |
Assessment | |
Primary outcomes | Primary endpoints are the first occurrence of any of the following cardiovascular events.
Cardiovascular death, non-fatal myocardial infarction (MI)*, non-fatal cerebral infarction, unstable angina requiring emergent hospitalization and coronary revascularization, and coronary revascularization based on clinical findings. * indicates not including percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) related MI. |
Key secondary outcomes | (1) Composite endpoint.
1) Composite event of coronary artery disease Endpoints are the first occurrence of any of the following events. Cardiac sudden death, fatal/non-fatal MI*, unstable angina requiring emergent hospitalization and coronary revascularization, and coronary revascularization based on clinical findings. 2) Composite event of cerebrovascular disorders Endpoints are the first occurrence of any of the following events. 2-1) Fatal/non-fatal stroke, hospitalization due to transient ischemic attack. 2-2) Fatal/non-fatal stroke (2) Event relating to death Occurrence of each following event; 1) All-cause death 2) Cardiovascular death 3) Cardiac death (3) 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 (4) 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 (5) 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 (6) Biomarkers |
In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field. |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | YES |
Dynamic allocation | NO |
Institution consideration | Institution is considered as a block. |
Blocking | YES |
Concealment | Central registration |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Continuous administration of statin + EPA 1800mg/day | |
Interventions/Control_2 | Continuous administration of 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 |
In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required. |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Patients with CAD who took statin over one month and met all following criteria;
(1) Patients aged 20 years to 79 years at the time of informed consent (2) Patients given written informed consent CAD 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 |
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Key exclusion criteria | 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 (LVEF<30% or 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 |
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Target sample size | 3900 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Juntendo University Graduate School of Medicine | ||||||
Division name | Department of Cardiology | ||||||
Zip code | |||||||
Address | 2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan | ||||||
TEL | 03-3813-3111 | ||||||
daida@juntendo.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Research Institute for Production Development | ||||||
Division name | Secretariat of RESPECT-EPA | ||||||
Zip code | |||||||
Address | 15, Shimogamo Morimoto-cho, Sakyo-ku, Kyoto, 606-0805 | ||||||
TEL | 075-781-1107 | ||||||
Homepage URL | |||||||
jimu-epa@world.odn.ne.jp |
Sponsor | |
Institute | Study group on treatment of coronary artery disease |
Institute | |
Department |
Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one. |
Funding Source | |
Organization | Japan Heart Foundation |
Organization | |
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Category of Funding Organization | Non profit foundation |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
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Study ID_2 | |
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IND to MHLW |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Recruitment status | No longer recruiting | ||||||
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Management information | |||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014051 |