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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000012069
Receipt No. R000014051
Official scientific title of the study 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 2016/10/19

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Basic information
Official scientific title of the study Randomized trial for Evaluation in Secondary Prevention Efficacy of Combination Therapy - Statin and Eicosapentaenoic Acid
Title of the study (Brief title) RESPECT-EPA
Region
Japan

Condition
Condition Coronary artery disease
Classification by specialty
Cardiology
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
Medicine
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
20 years-old <=
Age-upper limit
80 years-old >
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
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
Target sample size 3900

Research contact person
Name of lead principal investigator Hiroyuki Daida
Organization Juntendo University Graduate School of Medicine
Division name Department of Cardiology
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3813-3111
Email daida@juntendo.ac.jp

Public contact
Name of contact person Kumiko Kitagawa
Organization Research Institute for Production Development
Division name Secretariat of RESPECT-EPA
Address 15, Shimogamo Morimoto-cho, Sakyo-ku, Kyoto, 606-0805
TEL 075-781-1107
Homepage URL
Email 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
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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

Other administrative information
Date of disclosure of the study information
2013 Year 10 Month 21 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2013 Year 09 Month 20 Day
Anticipated trial start date
2013 Year 11 Month 01 Day
Last follow-up date
2021 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2013 Year 10 Month 18 Day
Last modified on
2016 Year 10 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014051


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