UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012069 |
|---|---|
| Receipt number | 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 17:26:58 |
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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
| 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
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
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
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Daida |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Cardiology
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
daida@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Kumiko |
| Middle name | |
| Last name | Kitagawa |
Organization
Research Institute for Production Development
Division name
Secretariat of RESPECT-EPA
Zip code
606-0805
Address
15, Shimogamo Morimoto-cho, Sakyo-ku, Kyoto, 606-0805
TEL
075-781-1107
Homepage URL
jimu-epa@world.odn.ne.jp
Sponsor or person
Institute
Study group on treatment of coronary artery disease
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Juntendo University
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-5802-1589
chiken@juntendo.ac.jp
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 24 | 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
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 09 | Month | 15 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 18 | Day |
Last modified on
| 2022 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014051
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