UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014067
Receipt number R000016377
Scientific Title Prospective, randomized, open-label, clinical pilot trial comparing the effects of ethyl icosapentate/docosahexaenoate combination on coronary artery lesion and MACCE.
Date of disclosure of the study information 2014/05/26
Last modified on 2022/12/06 18:03:46

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Basic information

Public title

Prospective, randomized, open-label, clinical pilot trial comparing the effects of ethyl icosapentate/docosahexaenoate combination on coronary artery lesion and MACCE.

Acronym

Prospective, randomized, open-label, clinical pilot trial comparing the effects of ethyl icosapentate/docosahexaenoate combination on coronary lesion and MACCE.

Scientific Title

Prospective, randomized, open-label, clinical pilot trial comparing the effects of ethyl icosapentate/docosahexaenoate combination on coronary artery lesion and MACCE.

Scientific Title:Acronym

Prospective, randomized, open-label, clinical pilot trial comparing the effects of ethyl icosapentate/docosahexaenoate combination on coronary lesion and MACCE.

Region

Japan


Condition

Condition

Patients underwent PCI who has history of ischemic stroke

Classification by specialty

Cardiology Endocrinology and Metabolism Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigating effect of ethyl icosapentate/docosahexaenoate combination on coronary lesion, MACCE, progression of atherosclerotic plaques, endothelial function, markers for anti-inflammatory properties/obesity/antioxidative properties

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

(1). MACCE(death from coronary artery disease, nonfatal AMI, AP, revasculization)
(2). Charasteristics of coronary lesion(number of lesion, calcification, bifurcated lesion and SYNTAX score)

Key secondary outcomes

(1) Cerebrovascular events(recurrence of ischemic stroke, hemorrhagic stroke)
(2) Serum Lipids
(3) HDL Function(Cholesterol efflux, anti-inflammatory properties, endothelial function)
(4) Markers of cognitive function(MMSE)
(5) OCT findings(neointimal coverage for stent struts), restenosis/new lesion
(6) Markers of diabetes mellitus(HbA1c, Fasting blood glucose, glycoalbumin)
(7) Markers of obesity(adiponectin)
(8) Inflammatory markers(High-sensitive CRP, MCP-1)
(9) Oxidative-stress markers(MDA-LDL, EC-SOD, 8-OHDG)
(10) Markers of early nephropathy(albumin, creatinine, L-FABP)
(11) Uric acid in blood/urine
(12) Abdominal girth, body height, body weight
(13) Blood pressure, heart rate(home/clinic)
(14) ABI
(15) MCG


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Administration of ethyl icosapentate/docosahexaenoate combination(4g/day)
Duration of administration; 2years(minimum)

Interventions/Control_2

Non-Administration of ethyl icosapentate/docosahexaenoate combination(4g/day)

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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Subjects with fasting serum triglycerides levels>150mg/dL, or HDL-C levels<40/50 mg/dl (male/female) or LDL-C levels>100mg
2) Subjects with ischemic stroke.
3) Subjects with coronary artery disease candidate for PCI
4) Outpatients
5) Subjects who gave written informed consent

Key exclusion criteria

1) Allergy against ethyl icosapentate/docosahexaenoate
2) Poor controlled diabetes mellitus (HbA1c>10%)
3) History of acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months(stroke is excluded)
4) Either level of aspartate aminotransaminase or alanine aminotransferase exceeds three-fold of the normal limits.
5) eGFR 30 mL/min/1.73 m2 or less (in case of the subjects treated statins, eGFR 60 mL/min/1.73 m2 or less)
1) Allergy against ethyl icosapentate/docosahexaenoate
2) Poor controlled diabetes mellitus (HbA1c>10%)
3) History of acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months(stroke is excluded)
4) Either level of aspartate aminotransaminase or alanine aminotransferase exceeds three-fold of the normal limits.
5) eGFR 30 mL/min/1.73 m2 or less (in case of the subjects treated statins, eGFR 60 mL/min/1.73 m2 or less)
6) Symptomatic (NYHA III or IV) congestive heart failure
7) Malignancies or other diseases with poor prognosis
8) Pregnant
9) Severe infection/trauma
10) Subjects who statins treatment is recommended by Guideline of Japan Atherosclerotic Society 2012.
11) Subjects whose doctor in charge do not agree to join the trial

Target sample size

400


Research contact person

Name of lead principal investigator

1st name Masafumi
Middle name
Last name Morimoto

Organization

Yokohama Shintoshi Neurosurgical Hospital

Division name

Department of Neurosurgery

Zip code

225-0013

Address

433 Eda-chou, Aoba-Ku, Yokohama, JAPAN 225-0013

TEL

045-911-2011

Email

gnsmasafumi@gmail.com


Public contact

Name of contact person

1st name Kei
Middle name
Last name Kawai

Organization

Yokohama Shintoshi Neurosurgical Hospital

Division name

Department of Cardiology

Zip code

225-0013

Address

433 Eda-chou, Aoba-Ku, Yokohama, JAPAN 225-0013

TEL

045-911-2011

Homepage URL


Email

k_topia@yahoo.co.jp


Sponsor or person

Institute

Yokohama Shintoshi Neurosurgical Hospital

Institute

Department

Personal name



Funding Source

Organization

Foundation for Promotion of Defense Medicine

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

National Defence Medical College

Address

3-2, Namiki, Tokorozawa-shi, Saitama

Tel

04-2995-1211

Email

honrinri@ndmc.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

2014 Year 05 Month 26 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

Suspended

Date of protocol fixation

2014 Year 02 Month 25 Day

Date of IRB

2014 Year 02 Month 25 Day

Anticipated trial start date

2014 Year 05 Month 26 Day

Last follow-up date

2022 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 05 Month 26 Day

Last modified on

2022 Year 12 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016377


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name