Unique ID issued by UMIN | UMIN000014067 |
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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 |
Prospective, randomized, open-label, clinical pilot trial comparing the effects of ethyl icosapentate/docosahexaenoate combination on coronary artery lesion and MACCE.
Prospective, randomized, open-label, clinical pilot trial comparing the effects of ethyl icosapentate/docosahexaenoate combination on coronary lesion and MACCE.
Prospective, randomized, open-label, clinical pilot trial comparing the effects of ethyl icosapentate/docosahexaenoate combination on coronary artery lesion and MACCE.
Prospective, randomized, open-label, clinical pilot trial comparing the effects of ethyl icosapentate/docosahexaenoate combination on coronary lesion and MACCE.
Japan |
Patients underwent PCI who has history of ischemic stroke
Cardiology | Endocrinology and Metabolism | Adult |
Others
NO
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
Efficacy
(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)
(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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Administration of ethyl icosapentate/docosahexaenoate combination(4g/day)
Duration of administration; 2years(minimum)
Non-Administration of ethyl icosapentate/docosahexaenoate combination(4g/day)
20 | years-old | <= |
90 | years-old | >= |
Male and Female
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
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
400
1st name | Masafumi |
Middle name | |
Last name | Morimoto |
Yokohama Shintoshi Neurosurgical Hospital
Department of Neurosurgery
225-0013
433 Eda-chou, Aoba-Ku, Yokohama, JAPAN 225-0013
045-911-2011
gnsmasafumi@gmail.com
1st name | Kei |
Middle name | |
Last name | Kawai |
Yokohama Shintoshi Neurosurgical Hospital
Department of Cardiology
225-0013
433 Eda-chou, Aoba-Ku, Yokohama, JAPAN 225-0013
045-911-2011
k_topia@yahoo.co.jp
Yokohama Shintoshi Neurosurgical Hospital
Foundation for Promotion of Defense Medicine
Non profit foundation
National Defence Medical College
3-2, Namiki, Tokorozawa-shi, Saitama
04-2995-1211
honrinri@ndmc.ac.jp
NO
2014 | Year | 05 | Month | 26 | Day |
Unpublished
Suspended
2014 | Year | 02 | Month | 25 | Day |
2014 | Year | 02 | Month | 25 | Day |
2014 | Year | 05 | Month | 26 | Day |
2022 | Year | 12 | Month | 31 | Day |
2014 | Year | 05 | Month | 26 | Day |
2022 | Year | 12 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016377
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