Unique ID issued by UMIN | UMIN000011371 |
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Receipt number | R000013050 |
Scientific Title | Research on the efficacy of LOTRIGA on coronary plaque formation and inflammatory cytokine in patients undergoing percutaneous coronary intervention |
Date of disclosure of the study information | 2013/08/06 |
Last modified on | 2013/08/03 20:51:54 |
Research on the efficacy of LOTRIGA on coronary plaque formation and inflammatory cytokine in patients undergoing percutaneous coronary intervention
The efficacy of LOTRIGA on coronary plaque formation and inflammatory cytokine
Research on the efficacy of LOTRIGA on coronary plaque formation and inflammatory cytokine in patients undergoing percutaneous coronary intervention
The efficacy of LOTRIGA on coronary plaque formation and inflammatory cytokine
Japan |
Patients undergoing percutaneous coronary intervention, complicated with dyslipidemia and who are treated with statins under at least six months or more
Cardiology |
Others
NO
This study compares the effect on coronary plaque and inflammatory cytokine of statin therapy to that of statin combined with LOTRIGA in patients undergoing percutaneous coronary intervention
Safety,Efficacy
Evaluation of changes in plaque formation before and after medication by integrated backscatter intravascular ultrasound (IB-IVUS)
Changes in blood inflammation markers
Interventional
Parallel
Randomized
Open -but assessor(s) are blinded
Active
2
Treatment
Medicine |
Continuing statin
Combined application of LOTRIGA 4g a day
20 | years-old | <= |
85 | years-old | > |
Male and Female
1)Patients in which stenosis is found to exceed 75% in 1-2 vessels, prompting implantation of a stent by percutaneous coronary intervention (PCI)
2)Age of patients is 20 years or older and less than 85 years
3)Patients of LDL cholesterol of 100 or less mg/dl, and who are treated with statin (under at least six months or more)
4)Patients who is possible to follow up for 6-8 months after PCI
5)Sex does not ask
6)Patients without the administration schedule of the supplement containing n-3 polyunsaturated fatty acid during exam time
7)Patients who have given written informed consent
1)Patients with a past history of hypersensitivity to LOTRIGA
2)Patients suffering a stroke within the previous 6 months
3)Patients with a left vetricular ejection fraction of 40% or less
4)Patients on dialysis
5)Patients with bleeding (hemophilia, capilary fragility, gastrointestinal bleeding, urinary tract bleeding, hemoptysis, vitreous hemorrhaging etc.)
6)Patients with peptic ulcers
7)Patients considered unsuitable for other reasons
40
1st name | |
Middle name | |
Last name | Masataka Sata |
The Institute of Health Bio-Sciences,The University of Tokushima Graduate School
Department of cardiovascular medicine
3-18-15, Kuramoto-cho
1st name | |
Middle name | |
Last name | Koji Yamaguchi |
Tokushima university hospital
Department of cardiovascular
2-50-1, Kuramoto-cho
Department of cardiovascular medicine,The Institute of Health Bio-Sciences,The University of Tokushima Graduate School
None
Self funding
NO
2013 | Year | 08 | Month | 06 | Day |
Unpublished
Preinitiation
2013 | Year | 05 | Month | 14 | Day |
2013 | Year | 09 | Month | 30 | Day |
2013 | Year | 08 | Month | 05 | Day |
2013 | Year | 08 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013050
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