Unique ID issued by UMIN | UMIN000041322 |
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Receipt number | R000047173 |
Scientific Title | Program of vascular evaluation under uric acid control by xanthine oxidase inhibitor, febuxostat: multicenter, randomized controlled study (PRIZE) sub study |
Date of disclosure of the study information | 2020/08/10 |
Last modified on | 2022/08/25 11:56:28 |
Program of vascular evaluation under uric acid control by xanthine oxidase inhibitor, febuxostat: multicenter, randomized controlled study (PRIZE) sub study
Program of vascular evaluation under uric acid control by xanthine oxidase inhibitor, febuxostat: multicenter, randomized controlled study (PRIZE) sub study
Program of vascular evaluation under uric acid control by xanthine oxidase inhibitor, febuxostat: multicenter, randomized controlled study (PRIZE) sub study
Program of vascular evaluation under uric acid control by xanthine oxidase inhibitor, febuxostat: multicenter, randomized controlled study (PRIZE) sub study
Japan |
The analysis data set of the main trial will be used as the database of this study.
Cardiology |
Others
NO
To examine in greater detail the protective effect of febuxostat against vascular damage by patient background and pathology, and to elucidate from various perspectives the efficacy and safety of febuxostat when used for the treatment of hyperuricemia through examination of organ-related effects of febuxostat and the relationship with other clinical indicators obtained in this study, by conducting the sub-studies (as described below) of the program of vascular evaluation under uric acid control by xanthine oxidase inhibitor, febuxostat: multicenter, randomized controlled study (hereinafter referred to as main trial), which was conducted from January 2014 through March 2019.
Specifically, in the sub-studies, the impact of febuxostat on flow-mediated dilation (FMD), pulse wave velocity (PWV), the cardio ankle vascular index (CAVI), IMT, echocardiography, etc., as well as the relationship between febuxostat and other clinical indicators (uric acid level, etc.) will be evaluated. In addition, the impact of febuxostat on exploratory biomarkers, etc., associated with the remodeling of cardiac and renal disorders and the progression of dysfunction, the efficacy and safety of febuxostat in patients with chronic kidney disease (CKD), and the impact of fluctuations in blood pressure on the progression of arteriosclerosis will be examined. Moreover, a more detailed stratified analysis will be conducted by clinical setting and administered dose of febuxostat, and by using such indicators as the uric acid level. By doing these, the efficacy and safety of febuxostat regarding various clinical indicators such as carotid IMT and uric acid level-that have not been analyzed in detail yet although data on these have already been obtained at the main trial-will be analyzed, with the goal of elucidating the effect of febuxostat on hyperuricemia from various perspectives.
Others
Examination of the impact of febuxostat on FMD,carotid plaque echolucency,
IMT,cardiac function,hepatic function, MDA-LDL ,kidneys,biomarkers, and lipids.
Examination for the elucidation of carotid IMT progression factors.Examination of the impact of fluctuations in blood pressure on the progression of arteriosclerosis.Examination of the impact of febuxostat on vascular functions hardness of arteries based on blood-pressure levels and the presence or absence of hypertension and renal impairment.Examination of the impact of febuxostat on carotid IMT based on vascular functions.Examination of the relationship between uric acid and vascular function/ sRAGE.Examination of the impact on carotid IMT by febuxostat dose.Examination of the impact on carotid IMT by uric acid level.Examination of predictive factors of MACE.Examination of the quality of trial data obtained in multicenter studies.
Not applicable
Rate of change from baseline after 24 months in the mean IMT value of the common carotid artery determined by carotid artery ultrasound
1. IMT, FMD, PWV, CAVI, EF, LVEF, E, A, TRPG, e' and E/e' by treatment group at each measurement point
2. Blood test values (red blood cells, white blood cells, hemoglobin, hematocrit, blood platelet count, AST, ALT, LDH, BUN, Na, K, Cl, blood glucose, serum uric acid level, serum lipids: TC, HDL-C, TG, non-HDL-C, LDL-C, serum creatinine, eGFR), serum biomarker values NT-proBNP, high-sensitivity CRP, 1, 5AG, small dense LDL, RLP-C, MDA-LDL, serum cystatin C, RAGE, high-molecular adiponectin, high-sensitivity troponin I, ANGPTL2, Alb, Ca, FGF23, P), and urine test values (urinary albumin excretion, urinary L-FABP) by treatment group at each measurement point
Others,meta-analysis etc
Not applicable |
Not applicable |
Male and Female
The analysis data set of the main trial will be used as the database of this study.
Number of cases in the database:
Febuxostat group: 239 cases
Control group: 244 cases
Not applicable
483
1st name | Koichi |
Middle name | |
Last name | Node |
Saga University
Department of Cardiovascular Medicine
849-8501
5-1-1 Nabeshima, Saga
0952-34-2364
cardiostudy@ml.cc.saga-u.ac.jp
1st name | Atsushi |
Middle name | |
Last name | Tanaka |
Saga University
Department of Cardiovascular Medicine
849-8501
5-1-1 Nabeshima, Saga
0952-34-2364
cardiostudy@ml.cc.saga-u.ac.jp
Department of Cardiovascular Medicine, Saga University
TEIJIN PHARMA LIMITED
Profit organization
Clinical Research Center,Saga University Hospital
5-1-1 Nabeshima, Saga
0952-34-3400
kenkyu-shinsei@ml.cc.saga-u.ac.jp
NO
佐賀大学
2020 | Year | 08 | Month | 10 | Day |
Published
483
Completed
2020 | Year | 05 | Month | 26 | Day |
2020 | Year | 07 | Month | 22 | Day |
2020 | Year | 08 | Month | 04 | Day |
2021 | Year | 12 | Month | 31 | Day |
The analysis data set that was obtained in the main trial will be used as the database of this study.
Program of vascular evaluation under uric acid control by xanthine oxidase inhibitor , febuxostat : multicenter , randomized controlled study
2020 | Year | 08 | Month | 05 | Day |
2022 | Year | 08 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047173
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