Rosuvastatin effect on atherosclerotic plaque metabolism ¿ a subclinical atherosclerosis imaging study with 18F-NaF PET-CT - ROPPET-NAF

Centro Hospitalar e Universitário de Coimbra, E.P.E.0 个研究点目标入组 44 人开始时间: 2019年11月15日最近更新: 2020年8月3日

适应症

试验速览

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•Hypertensive patients older than 40 years; with written informed consent; AND considered to be at high or very high CV risk according to the European Society of Cardiology guidelines fulfilling any of the following criteria: predicted fatal CV event at 10 years ¿5% (SCORE tables for low-risk countries) OR chronic kidney disease with glomerular filtration rate (GFR) under 60 mL/min (Modification of Diet in Renal Disease equation - MDRD) OR diabetes mellitus (type 1 or 2) OR markedly elevated single risk factors.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 22
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 22

•Previous cardiovascular events; GFR under 30 mL/min; Known hepatic dysfunction or alanine amino-transferase level more than twice the upper limit of the normal (ULN) range; Creatine kinase level more than three times the ULN; Known myopathy; Statin hypersensivity; Hormone replacement therapy; Malignant neoplasms in the past five years (excluding basal-cell skin carcinoma); Uncontrolled hypothyroidism; Chronic inflammatory disease (such as rheumatoid arthritis, inflammatory bowel disease); Pregnancy or women in child bearing age without contraceptive

发起方

Centro Hospitalar e Universitário de Coimbra, E.P.E.