Statin effect on atheroma calcificatio

Phase 1

• Conditions: Atherosclerosis, namely in the aorta, carotid and coronary arteries; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2018-003837-13-PT
• Lead Sponsor: Centro Hospitalar e Universitário de Coimbra, E.P.E.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-15
• Last Update Posted: 3 August 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess rosuvastatin effect on atheroma microcalcification process;Secondary Objective: To monitor long-term CV events in the studied individuals; to monitor adverse events with rosuvastatin treatment; to explore the value of 18F-NaF-PET-CT scan in CV risk stratification.;Primary end point(s): 18F-NaF uptake change in vessel wall, calculated by the ratio of the maximum standard uptake value (SUV) in the region of interest and blood pool activity in the superior vena cava, in order to provide tissue-to-background ratio (TBR);Timepoint(s) of evaluation of this end point: 6 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable.