Statin effect on atheroma calcification

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003837-13-PT

Enrollment

Registered

2019-11-15

Start date

2020-04-20

Completion date

Unknown

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, namely in the aorta, carotid and coronary arteries

Interventions

Trade Name: Crestor Product Name: Rosuvastatin Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ROSUVASTATIN CAS Number: 287714-41-4 Concentration unit: mg milligram(s) Concentration type:

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable.	—

Countries

Portugal

Contacts

Public ContactPrincipal Investigator

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

10642@chuc.min-saude.pt351239400400

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026