Rosuvastatin Effect on Atherosclerotic Plaque Metabolism

• Status: Recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Atherosclerotic plaque uptake of 18F-sodium fluoride (NaF) in positron emission tomography with computed tomography (PET-CT) was recently shown to correlate with clinical instability in patients with CV disease. We hypothesize that rosuvastatin reduces 18F-NaF plaque uptake.

Our group will scan coronary, aortic and carotid arteries of high-risk CV subjects with 18F- NaF-PET-CT. Individuals with 18F-NaF-positive plaques will be treated with rosuvastatin for six months, followed by 18F-NaF-PET-CT re-evaluation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Coimbra
• Collaborator: AstraZeneca
• Treatments: Rosuvastatin Calcium

Criteria

Inclusion Criteria:

1. Older than 40 years;

2. Written informed consent;

3. 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);

• chronic kidney disease with glomerular filtration rate (GFR) under 60 mL/min (Modification of Diet in Renal Disease equation - MDRD);

• diabetes mellitus (type 1 or 2);

• markedly elevated single risk factors.

Exclusion Criteria:

• Previous CV 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;