Status:
COMPLETED
Rosuvastatin Effect on Atherosclerotic Plaque Metabolism
Lead Sponsor:
University of Coimbra
Collaborating Sponsors:
AstraZeneca
Conditions:
Cardiovascular Diseases
Atherosclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Detailed Description
Background: Cardiovascular diseases (CVD) are the main cause of mortality in developed countries; its prevention is challenging. Advances in molecular imaging of the atherosclerotic plaque enhanced t...
Eligibility Criteria
Inclusion
- Older than 40 years;
- Written informed consent;
- 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
- 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;
Key Trial Info
Start Date :
July 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03233243
Start Date
July 27 2020
End Date
October 27 2022
Last Update
October 28 2022
Active Locations (1)
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1
Centro Hospitalar e Universitário de Coimbra
Coimbra, Portugal, 3000-075