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Rosuvastatin Effect on Atherosclerotic Plaque Metabolism (ROPPET-NAF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03233243
Recruitment Status : Not yet recruiting
First Posted : July 28, 2017
Last Update Posted : October 15, 2019
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Manuel Oliveira Santos, University of Coimbra

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 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.


Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Atherosclerosis Molecular Imaging Drug: Rosuvastatin Oral Tablet Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Rosuvastatin Effect on Atherosclerotic Plaque Metabolism - a Subclinical Atherosclerosis Imaging Study With 18F-NaF PET-CT
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Arm Intervention/treatment
Experimental: Patients with positive 18F-NaF plaques
Patients with 18F-NaF-positive plaques (coronary, aortic or carotid) with TBR > 1.5
Drug: Rosuvastatin Oral Tablet
Patients with 18F-NaF-positive plaques will be treated with 20 mg of rosuvastatin daily for six months, except in patients who need a 55% LDL reduction to achieve recommended targets (rosuvastatin 40 mg). A second visit (visit 2) will take place eight weeks after therapy initiation to monitor for compliance and adverse events report: therapy will be discontinued if there is an elevation of creatine kinase over five times the ULN with myalgia or alanine amino-transferase three times the ULN.

No Intervention: Patients without 18F-NaF-positive plaques
Subjects without 18F-NaF- positive plaques will be excluded from the pharmacological intervention study



Primary Outcome Measures :
  1. Variation in 18F-NaF uptake in coronary, aortic and carotid plaques (tissue to background ratio - TBR) [ Time Frame: 6 months ]
    • Whole body 18F-NaF-PET-CT for identification of coronary, carotid, thoracic and abdominal aorta arteries plaques:
    • administration of 125 MBq 18F-NaF intravenously, followed by an attenuation correction CT scan and PET imaging after 60 min. Coronary images will be reconstructed according with the usual protocol of PET-CT. Two-dimensional regions of interest will be drawn around all major epicardial coronary vessels and around the major vessels on three millimetres axial slices.
    • Quantification of 18F-NaF uptake at baseline and after optimal treatment including statins:
    • ratio of the maximum standard uptake value (SUV) in the region of interest (the decay corrected tissue concentration of the tracer divided by the injected dose per bodyweight) and blood pool activity in the superior vena cava: tissue-to-background ratio (TBR).
    • Primary outcome: variation in maximum TBR at any vascular territory (coronary, carotid or aortic)


Secondary Outcome Measures :
  1. Variation in 18F-NaF uptake in coronary, aortic and carotid plaques (corrected uptake per lesion - CUL) [ Time Frame: 6 months ]
    • Quantification of 18F-NaF uptake at baseline and after optimal medical treatment
    • difference between the maximum SUV in the region of interest and blood pool activity in the superior vena cava: corrected uptake per lesion - CUL.
    • Primary outcome: variation in maximum CUL at any vascular territory (coronary, carotid or aorta)


Other Outcome Measures:
  1. Safety outcome [ Time Frame: 6 months ]
    Adverse events monitoring related with medical treatment namely statins: myalgia, myopathy (CK), hepatotoxicity (ALT), gastrointestinal symptoms.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03233243


Contacts
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Contact: Manuel Oliveira Santos, MD 00351967925077 oliveirasantos@uc.pt
Contact: Maria João Vidigal Ferreira, PhD 239400400 mjferreira@fmed.uc.pt

Sponsors and Collaborators
University of Coimbra
AstraZeneca
Investigators
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Study Director: Miguel Castelo-Branco, PhD Coimbra's University - Faculty of Medicine

Publications:

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Responsible Party: Manuel Oliveira Santos, MD, University of Coimbra
ClinicalTrials.gov Identifier: NCT03233243    
Other Study ID Numbers: ICNAS-2016-01
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Manuel Oliveira Santos, University of Coimbra:
Rosuvastatin
Sodium fluoride
Positron-emission tomography
Additional relevant MeSH terms:
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Atherosclerosis
Plaque, Atherosclerotic
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathological Conditions, Anatomical
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors