Adults 50 to 99, any sex, with Atherosclerosis or Hypercholesterolemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Mean of Wall Volume of Internal Carotid ArteriesPrimary· 24 months
Wall volume of internal carotid arteries was measured using magnetic resonance imaging. Participants will undergo 2D and 3D carotid MRI using a 3 Tesla scanner and surface carotid coils. Participants with mild or no atherosclerosis, defined as the lowest tertile of wall volume, will have statin therapy adjusted to a target range of 100-130 mg/dL. Participants in the middle tertile will receive statin therapy adjusted to achieve a target LDL 70-100 mg/dL. Participants with the most severe atherosclerosis will receive statin therapy to an LDL target between 40 and 70 mg/dL. Participants in the S
Group
Value
95% CI
Imaging
-3.52
-7.552305 – 0.506032
Standard
-5.91
-10.9683601 – -0.8536061
Adverse events — posted to ClinicalTrials.gov
Time frame: 24 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Imaging
Serious: 18/116 (16%)
Deaths: 0/116
Standard
Serious: 18/114 (16%)
Deaths: 1/114
Serious adverse events (33 terms)
Reaction
System
Imaging
Standard
Hepatic enzyme abnormal
Investigations
—
—
Arthroscopic surgery
Surgical and medical procedures
—
—
Acute myocardial infarction
Cardiac disorders
—
—
Coronary artery disease
Cardiac disorders
—
—
Gastrointestinal haemorrhage
Gastrointestinal disorders
—
—
Pancreatitis
Gastrointestinal disorders
—
—
Death
General disorders
—
—
Cellulitis
Infections and infestations
—
—
Pneumonia
Infections and infestations
—
—
accidental overdose
Injury, poisoning and procedural complications
—
—
Concussion
Injury, poisoning and procedural complications
—
—
Blood creatine abnormal
Investigations
—
—
Haemoglobin abnormal
Investigations
—
—
Hospitalisation
Investigations
—
—
adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Biopsy skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Gingival cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Oral neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Spinal cord herniation
Nervous system disorders
—
—
Amnesia
Psychiatric disorders
—
—
Epiglottitis
Respiratory, thoracic and mediastinal disorders
—
—
Aortic surgery
Surgical and medical procedures
—
—
Breast conserving surgery
Surgical and medical procedures
—
—
Cardiac ablation
Surgical and medical procedures
—
—
Other adverse events (105 terms — click to expand)
Background:
\- Atherosclerosis (thickening of the artery walls caused by cholesterol and other deposits) commonly occurs in the heart vessels and carotid (neck) arteries of adults. This is often present in individuals with high cholesterol levels in their blood. These patients are usually treated with cholesterol lowering medication ( statins ) along with modification of diet and exercise. Researchers are interested in investigating new approaches including magnetic resonance imaging (MRI) and computed tomography (CT) imaging studies to detect blood vessel blockages that would not otherwise be detected by cholesterol levels and risk factors for heart disease.
Objectives:
\- To measure atherosclerosis in the heart vessels and carotid arteries using imaging tests (computed tomography (CT) and magnetic resonance imaging (MRI)) before and after standard treatment with cholesterol lowering medication ( statins )
Eligibility:
\- Healthy individuals at least 55 years of age who are candidates for therapy to lower their blood cholesterol levels.
Design:
* This study will involve one screening visit and seven study visits over a period of 2 years.
* Participants will be screened with a physical examination and medical history, as well as blood samples and tests to ensure that it is safe for them to have CT and MRI scans. Participants will provide information on current medications, dietary habits, smoking status, alcohol and caffeine intake, and their level of physical activity.
* Participants will be divided into two groups. One group will receive standard doses of medication to lower cholesterol according to current treatment guidelines, while the other group will have MRI scans of the carotid arteries and a CT scan of the heart to determine the best medication dose levels.
* Visits 3 to 5 will be scheduled 3, 6, and 9 months after visit 2. During these visits, researchers will monitor for possible side effects and may change or adjust medications and doses.
* At visit 6, participants will have an MRI scan of the carotid arteries, a physical examination, and blood tests. Medications may be changed or adjusted.
* At visit 7, participants will have blood tests, and medications may be changed or adjusted.
* At the final visit, participants will have MRI and CT scans of the carotid arteries and heart, respectively, as well as a final physical examination and blood tests.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07448038 — A Study to Evaluate the Efficacy, Safety, Pharmacodynamics (PD), and Pharmacokinetics (PK) of Selnoflast in Reducing Vas
· Phase 2
· recruiting
NCT06535568 — Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO
· NA
· recruiting
NCT06788431 — A Clinical Study of IMC-001 for Injection in Improving Atherosclerotic Plaque Stability in Patients With Acute Coronary
· EARLY_PHASE1
· recruiting
NCT06676046 — Natural History of Uncommon Dyslipidemias, Rare Lipid Disorders and Unusual Atherosclerotic Conditions
· recruiting
NCT06694012 — Osaka Cardiometabolic Epidemiological Study: Ohtori Study Part 2
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Heart, Lung, and Blood Institute (NHLBI)
Last refreshed: 30 November 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01212900.