Study of Short-Term High-Dose Rosuvastatin Effects on Coronary Plaque Using Advanced CT Imaging in Statin-Naive Adults with Stable Chest Pain Aged 40-75 Years

What this Trial Is About

Researchers are evaluating the effects of short-term intensified statin therapy on coronary artery plaque characteristics using advanced imaging technology called photon-counting detector CT PCD-CT. This trial focuses on statin-naive patients who have stable chest pain and suspected coronary artery disease. The study aims to understand how intensified statin treatment changes the anatomy and blood flow of coronary arteries and to explore long-term changes in plaque features, testing the plaque memory hypothesis over a 24-month follow-up. Participants are randomly assigned to one of two groups one receives 40 mg of rosuvastatin daily for three months, and the other receives a matching placebo for the same period. After the initial 3-month period, all patients receive rosuvastatin according to standard care. Coronary CT angiography scans and blood tests are performed at baseline, 3 months, and 24 months using a low radiation dose protocol with PCD-CT. The imaging includes detailed analysis of plaque volume, composition, and blood flow dynamics. During the study, patients undergo scheduled coronary CTA scans and blood tests to monitor changes in plaque volume, composition, and coronary blood flow. Researchers use multiple detailed measurements such as fractional flow reserve from CT FFR-CT and radiomic features to assess the impact of treatment. Safety is monitored through laboratory tests including liver and kidney function. The primary outcome is the change in non-calcified plaque volume after 3 months, with additional assessments continuing through 24 months. Participation lasts up to two years with ongoing evaluations.

Changes in Plaque Characteristics After Short-term Statin Therapy as Assessed With Coronary CT