Changes in Plaque Characteristics After Short-term Statin Therapy as Assessed With Coronar
INTENSE Trial is a prospective, double-blind, randomized, placebo-controlled, single-center study with two arms (40 mg intensified statin therapy vs matching placebo for rosuvastatin) among statin-naive patients referred to coronary CT angiography due to stable chest pain, followed for 24 months by using a photon-count
| Condition(s) | Coronary Artery Disease, Atherosclerotic Plaque, Coronary Computed Tomography Angiography, Statin Therapy, Multidetector Computed Tomography, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis, |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | INTENSE Trial is a prospective, double-blind, randomized, placebo-controlled, single-center study with two arms (40 mg intensified statin therapy vs matching placebo for rosuvastatin) among statin-naive patients referred to coronary CT angiography due to stable chest pain, followed for 24 months by using a photon-counting detector CT (PCD-CT). INTENSE Trial aims 1) to assess the effect of short-term intensified statin therapy on coronary anatomy and physiology using PCD-CT and 2) to determine the impact of short-term, intensified statin therapy on coronary plaque morphology and hemodynamics to identify statin responder and non-responder patients in addition to testing the hypothesis of "plaque memory" after the 24-month follow-up period. |
| Who can participate | Inclusion Criteria: * patients referred for coronary computed tomography angiography (CTA) * females aged 45-75 years and males aged 40-75 years * presence of at least mild coronary atherosclerosis (luminal stenosis \>25%, with at least one partially calcified or non-calcified plaque) * statin-naive patients * ability to understand and provide written informed consent * FFR-CT value ≥0.75, indicating the absence of hemodynamically significant stenosis Exclusion Criteria: * contraindications to coronary CTA * current or prior treatment with statins or other lipid-lowering agents (e.g., ezetimibe) * age below 45 years in females or below 40 years in males * age above 75 years in both sexes * pregnancy or breastfeeding * type 1 or type 2 diabetes mellitus * history of coronary stent implantat |
| Ages | 45 Years to 75 Years |
| Sex | All |
| Lead sponsor | Prof. Maurovich-Horvat Pál |
| Locations | Budapest, Budapest, Hungary |
| Start date | 2025-05-28 |
| NCT ID | NCT06603363 |
| Official listing | https://clinicaltrials.gov/study/NCT06603363 |