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.
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
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
Prof. Maurovich-Horvat Pál
Lead sponsor
Semmelweis University
Sponsor institution
National Research, Development and Innovation Office, Hungary
Collaborator
HeartFlow, Inc.
Collaborator