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
Parallel
Rosuvastatin 40mg
DrugParticipants will receive 40 mg of rosuvastatin once a day for 3 months. After the 3-month visit, the dose will be reduced to a dose per standard of care.
Placebo
DrugParticipants will receive a placebo for rosuvastatin once a day for 3 months. After the 3-month visit, standard rosuvastatin will be initiated.
Coronary Computed Tomography Angiography (Coronary CTA)
Diagnostic testComputed Tomography Angiography including coronary calcium scoring and coronary computed tomography angiography at baseline, 3-month, and 24-month visits with a PCD-CT scanner.
Blood test
Diagnostic testBlood test at baseline, 3-month, and 24-month visits.
Change in non-calcified plaque volume during a 3-month follow-up period.
Expressed as absolute change and as a percentage of baseline.
Change in total plaque volume at 3-month follow-up period.
Expressed as change in total plaque volume (mm3) at 3-month follow-up.
Change in low attenuation non-calcified plaque volume during a 3-month follow-up period.
Expressed as absolute change and as a percentage of baseline.
Change in low attenuation non-calcified plaque volume during a 24-month follow-up period.
Expressed as absolute change and as a percentage of baseline.
Change in total plaque volume during a 24-month follow-up period.
Expressed as absolute change and as a percentage of baseline.
Changes in blood lipid profile
Expressed as change from baseline in total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides, LP(a), apoA1 and apoB levels.
Changes in inflammatory markers
Expressed as change in hs-CRP and ferritin.
Changes in markers of glucose homeostasis
Expressed as change in hemoglobin A1c.
Click on the lead sponsor to view all of their trials.
Prof. Maurovich-Horvat Pál
Lead sponsor
Semmelweis University
Sponsor institution
National Research, Development and Innovation Office, Hungary
Collaborator
HeartFlow, Inc.
Collaborator
