RECRUITINGINTERVENTIONAL

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

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form - FFR-CT value ≥0.75, indicating the absence of hemodynamically significant stenosis Who Should NOT Join This Trial: - 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 implantation or coronary artery bypass grafting - history of myocardial infarction - ≥70% luminal stenosis in the proximal left anterior descending artery (LAD), or ≥50% stenosis in the left main (LM) coronary artery - FFR-CT value \<0.75 in any coronary artery - elevated serum alanine aminotransferase (ALT) levels (\>3× the upper limit of normal) - elevated serum creatine kinase (CK) levels (\>3× the upper limit of normal) - LDL cholesterol level \>5 mmol/L - renal failure or significantly impaired renal function (eGFR \<30 mL/min/1.73 m²) - ongoing oncological treatment - active liver disease - known hypersensitivity to any excipients of the investigational product - concomitant treatment with the combination of sofosbuvir/velpatasvir/voxilaprevir - concomitant treatment with cyclosporine - women of childbearing potential not using adequate contraception - presence of myopathy Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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 implantation or coronary artery bypass grafting * history of myocardial infarction * ≥70% luminal stenosis in the proximal left anterior descending artery (LAD), or ≥50% stenosis in the left main (LM) coronary artery * FFR-CT value \<0.75 in any coronary artery * elevated serum alanine aminotransferase (ALT) levels (\>3× the upper limit of normal) * elevated serum creatine kinase (CK) levels (\>3× the upper limit of normal) * LDL cholesterol level \>5 mmol/L * renal failure or significantly impaired renal function (eGFR \<30 mL/min/1.73 m²) * ongoing oncological treatment * active liver disease * known hypersensitivity to any excipients of the investigational product * concomitant treatment with the combination of sofosbuvir/velpatasvir/voxilaprevir * concomitant treatment with cyclosporine * women of childbearing potential not using adequate contraception * presence of myopathy

Treatments Being Tested

DRUG

Rosuvastatin 40mg

Participants 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.

DRUG

Placebo

Participants will receive a placebo for rosuvastatin once a day for 3 months. After the 3-month visit, standard rosuvastatin will be initiated.

DIAGNOSTIC_TEST

Coronary Computed Tomography Angiography (Coronary CTA)

Computed Tomography Angiography including coronary calcium scoring and coronary computed tomography angiography at baseline, 3-month, and 24-month visits with a PCD-CT scanner.

DIAGNOSTIC_TEST