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

RecruitingNAAges 45 Years - 75 YearsAllProf. Maurovich-Horvat Pรกl
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ0.75, 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 * โ‰ฅ70% luminal stenosis in the proximal left anterior descending artery (LAD), or โ‰ฅ50% stenosis in the left main (LM) coronary artery * FFR-CT value \<0.75 in any coronary artery * elevated serum alanine aminotransferase (ALT) levels (\>3ร— the upper limit of normal) * elevated serum creatine kinase (CK) levels (\>3ร— the upper limit of normal) * LDL cholesterol level \>5 mmol/L * renal failure or significantly impaired renal function (eGFR \<30 mL/min/1.73 mยฒ) * 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
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What it tests

  • Rosuvastatin 40mg
  • Placebo
  • Coronary Computed Tomography Angiography (Coronary CTA)
  • Blood test
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Where

1 site
Semmelweis University, Medical Imaging Centre
Budapest, Hungary
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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