Changes in Plaque Characteristics After Short-term Statin Therapy As Assessed with Coronary CT

Launched by PROF. MAUROVICH-HORVAT PÁL · Sep 17, 2024

Keywords

ClinConnect Summary

The INTENSE Trial is a research study that aims to understand how a short-term, stronger dose of statin medication affects the arteries of patients with stable chest pain. Statins are medicines commonly used to lower cholesterol and can help improve heart health. In this study, two groups of patients will be compared: one group will receive a higher strength statin, while the other group will receive a placebo (a pill that looks like the medication but contains no active ingredients). Researchers will use advanced imaging technology called coronary CT angiography to observe changes in the patients' heart arteries and plaque over a period of 24 months.

To be eligible for this trial, participants need to be at least 35 years old if female or 30 years old if male, and must not have taken statins before. They must also have at least one plaque in their arteries that can be partially or fully seen during the imaging. Participants will not be able to join the study if they have certain health conditions, such as diabetes or a history of heart procedures. Throughout the study, participants will undergo imaging tests and regular follow-ups to monitor their heart health and see how their bodies respond to the treatment. This trial is important because it may help doctors identify which patients benefit most from statins and provide better care for heart health in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Clinically indicated coronary CT angiography
• • Min. 35 yo. females or min. 30 yo. males
• • Statin naive patients
• • There are no contraindications to CT angiography
• • Understanding and signing the consent form
• • At least one partially-calcified or non-calcified plaque
• • FFRCT\>0.75 distal to stenosis
• Exclusion Criteria:
• • History of statin treatment
• • \<35 yo. females or \<30 yo. males
• • Diabetes mellitus (Type I. and II.)
• • Coronary artery stent or bypass graft
• • Previous myocardial infarction
• • Elevated alanine aminotransferase levels (\>3x upper limit of normal)
• • Elevated creatine kinase (\>3x upper limit of normal)
• • Elevated low density lipoprotein (\>5 mmol/L)
• • Pregnancy or breastfeeding
• • Chronic renal failure (eGFR \<30 ml/m2)
• • Active oncological treatment
• • ≥70% luminal stenosis in proximal LAD or ≥50% luminal stenosis in left main coronary artery