BridgeMD
New treatment option for Coronary Artery Disease
Official title Changes in Plaque Characteristics After Short-term Statin Therapy as Assessed With Coronary CT
ClinicalTrials.gov ID: NCT06603363
What this study is testing
What is Rosuvastatin 40mg?
Rosuvastatin 40mg is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for coronary artery disease.
Also referred to as Intensified Statin Therapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 75
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Budapest, Budapest, Hungary
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Budapest, Budapest, Hungary. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.