Exploratory Study of Coronary Flow Reserve Measurements, a Non-Invasive Method for Coronary Function Measurements

A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Transthoracic Doppler Echocardiography Method as a Non-Invasive Method for Coronary Function Measurements; Ability to Detect Short-Term Statin Effects in Patients With Increased Cardiovascular Risk

The aim of this study is to investigate whether the non-invasive ultrasound method for assessment of coronary blood flow, transthoracic Doppler echocardiography-coronary flow reserve (TTDE-CFR), can be used to measure drug effects.

Inclusion Criteria:

• Males aged 45-75 years or females aged 60-75 years inclusive
• Carotid and/or femoral atherosclerotic plaque, as assessed by carotid ultrasound examination within the last 5 years
• Abnormal concentrations of lipids or lipoproteins in the blood
• Provision of signed informed consent

Exclusion Criteria:

• Treatment with statins or other lipid-lowering drugs, e.g. fibrates, nicotinic acid, cholesterol absorption inhibitor, within the last 6 months before randomisation
• Current smoking or snuff tobacco use
• Major CV event (myocardial infarction (MI), stroke/ transitory ischemic attack (TIA), Acute Coronary Syndrome (ACS), revascularisation) within the last 6 months before randomisation
• Symptomatic carotid stenosis, atrioventricular (AV) block, QT-prolongation, atrial fibrillation, sinus node disease (such as sick sinus syndrome or symptomatic bradycardia), chronic obstructive pulmonary disease (COPD) or asthma