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

AstraZeneca

Status and phase: Completed; Early Phase 1

Conditions: Inflammatory Activity in Coronary Arteries; Atherosclerosis

Treatments: Drug: Placebo; Drug: Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00783042

D1840M00006

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

80 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Treatment:

Drug: Rosuvastatin

2

Placebo Comparator group

Treatment:

Drug: Placebo