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

Condition(s) targeted: Atherosclerosis; Inflammatory Activity in Coronary Arteries

Intervention: Rosuvastatin (Drug); Placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Björn Fagerberg, MD, Professor, Principal Investigator, Affiliation: Wallenberg LaboratorySahlgrenska University Hospital, S-413 45 Göteborg
Maria Leonsson-Zachrissson, MD, Study Chair, Affiliation: AstraZeneca R&D Mölndal

Overall contact:
AstraZeneca Molndal Clinical Study Information, Phone: + 46 31 776 10 00, Email: maria.eriksson-lepkowska@astrazeneca.com

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.

Official title: 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

Study design: Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment

Primary outcome:

Change in CFR peak velocity within rosuvastatin group after 1 month of treatment compared to baseline

Comparison of treatment effects on CFR peak velocities between groups after 1 month of treatment

Secondary outcome:

Changes in CFR peak velocity within the rosuvastatin group after 3 months compared to baseline and to 1 month

Changes in other CFR parameters after one month rosuvastatin or placebo treatment; comparisons within groups and between groups

Changes in plasma lipids, lipoproteins and other cardiovascular biomarkers after 1 month of treatment with rosuvastatin or placebo; comparisons within groups and between groups

Minimum age: 45 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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

AstraZeneca Molndal Clinical Study Information, Phone: + 46 31 776 10 00, Email: maria.eriksson-lepkowska@astrazeneca.com

Research Site, Goteborg, Sweden; Recruiting

Starting date: October 2008
Ending date: June 2009
Last updated: October 30, 2008