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

AstraZeneca1 site in 1 country80 target enrollmentOctober 2008

ConditionsAtherosclerosis Inflammatory Activity in Coronary Arteries

InterventionsRosuvastatin Placebo

DrugsRosuvastatin Placebo

Overview

Phase: Early Phase 1
Intervention: Rosuvastatin
Conditions: Atherosclerosis
Sponsor: AstraZeneca
Enrollment: 80
Locations: 1
Primary Endpoint: Change in CFR peak velocity within rosuvastatin group after 1 month of treatment compared to baseline
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 2008

End Date

May 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility 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

Arms & Interventions

1

Intervention: Rosuvastatin

2

Intervention: Placebo

Outcomes

Primary Outcomes

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

Time Frame: Baseline and after 1 month of treatment

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

Time Frame: Baseline and after 1 month of treatment

Secondary Outcomes

Changes in CFR peak velocity within the rosuvastatin group after 3 months compared to baseline and to 1 month(Bseline, after 1 month and after 3 months of treatment)
Changes in other CFR parameters after one month rosuvastatin or placebo treatment; comparisons within groups and between groups(Baseline and after 1 month of treatment)
Changes in plasma lipids, lipoproteins and other cardiovascular biomarkers after 1 month of treatment with rosuvastatin or placebo; comparisons within groups and between groups(Baseline and after 1 month of treatment)