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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00783042

Purpose

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.

Condition	Intervention	Phase
Atherosclerosis Inflammatory Activity in Coronary Arteries	Drug: Rosuvastatin Drug: Placebo	Phase 0

Drug Information available for: Rosuvastatin Rosuvastatin calcium

U.S. FDA Resources

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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Comparison of treatment effects on CFR peak velocities between groups after 1 month of treatment [ Time Frame: Baseline and after 1 month of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in CFR peak velocity within the rosuvastatin group after 3 months compared to baseline and to 1 month [ Time Frame: Bseline, after 1 month and after 3 months of treatment ] [ Designated as safety issue: No ]
Changes in other CFR parameters after one month rosuvastatin or placebo treatment; comparisons within groups and between groups [ Time Frame: Baseline and after 1 month of treatment ] [ Designated as safety issue: No ]
Changes in plasma lipids, lipoproteins and other cardiovascular biomarkers after 1 month of treatment with rosuvastatin or placebo; comparisons within groups and between groups [ Time Frame: Baseline and after 1 month of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	October 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Rosuvastatin 40 mg, tablet, oral, once daily for 1 (double blind) +2 months (open).
2: Placebo Comparator	Drug: Placebo Tablet, oral, once daily for 1 month (double blind)

Eligibility

Ages Eligible for Study:	45 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00783042

Contacts

Contact: AstraZeneca Molndal Clinical Study Information

+ 46 31 776 10 00

maria.eriksson-lepkowska@astrazeneca.com

Locations

Sweden
Research Site	Recruiting
Goteborg, Sweden

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Björn Fagerberg, MD, Professor	Wallenberg LaboratorySahlgrenska University Hospital, S-413 45 Göteborg
Study Chair:	Maria Leonsson-Zachrissson, MD	AstraZeneca R&D Mölndal

More Information

Responsible Party:	AstraZeneca Pharmaceuticals ( Björn Carlsson MD, PhD, Medical Science Director, Clinical Discovery Team CV/GI )
Study ID Numbers:	D1840M00006
Study First Received:	October 30, 2008
Last Updated:	October 30, 2008
ClinicalTrials.gov Identifier:	NCT00783042
Health Authority:	Sweden: Medical Products Agency; Sweden: Regional Ethical Review Board

Keywords provided by AstraZeneca:

TTDE-CFR
coronary artery function
cardiovascular biomarkers
rosuvastatin
Crestor

Study placed in the following topic categories:

Arterial Occlusive Diseases
Atherosclerosis
Rosuvastatin
Vascular Diseases
Arteriosclerosis

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Enzyme Inhibitors

Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009