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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00783042
First received: October 30, 2008
Last updated: June 29, 2009
Last verified: June 2009
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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

Resource links provided by NLM:

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

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
Study Completion Date: May 2009
Arms Assigned Interventions
Active Comparator: 1 Drug: Rosuvastatin
40 mg, tablet, oral, once daily for 1 (double blind) +2 months (open).
Other Name: Crestor
Placebo Comparator: 2 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

Locations
Sweden
Research Site
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

No publications provided

Responsible Party: Björn Carlsson MD, PhD, Medical Science Director, Clinical Discovery Team CV/GI, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00783042     History of Changes
Other Study ID Numbers: D1840M00006
Study First Received: October 30, 2008
Last Updated: June 29, 2009
Health Authority: Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board

Keywords provided by AstraZeneca:
TTDE-CFR
coronary artery function
cardiovascular biomarkers
rosuvastatin
Crestor

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013