NCT00783042

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Oct 2008

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

June 30, 2009

Status Verified

June 1, 2009

First QC Date

October 30, 2008

Last Update Submit

June 29, 2009

Conditions

AtherosclerosisInflammatory Activity in Coronary Arteries

Keywords

TTDE-CFRcoronary artery functioncardiovascular biomarkersrosuvastatinCrestor

Outcome Measures

Primary Outcomes (2)

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

    Baseline and after 1 month of treatment

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

    Baseline and after 1 month of treatment

Secondary Outcomes (3)

  • 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

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: Rosuvastatin

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

RosuvastatinDRUG

40 mg, tablet, oral, once daily for 1 (double blind) +2 months (open).

Also known as: Crestor
1
PlaceboDRUG

Tablet, oral, once daily for 1 month (double blind)

2

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Atherosclerosis

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Björn Fagerberg, MD, Professor

    Wallenberg LaboratorySahlgrenska University Hospital, S-413 45 Göteborg

    PRINCIPAL INVESTIGATOR

  • Maria Leonsson-Zachrissson, MD

    AstraZeneca R&D Mölndal

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 30, 2008

First Posted

October 31, 2008

Study Start

October 1, 2008

Study Completion

May 1, 2009

Last Updated

June 30, 2009

Record last verified: 2009-06

Locations

SE(1)