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Effects of Rosuvastatin on Aortic Stenosis Progression (ASTRONOMER)
This study is currently recruiting participants.
Verified by AstraZeneca, December 2008
Sponsors and Collaborators: AstraZeneca
University of Ottawa Heart Institute
Information provided by: AstraZeneca Identifier: NCT00800800

The purpose of this study is to assess the effects of rosuvastatin compared to usual care in patients diagnosed with aortic valvular stenosis. Patients must have a diagnosis of mild to moderate aortic stenosis (AS) and no clinical indication for the use of cholesterol lowering agents. A multi-centre, randomized, double-blind, placebo-controlled study, with a two year recruitment period, and a treatment duration of a minimum of 3 years from the time of the last patient randomized to a maximum of 5 years.

Condition Intervention Phase
Aortic Stenosis
Drug: Rosuvastatin
Drug: Placebo
Phase III

MedlinePlus related topics: Cholesterol
Drug Information available for: Rosuvastatin Rosuvastatin calcium Cholest-5-en-3-ol (3beta)-
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Efficacy Study
Official Title: Effect of Cholesterol Lowering on the Progression of Aortic Stenosis in Patients With Mild to Moderate Aortic Stenosis (ASTRONOMER)Aortic Stenosis Progression Observation Measuring Effects of Rosuvastatin and The Sub-Study Protocol.

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The changes in transvalvular aortic velocities and the changes in aortic valve area. [ Time Frame: Between baseline and close-out measurments. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The incidence and severity of adverse events, the clinically relevant changes in echocardiograms, and laboratory analysis will be compared between the two treatment groups. [ Time Frame: Baseline and minimum of 3 year follow-up. ] [ Designated as safety issue: No ]
  • The incidence and severity of adverse events, the clinically relevant changes in echocardiograms, and laboratory analysis will be compared between the two treatment groups. [ Time Frame: Between baseline and close-out measurments. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 378
Study Start Date: November 2002
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Rosuvastatin 40 mg
Drug: Rosuvastatin
40 mg, oral, single dose
2: Placebo Comparator
Drug: Placebo
oral, single dose


Ages Eligible for Study:   18 Years to 82 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Mild to moderate AS defined by peak Doppler aortic valve velocity 2.5 to 4 m/sec
  • Baseline LDL-C value must be within targeted level for all risk categories according to the Canadian Guidelines
  • Baseline triglyceride levels must be within target level for the risk categories

Exclusion Criteria:

  • Very mild AS defined by peak Doppler AS velocity <2.5m/sec, because the rate of progression is not well defined; Females of child bearing potential who do not practice adequate contraception.
  • Severe AS defined by peak Doppler AS velocity > 4m/sec. These patients are excluded because they will have a high probability of aortic valve replacement even without further AS progression.
  • Greater than moderate aortic regurgitation, defined as aortic jet width to aortic outflow tract ratio >0.45; Patients with diabetes or with a fasting blood sugar level > 7.0 mmol/L (must be confirmed with one repeat assay within 14 days).
  • Significant concomitant mitral valve disease, defined by > moderate mitral regurgitation (MR) or mitral valve area (MVA)< 1.5 cm2; A very high risk of CAD (10 year risk > 30%), according to the Canadian Guidelines.
  Contacts and Locations
Please refer to this study by its identifier: NCT00800800

Contact: AstraZeneca Canada Inc 800-565-5877 ext 6864

Research site Recruiting
St. John's, Canada
Research site Recruiting
Halifax, Canada
Canada, Alberta
Research site Recruiting
Calgary, Alberta, Canada
Research site Recruiting
Edmonton, Alberta, Canada
Canada, British Columbia
Research site Recruiting
Vancouver, British Columbia, Canada
Research site Recruiting
Victoria, British Columbia, Canada
Research site Recruiting
Surrey, British Columbia, Canada
Canada, Manitoba
Research site Recruiting
Edmonton, Manitoba, Canada
Canada, Ontario
Research site Recruiting
Ottawa, Ontario, Canada
Research site Recruiting
Toronto, Ontario, Canada
Research site Recruiting
Kitchener, Ontario, Canada
Research site Recruiting
Montreal, Ontario, Canada
Research site Recruiting
Brampton, Ontario, Canada
Research site Recruiting
Cambridge, Ontario, Canada
Canada, Quebec
Research site Recruiting
Montreal, Quebec, Canada
Sponsors and Collaborators
University of Ottawa Heart Institute
  More Information

Responsible Party: AstraZeneca Canada ( Andrew Vieira )
Study ID Numbers: DC-452-0003
Study First Received: November 25, 2008
Last Updated: December 1, 2008 Identifier: NCT00800800  
Health Authority: Canada: Canadian Institutes of Health Research;   Canada: Ethics Review Committee;   Canada: Health Canada

Keywords provided by AstraZeneca:
progression of aortic stenosis

Study placed in the following topic categories:
Pathological Conditions, Anatomical
Heart Diseases
Disease Progression
Constriction, Pathologic
Aortic valve stenosis
Aortic Valve Stenosis
Heart Valve Diseases

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Enzyme Inhibitors
Cardiovascular Diseases
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Ventricular Outflow Obstruction processed this record on January 13, 2009