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Effects of Rosuvastatin on Aortic Stenosis Progression (ASTRONOMER)

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ClinicalTrials.gov Identifier: NCT00800800
Recruitment Status : Completed
First Posted : December 2, 2008
Last Update Posted : December 3, 2010
Sponsor:
Collaborator:
Ottawa Heart Institute Research Corporation
Information provided by:
AstraZeneca

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Aortic Stenosis Drug: Rosuvastatin Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 378 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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.
Study Start Date : November 2002
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
Rosuvastatin 40 mg
 Drug: Rosuvastatin
40 mg, oral, single dose
Placebo Comparator: 2
placebo
 Drug: Placebo
oral, single dose


Outcome Measures
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Primary Outcome Measures :
  1. The changes in transvalvular aortic velocities and the changes in aortic valve area. [ Time Frame: Between baseline and close-out measurments. ]

Secondary Outcome Measures :
  1. 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. ]
  2. 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. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 82 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00800800


Locations
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Canada, Alberta
Research site
Calgary, Alberta, Canada
Research site
Edmonton, Alberta, Canada
Canada, British Columbia
Research site
Surrey, British Columbia, Canada
Research site
Vancouver, British Columbia, Canada
Research site
Victoria, British Columbia, Canada
Canada, Manitoba
Research site
Edmonton, Manitoba, Canada
Canada, Ontario
Research site
Brampton, Ontario, Canada
Research site
Cambridge, Ontario, Canada
Research site
Kitchener, Ontario, Canada
Research site
Montreal, Ontario, Canada
Research site
Ottawa, Ontario, Canada
Research site
Toronto, Ontario, Canada
Canada, Quebec
Research site
Montreal, Quebec, Canada
Canada
Research site
Halifax, Canada
Research site
St. John's, Canada
Sponsors and Collaborators
AstraZeneca
Ottawa Heart Institute Research Corporation
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Andrew Vieira, AstraZeneca Canada
ClinicalTrials.gov Identifier: NCT00800800    
Other Study ID Numbers: DC-452-0003
First Posted: December 2, 2008    Key Record Dates
Last Update Posted: December 3, 2010
Last Verified: December 2010
Keywords provided by AstraZeneca:
progression of aortic stenosis
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Constriction, Pathologic
Disease Progression
Pathological Conditions, Anatomical
Disease Attributes
Pathologic Processes
Aortic Valve Disease
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
 Ventricular Outflow Obstruction
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors