Effects of Rosuvastatin on Aortic Stenosis Progression - Full Text View

Sponsor:	AstraZeneca
Collaborator:	University of Ottawa Heart Institute
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00800800

Purpose

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol

Drug Information available for: Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

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
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Rosuvastatin 40 mg	Drug: Rosuvastatin 40 mg, oral, single dose
Placebo Comparator: 2 placebo	Drug: Placebo oral, single dose

Eligibility

Ages Eligible for Study:	18 Years to 82 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00800800

Locations

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
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Kitchener, Ontario, Canada
Research site
Montreal, Ontario, Canada
Research site
Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
Canada, Quebec
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Montreal, Quebec, Canada
Canada
Research site
Halifax, Canada
Research site
St. John's, Canada

Sponsors and Collaborators

AstraZeneca

University of Ottawa Heart Institute

More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pagé A, Dumesnil JG, Clavel MA, Chan KL, Teo KK, Tam JW, Mathieu P, Després JP, Pibarot P; ASTRONOMER Investigators. Metabolic syndrome is associated with more pronounced impairment of left ventricle geometry and function in patients with calcific aortic stenosis: a substudy of the ASTRONOMER (Aortic Stenosis Progression Observation Measuring Effects of Rosuvastatin). J Am Coll Cardiol. 2010 Apr 27;55(17):1867-74.

Responsible Party:	Andrew Vieira, AstraZeneca Canada
ClinicalTrials.gov Identifier:	NCT00800800 History of Changes
Other Study ID Numbers:	DC-452-0003
Study First Received:	November 25, 2008
Last Updated:	December 2, 2010
Health Authority:	Canada: Canadian Institutes of Health Research; Canada: Ethics Review Committee; Canada: Health Canada

Keywords provided by AstraZeneca:

progression of aortic stenosis

Additional relevant MeSH terms:

Aortic Valve Stenosis
Constriction, Pathologic
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Pathological Conditions, Anatomical
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 February 09, 2012