Effects of Rosuvastatin on Aortic Stenosis Progression

Aortic Stenosis Clinical Trial

— ASTRONOMER  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00800800
• Other study ID #: DC-452-0003
• Status: Completed
• Phase: Phase 3
• First received: November 25, 2008
• Last updated: December 2, 2010
• Start date: November 2002
• Est. completion date: September 2008

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health ResearchCanada: Ethics Review CommitteeCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 378
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 82 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic
• Disease Progression

Intervention

Drug:
• Rosuvastatin
40 mg, oral, single dose
• Placebo
oral, single dose

Locations

Country	Name	City	State
Canada	Research site	Brampton	Ontario
Canada	Research site	Calgary	Alberta
Canada	Research site	Cambridge	Ontario
Canada	Research site	Edmonton	Alberta
Canada	Research site	Edmonton	Manitoba
Canada	Research site	Halifax
Canada	Research site	Kitchener	Ontario
Canada	Research site	Montreal	Ontario
Canada	Research site	Montreal	Quebec
Canada	Research site	Ottawa	Ontario
Canada	Research site	St. John's
Canada	Research site	Surrey	British Columbia
Canada	Research site	Toronto	Ontario
Canada	Research site	Vancouver	British Columbia
Canada	Research site	Victoria	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The changes in transvalvular aortic velocities and the changes in aortic valve area.		Between baseline and close-out measurments.	No
Secondary	The incidence and severity of adverse events, the clinically relevant changes in echocardiograms, and laboratory analysis will be compared between the two treatment groups.		Baseline and minimum of 3 year follow-up.	No
Secondary	The incidence and severity of adverse events, the clinically relevant changes in echocardiograms, and laboratory analysis will be compared between the two treatment groups.		Between baseline and close-out measurments.	Yes