Effects of Rosuvastatin on Aortic Stenosis Progression (ASTRONOMER)

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Aortic Stenosis

Treatments

Drug: Rosuvastatin

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00800800

DC-452-0003

Details and patient eligibility

About

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.

Enrollment

378 estimated patients

Sex

All

Ages

18 to 82 years old

Volunteers

No Healthy Volunteers

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.