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Completed

NCT Number: NCT00800800

Effects of Rosuvastatin on Aortic Stenosis Progression

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.

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Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year–82 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research site, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rosuvastatin

Drug

40 mg, oral, single dose

Placebo

Drug

oral, single dose

Primary outcomes

  1. The changes in transvalvular aortic velocities and the changes in aortic valve area.

    Time frame: Between baseline and close-out measurments.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Ottawa Heart Institute Research Corporation

Registry information

Official study 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.

Acronym: ASTRONOMER

Important dates

Study start
2002
Primary completion
2008
Study completion
2008
First posted
Dec 2, 2008
Registry last updated
Dec 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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