Effects of Rosuvastatin on Aortic Stenosis Progression

Phase 3

Completed

• Conditions: Aortic Stenosis
• Interventions: Drug: Rosuvastatin; Drug: Placebo

• Registration Number: NCT00800800
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Study First Submitted: 2008-11-25
• Study First Submitted QC: 2008-12-01
• Study First Posted: 2008-12-02
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-02
• Last Update Posted: 2010-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 378

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Rosuvastatin	Rosuvastatin 40 mg
2	Placebo	placebo

Primary Outcome Measures

Name	Time	Method
The changes in transvalvular aortic velocities and the changes in aortic valve area.	Between baseline and close-out measurments.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Research site; 🇨🇦 St. John's, Canada