Status:
COMPLETED
Effects of Rosuvastatin on Aortic Stenosis Progression
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Ottawa Heart Institute Research Corporation
Conditions:
Aortic Stenosis
Eligibility:
All Genders
18-82 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2008
Estimated Enrollment :
378 Patients enrolled
Trial Details
Trial ID
NCT00800800
Start Date
November 1 2002
End Date
September 1 2008
Last Update
December 3 2010
Active Locations (15)
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1
Research site
Calgary, Alberta, Canada
2
Research site
Edmonton, Alberta, Canada
3
Research site
Surrey, British Columbia, Canada
4
Research site
Vancouver, British Columbia, Canada