Effects of Rosuvastatin on Aortic Stenosis Progression

Last updated: December 2, 2010
Sponsor: AstraZeneca
Overall Status: Completed

Phase

3

Condition

Heart Defect

Congestive Heart Failure

Treatment

N/A

Clinical Study ID

NCT00800800
DC-452-0003
  • Ages 18-82
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 accordingto the Canadian Guidelines

  • Baseline triglyceride levels must be within target level for the risk categories

Exclusion

Exclusion Criteria:

  • Very mild AS defined by peak Doppler AS velocity <2.5m/sec, because the rate ofprogression is not well defined; Females of child bearing potential who do notpractice adequate contraception.

  • Severe AS defined by peak Doppler AS velocity > 4m/sec. These patients are excludedbecause they will have a high probability of aortic valve replacement even withoutfurther AS progression.

  • Greater than moderate aortic regurgitation, defined as aortic jet width to aorticoutflow 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 mitralregurgitation (MR) or mitral valve area (MVA)< 1.5 cm2; A very high risk of CAD (10year risk > 30%), according to the Canadian Guidelines.

Study Design

Total Participants: 378
Study Start date:
November 01, 2002
Estimated Completion Date:
September 30, 2008

Connect with a study center

  • Research site

    Calgary, Alberta
    Canada

    Site Not Available

  • Research site

    Edmonton, Alberta
    Canada

    Site Not Available

  • Research site

    Surrey, British Columbia
    Canada

    Site Not Available

  • Research site

    Vancouver, British Columbia
    Canada

    Site Not Available

  • Research site

    Victoria, British Columbia
    Canada

    Site Not Available

  • Research site

    Brampton, Ontario
    Canada

    Site Not Available

  • Research site

    Cambridge, Ontario
    Canada

    Site Not Available

  • Research site

    Kitchener, Ontario
    Canada

    Site Not Available

  • Research site

    Ottawa, Ontario
    Canada

    Site Not Available

  • Research site

    Toronto, Ontario
    Canada

    Site Not Available

  • Research site

    Montreal, Quebec
    Canada

    Site Not Available

  • Research site

    Halifax,
    Canada

    Site Not Available

  • Research site

    St. John's,
    Canada

    Site Not Available

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