Prospective randomized trial of effects of rosuvastatin on the progression of stenosis in adult patients with congenital aortic stenosis - PROCAS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005962-36-BE

Enrollment

185

Registered

2006-01-10

Start date

2006-03-22

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

congenital aortic stenosis

Interventions

Product Name: CRESTOR Product Code: AZD4522 Pharmaceutical Form: Film-coated tablet Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Predominantly valvular congenital aortic stenosis (aortic stenosis diagnosed before the age of 45 years) with a peak velocity over the valve >2.5m/sec -Age 18-45years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -Current use of statines or other study drug -Aortic stenosis predominantly located sub-valvular or supra-valvular -Aortic insufficiency is predominant to aortic stenosis -Aortic insufficiency >3+ or more -Malignancy in last 2 years -Underwent an aortic valve replacement -Medical history of acute rheumatic disease -Significant mitralic valve disease (MI >2+ or MVA <1.5cm²) Contra indications for use of statines.

Design outcomes

Primary

Measure	Time frame
Main Objective: -is the use of statines in patients with congenital aortic stenosis leading to less rapid progression of stenosis?;Secondary Objective: -Is the effect of statines on the progession of the aortic stenosis determined by lowered cholesterol or by pleiotropic effects of statines? -Is the use of statinies leading to a less rapid progression of the dilatation of the Aortic Ascendens and of Left Ventriclular Hypertrofia in patients with congenital aortic stenosis? -Which factors (clinical, biochemical, echographic) influence the progression of the stenosis in patients with congenital aortic stenosis? -What is the natural course of concomittant atypical conditions (Left Ventriclular Hypertrofia, dilatation of Aortic Ascendens) in patients with aortic stenosis?;Primary end point(s): Progression of grade of aortic stenosis expressed as peak velocity over the aortic valve measured by echocardiography	—

Measure

Time frame

Main Objective: -is the use of statines in patients with congenital aortic stenosis leading to less rapid progression of stenosis?;Secondary Objective: -Is the effect of statines on the progession of the aortic stenosis determined by lowered cholesterol or by pleiotropic effects of statines? -Is the use of statinies leading to a less rapid progression of the dilatation of the Aortic Ascendens and of Left Ventriclular Hypertrofia in patients with congenital aortic stenosis? -Which factors (clinical, biochemical, echographic) influence the progression of the stenosis in patients with congenital aortic stenosis? -What is the natural course of concomittant atypical conditions (Left Ventriclular Hypertrofia, dilatation of Aortic Ascendens) in patients with aortic stenosis?;Primary end point(s): Progression of grade of aortic stenosis expressed as peak velocity over the aortic valve measured by echocardiography

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Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026