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Effects of Rosuvastatin on Aortic Stenosis Progression

NCT ID: NCT00800800

Last Updated: 2010-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

378 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2008-09-30

Brief Summary

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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

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Conditions

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Aortic Stenosis

Keywords

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progression of aortic stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Rosuvastatin 40 mg

Group Type ACTIVE_COMPARATOR

Rosuvastatin

Intervention Type DRUG

40 mg, oral, single dose

2

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral, single dose

Interventions

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Rosuvastatin

40 mg, oral, single dose

Intervention Type DRUG

Placebo

oral, single dose

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

82 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Canada

Locations

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Research site

Calgary, Alberta, Canada

Site Status

Research site

Edmonton, Alberta, Canada

Site Status

Research site

Surrey, British Columbia, Canada

Site Status

Research site

Vancouver, British Columbia, Canada

Site Status

Research site

Victoria, British Columbia, Canada

Site Status

Research site

Edmonton, Manitoba, Canada

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Research site

Brampton, Ontario, Canada

Site Status

Research site

Cambridge, Ontario, Canada

Site Status

Research site

Kitchener, Ontario, Canada

Site Status

Research site

Montreal, Ontario, Canada

Site Status

Research site

Ottawa, Ontario, Canada

Site Status

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Toronto, Ontario, Canada

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Research site

Montreal, Quebec, Canada

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Research site

Halifax, , Canada

Site Status

Research site

St. John's, , Canada

Site Status

Countries

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Canada

References

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Capoulade R, Torzewski M, Mayr M, Chan KL, Mathieu P, Bosse Y, Dumesnil JG, Tam J, Teo KK, Burnap SA, Schmid J, Gobel N, Franke UFW, Sanchez A, Witztum JL, Yang X, Yeang C, Arsenault B, Despres JP, Pibarot P, Tsimikas S. ApoCIII-Lp(a) complexes in conjunction with Lp(a)-OxPL predict rapid progression of aortic stenosis. Heart. 2020 May;106(10):738-745. doi: 10.1136/heartjnl-2019-315840. Epub 2020 Feb 13.

Reference Type DERIVED
PMID: 32054669 (View on PubMed)

Capoulade R, Yeang C, Chan KL, Pibarot P, Tsimikas S. Association of Mild to Moderate Aortic Valve Stenosis Progression With Higher Lipoprotein(a) and Oxidized Phospholipid Levels: Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2018 Dec 1;3(12):1212-1217. doi: 10.1001/jamacardio.2018.3798.

Reference Type DERIVED
PMID: 30476957 (View on PubMed)

Capoulade R, Chan KL, Mathieu P, Bosse Y, Dumesnil JG, Tam JW, Teo KK, Yang X, Witztum JL, Arsenault BJ, Despres JP, Pibarot P, Tsimikas S. Autoantibodies and immune complexes to oxidation-specific epitopes and progression of aortic stenosis: Results from the ASTRONOMER trial. Atherosclerosis. 2017 May;260:1-7. doi: 10.1016/j.atherosclerosis.2017.03.013. Epub 2017 Mar 9.

Reference Type DERIVED
PMID: 28319871 (View on PubMed)

Capoulade R, Chan KL, Yeang C, Mathieu P, Bosse Y, Dumesnil JG, Tam JW, Teo KK, Mahmut A, Yang X, Witztum JL, Arsenault BJ, Despres JP, Pibarot P, Tsimikas S. Oxidized Phospholipids, Lipoprotein(a), and Progression of Calcific Aortic Valve Stenosis. J Am Coll Cardiol. 2015 Sep 15;66(11):1236-1246. doi: 10.1016/j.jacc.2015.07.020.

Reference Type DERIVED
PMID: 26361154 (View on PubMed)

Page A, Dumesnil JG, Clavel MA, Chan KL, Teo KK, Tam JW, Mathieu P, Despres JP, Pibarot P; ASTRONOMER Investigators. Metabolic syndrome is associated with more pronounced impairment of left ventricle geometry and function in patients with calcific aortic stenosis: a substudy of the ASTRONOMER (Aortic Stenosis Progression Observation Measuring Effects of Rosuvastatin). J Am Coll Cardiol. 2010 Apr 27;55(17):1867-74. doi: 10.1016/j.jacc.2009.11.083.

Reference Type DERIVED
PMID: 20413039 (View on PubMed)

Other Identifiers

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DC-452-0003

Identifier Type: -

Identifier Source: org_study_id