drugset / Trial / NCT00800800
Effects of Rosuvastatin on Aortic Stenosis Progression
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2002-11
- Primary completion
- 2008-09
- Completion
- 2008-09
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Rosuvastatin | Small molecule | 40 mg | Oral |