drugset / Trial / NCT00590135
The Effect of Lipitor on Aortic Stenosis
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to find out if an approved medicine that is used to lower cholesterol called Lipitor can slow or stop progressive narrowing of the aortic heart valve in patients with a condition called aortic stenosis. Patients who have aortic stenosis who volunteer for this study will take Lipitor for 2 years and will undergo a brief exam by a physician, labwork to measure cholesterol, and a routine heart ultrasound (sound picture of the heart) at the start of the study and every 6 months, stopping at 2 years.
Timeline
- Start
- 2000-08
- Primary completion
- 2010-04-26
- Completion
- 2010-04-26
Outcome
Outcome not reported
Stopped: “Poor Reducibility - primary endpoint measure not obtainable”
Publications
- Background Passik CS, Ackermann DM, Pluth JR, Edwards WD. Temporal changes in the causes of aortic stenosis: a surgical pathologic study of 646 cases. Mayo Clin Proc. 1987 Feb;62(2):119-23. doi: 10.1016/s0025-6196(12)61880-1.
- Background Walton KW, Williamson N, Johnson AG. The pathogenesis of atherosclerosis of the mitral and aortic valves. J Pathol. 1970 Jul;101(3):205-20. doi: 10.1002/path.1711010302. No abstract available.
- Background Otto CM, Kuusisto J, Reichenbach DD, Gown AM, O'Brien KD. Characterization of the early lesion of 'degenerative' valvular aortic stenosis. Histological and immunohistochemical studies. Circulation. 1994 Aug;90(2):844-53. doi: 10.1161/01.cir.90.2.844.
- Background Kawaguchi A, Miyatake K, Yutani C, Beppu S, Tsushima M, Yamamura T, Yamamoto A. Characteristic cardiovascular manifestation in homozygous and heterozygous familial hypercholesterolemia. Am Heart J. 1999 Mar;137(3):410-8. doi: 10.1016/s0002-8703(99)70485-0.
- Background O'Brien KD, Reichenbach DD, Marcovina SM, Kuusisto J, Alpers CE, Otto CM. Apolipoproteins B, (a), and E accumulate in the morphologically early lesion of 'degenerative' valvular aortic stenosis. Arterioscler Thromb Vasc Biol. 1996 Apr;16(4):523-32. doi: 10.1161/01.atv.16.4.523.
- Background Chan KL, Ghani M, Woodend K, Burwash IG. Case-controlled study to assess risk factors for aortic stenosis in congenitally bicuspid aortic valve. Am J Cardiol. 2001 Sep 15;88(6):690-3. doi: 10.1016/s0002-9149(01)01820-3. No abstract available.
- Background Hofmann T, Kasper W, Meinertz T, Spillner G, Schlosser V, Just H. Determination of aortic valve orifice area in aortic valve stenosis by two-dimensional transesophageal echocardiography. Am J Cardiol. 1987 Feb 1;59(4):330-5. doi: 10.1016/0002-9149(87)90808-3.
- Background Stoddard MF, Arce J, Liddell NE, Peters G, Dillon S, Kupersmith J. Two-dimensional transesophageal echocardiographic determination of aortic valve area in adults with aortic stenosis. Am Heart J. 1991 Nov;122(5):1415-22. doi: 10.1016/0002-8703(91)90585-6.
- Background Otto CM, Pearlman AS, Gardner CL. Hemodynamic progression of aortic stenosis in adults assessed by Doppler echocardiography. J Am Coll Cardiol. 1989 Mar 1;13(3):545-50. doi: 10.1016/0735-1097(89)90590-1.
- Background Roger VL, Tajik AJ, Bailey KR, Oh JK, Taylor CL, Seward JB. Progression of aortic stenosis in adults: new appraisal using Doppler echocardiography. Am Heart J. 1990 Feb;119(2 Pt 1):331-8. doi: 10.1016/s0002-8703(05)80024-9.
- Background Faggiano P, Ghizzoni G, Sorgato A, Sabatini T, Simoncelli U, Gardini A, Rusconi C. Rate of progression of valvular aortic stenosis in adults. Am J Cardiol. 1992 Jul 15;70(2):229-33. doi: 10.1016/0002-9149(92)91280-h.
- Background Peter M, Hoffmann A, Parker C, Luscher T, Burckhardt D. Progression of aortic stenosis. Role of age and concomitant coronary artery disease. Chest. 1993 Jun;103(6):1715-9. doi: 10.1378/chest.103.6.1715.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atorvastatin | Small molecule | 40 mg | Oral |