drugset / Trial / NCT00000599
Cholesterol-Lowering Atherosclerosis Study (CLAS)
RandomizedTreatment
Summary
To determine whether combined therapy with the lipid lowering agents colestipol hydrochloride plus niacin would produce significant change in coronary, carotid, and femoral artery atherosclerosis and coronary bypass graft lesions as determined by angiography. Also, to determine possible correlations between lesion changes and plasma lipid and lipoprotein cholesterol levels and to explore interrelationships of atherosclerosis change in femoral, coronary, and carotid arteries.
Timeline
- Start
- 1980-06
- Primary completion
- —
- Completion
- 1994-11
Publications
- Background Azen SP, Cashin-Hemphill L, Pogoda J, Mack WJ, Sanmarco ME, Wickham E, Blankenhorn DH. Evaluation of human panelists in assessing coronary atherosclerosis. Arterioscler Thromb. 1991 Mar-Apr;11(2):385-94. doi: 10.1161/01.atv.11.2.385.
- Background Blankenhorn DH, Azen SP, Crawford DW, Nessim SA, Sanmarco ME, Selzer RH, Shircore AM, Wickham EC. Effects of colestipol-niacin therapy on human femoral atherosclerosis. Circulation. 1991 Feb;83(2):438-47. doi: 10.1161/01.cir.83.2.438.
- Background Blankenhorn DH, Selzer RH, Mack WJ, Crawford DW, Pogoda J, Lee PL, Shircore AM, Azen SP. Evaluation of colestipol/niacin therapy with computer-derived coronary end point measures. A comparison of different measures of treatment effect. Circulation. 1992 Dec;86(6):1701-9. doi: 10.1161/01.cir.86.6.1701.
- Background Mack WJ, Selzer RH, Pogoda JM, Lee PL, Shircore AM, Azen SP, Blankenhorn DH; New Collective Author. Comparison of computer- and human-derived coronary angiographic end-point measures for controlled therapy trials. Arterioscler Thromb. 1992 Mar;12(3):348-56. doi: 10.1161/01.atv.12.3.348.
- Background Mack WJ, Selzer RH, Hodis HN, Erickson JK, Liu CR, Liu CH, Crawford DW, Blankenhorn DH. One-year reduction and longitudinal analysis of carotid intima-media thickness associated with colestipol/niacin therapy. Stroke. 1993 Dec;24(12):1779-83. doi: 10.1161/01.str.24.12.1779.
- Background Blankenhorn DH, Selzer RH, Crawford DW, Barth JD, Liu CR, Liu CH, Mack WJ, Alaupovic P. Beneficial effects of colestipol-niacin therapy on the common carotid artery. Two- and four-year reduction of intima-media thickness measured by ultrasound. Circulation. 1993 Jul;88(1):20-8. doi: 10.1161/01.cir.88.1.20.
- Background Blankenhorn DH, Johnson RL, Nessim SA, Azen SP, Sanmarco ME, Selzer RH. The Cholesterol Lowering Atherosclerosis Study (CLAS): design, methods, and baseline results. Control Clin Trials. 1987 Dec;8(4):356-87. doi: 10.1016/0197-2456(87)90156-5.
- Background Blankenhorn DH, Nessim SA, Johnson RL, Sanmarco ME, Azen SP, Cashin-Hemphill L. Beneficial effects of combined colestipol-niacin therapy on coronary atherosclerosis and coronary venous bypass grafts. JAMA. 1987 Jun 19;257(23):3233-40.
- Background Cashin-Hemphill L, Mack WJ, Pogoda JM, Sanmarco ME, Azen SP, Blankenhorn DH. Beneficial effects of colestipol-niacin on coronary atherosclerosis. A 4-year follow-up. JAMA. 1990 Dec 19;264(23):3013-7.
- Background Mack WJ, Blankenhorn DH. Factors influencing the formation of new human coronary lesions: age, blood pressure, and blood cholesterol. Am J Public Health. 1991 Sep;81(9):1180-4. doi: 10.2105/ajph.81.9.1180.
- Background Azen SP, Qian D, Mack WJ, Sevanian A, Selzer RH, Liu CR, Liu CH, Hodis HN. Effect of supplementary antioxidant vitamin intake on carotid arterial wall intima-media thickness in a controlled clinical trial of cholesterol lowering. Circulation. 1996 Nov 15;94(10):2369-72. doi: 10.1161/01.cir.94.10.2369.
- Background Hodis HN, Mack WJ, LaBree L, Cashin-Hemphill L, Sevanian A, Johnson R, Azen SP. Serial coronary angiographic evidence that antioxidant vitamin intake reduces progression of coronary artery atherosclerosis. JAMA. 1995 Jun 21;273(23):1849-54.
- Background Azen SP, Mack WJ, Cashin-Hemphill L, LaBree L, Shircore AM, Selzer RH, Blankenhorn DH, Hodis HN. Progression of coronary artery disease predicts clinical coronary events. Long-term follow-up from the Cholesterol Lowering Atherosclerosis Study. Circulation. 1996 Jan 1;93(1):34-41. doi: 10.1161/01.cir.93.1.34.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Colestipol | Unknown | 30 g | — |
| Subject | Niacin | Small molecule | 3 g | — |
| Subject | Niacin | Small molecule | 12 g | — |