This proposal is for an investigator initiated multicenter clinical trial of medical/surgical therapy to prevent stroke in asymptomatic patients with stenosis of the distal common and/or internal carotid artery. There are two components - a surgical and a medical. Surgical. The major aim of the surgical component is to compare the effectiveness of aspirin + endarterectomy versus aspirin alone in reducing the incidence of TIA and cerebral infarction in patients with asymptomatic hemodynamically significant stenosis of the carotid artery. A secondary objective is to determine the incidence of recurrent stenosis following carotid endarterectomy. Medical. The major aim of the medical component is to compare the effectiveness of aspirin versus ibuprofen versus a placebo in reducing the incidence of the primary endpoints of TIA, cerebral infarction, or progression to hemodynamically significant stenosis in patients with asymptomatic non-hemodynamically significant stenosis of the carotid artery. An important secondary aim is to make such a comparison in terms of the secondary endpoint of myocardial infarction or other cardiac ischemia in those patients with no such symptoms. Another secondary objective is to determine the relationship of the progression of carotid stenosis (from non-hemodynamically significant to hemodynamically significant) to the occurrence of cerebral ischemia (TIA or stroke). In the surgical component, follow-up will be for a minimum of five years and will evaluate the frequency and magnitude of subsequent neurological events and the recurrent stenosis rate at the operated site. In the medical component, follow-up will also be for a minimum of five years to evaluate the development of neurological symptoms and the rate of progression of stenosis as assessed by noninvasive studies.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Research Project (R01)
Project #
5R01NS022611-04
Application #
3405237
Study Section
(SRC)
Project Start
1985-09-09
Project End
1992-02-28
Budget Start
1988-03-01
Budget End
1989-02-28
Support Year
4
Fiscal Year
1988
Total Cost
Indirect Cost
Name
Wake Forest University Health Sciences
Department
Type
Schools of Medicine
DUNS #
041418799
City
Winston-Salem
State
NC
Country
United States
Zip Code
27106
Baker, W H; Howard, V J; Howard, G et al. (2000) Effect of contralateral occlusion on long-term efficacy of endarterectomy in the asymptomatic carotid atherosclerosis study (ACAS). ACAS Investigators. Stroke 31:2330-4
Pettigrew, L C; Thomas, N; Howard, V J et al. (2000) Low mini-mental status predicts mortality in asymptomatic carotid arterial stenosis. Asymptomatic Carotid Atherosclerosis Study investigators. Neurology 55:30-4
Moore, W S; Kempczinski, R F; Nelson, J J et al. (1998) Recurrent carotid stenosis : results of the asymptomatic carotid atherosclerosis study. Stroke 29:2018-25
Karanjia, P N; Nelson, J J; Lefkowitz, D S et al. (1997) Validation of the ACAS TIA/stroke algorithm. Neurology 48:346-51
Castaldo, J E; Nelson, J J; Reed 3rd, J F et al. (1997) The delay in reporting symptoms of carotid artery stenosis in an at-risk population. The Asymptomatic Carotid Atherosclerosis Study experience: a statement of concern regarding watchful waiting. Arch Neurol 54:1267-71
Schwartz, S W; Chambless, L E; Baker, W H et al. (1997) Consistency of Doppler parameters in predicting arteriographically confirmed carotid stenosis. Asymptomatic Carotid Atherosclerosis Study Investigators. Stroke 28:343-7
Howard, G; Baker, W H; Chambless, L E et al. (1996) An approach for the use of Doppler ultrasound as a screening tool for hemodynamically significant stenosis (despite heterogeneity of Doppler performance). A multicenter experience. Asymptomatic Carotid Atherosclerosis Study Investigators. Stroke 27:1951-7
Moore, W S; Young, B; Baker, W H et al. (1996) Surgical results: a justification of the surgeon selection process for the ACAS trial. The ACAS Investigators. J Vasc Surg 23:323-8
Young, B; Moore, W S; Robertson, J T et al. (1996) An analysis of perioperative surgical mortality and morbidity in the asymptomatic carotid atherosclerosis study. ACAS Investigators. Asymptomatic Carotid Artheriosclerosis Study. Stroke 27:2216-24
Dean, B L; Lefkowitz, D S; Howard, V J et al. (1996) Comparison of centralized versus ""site-based"" measurement of angiographic stenosis for eligibility in the asymptomatic carotid atherosclerosis study. Invest Radiol 31:446-50

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