Research Project
3409114
The primary objectives are: (i) To determine if the addition of carotid endarterectomy (CE) to optimum medical care for patients with TIA or partial stroke and appropriate carotid stenosis, reduces the risk of subsequent stoke and stroke-related death, (ii) to inquire if major subgroups of patients, specifically those with severe as opposed to moderate stenosis, and those with or without ulceration will benefit from CE. The research focuses on therapy for potential victims of the third leading cause of death and a common cause of long-term disability. It will examine a long-utilized but never-validated procedure to prevent ischemic stroke which was performed approximately 125,000 times in the United States in 1984. The trial will involve 3000 patients entered over a two year period, followed for an average of five years randomly assigned to best medical care or the same plus the addition of carotid endarterectomy. Center eligibility will require proof of skill of participating surgeons, willingness to have a neurologist follow all the patients, and agreement to document at entry and on follow-up visits, data on each patient who is competent and willing to sign consent. In all centers, non- randomized patients will be reported and characterized. Adequate carotid angiography will be mandated prior to randomization. Baseline ultrasound studies will be required and will be repeated in medical and surgical patients at 30 days after entry, after an end-point, at two years and at the conclusion of the trial. "Alerting rules" will ensure that the study will be stopped if there is evidence of harm to patients because of unexpected morbidity from the endarterectomy or because significant benefit is detected in the surgical limb of the study population, or major subgroup thereof. Excluded will be patients: without accessible arteriosclerotic disease appropriate to their symptoms; without symptoms; without informed consent; with a progressing or disabling deficit; with recent M.I.; with organ failure. Patients will be followed for an average of five years, will be documented for all recognized additional risk factors, will be monitored for control of hypertension and for use of appropriate anti-thrombotic agents. The primary analysis will examine the endpoints of fatal and non-fatal stroke, both total and ipsilateral to the randomized lesion. Secondary analyses will look at: major strokes of any type combined with death from any cause; major ischemic strokes ipsilateral to the randomized lesions.
