Diener Hans-Christoph
University Duisburg-Essen, Department of Neurology, Hufelandstrasse 55, 45122 Essen, Germany.
Expert Rev Neurother. 2007 Sep;7(9):1085-91. doi: 10.1586/14737175.7.9.1085.
Patients with transient ischemic attack and ischemic stroke have a high risk of recurrent stroke and death. While aspirin is accepted as standard therapy in these patients, recent trials demonstrate that a combination of aspirin and extended-release dipyridamole or clopidogrel is superior to aspirin monotherapy. Blockade of the renin-angiotensin system with angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers may also reduce recurrent stroke. The ongoing Prevention Regimen for Effectively Avoiding Second Strokes (PRoFESS) trial is designed to evaluate whether extended-release dipyridamole plus aspirin compared with clopidogrel, and whether telmisartan in addition to usual care, in individuals after a stroke, will reduce the risk of further strokes. PRoFESS is a multicenter, randomized, double-blind trial involving 695 sites from 35 countries or regions. The primary outcome for the trial is recurrent stroke, using a time-to-event analysis. Safety is evaluated by assessing the risk of major hemorrhagic and other serious adverse events. With over 20,000 patients randomized, and utilizing a 2 x 2 factorial design, PRoFESS is the largest stroke trial to investigate the prevention of recurrent stroke.
短暂性脑缺血发作和缺血性脑卒中患者有较高的复发性脑卒中风险及死亡风险。虽然阿司匹林被公认为这些患者的标准治疗药物，但近期试验表明，阿司匹林与缓释双嘧达莫或氯吡格雷联合使用优于阿司匹林单药治疗。使用血管紧张素转换酶抑制剂或血管紧张素受体阻滞剂阻断肾素-血管紧张素系统也可能降低复发性脑卒中的风险。正在进行的有效避免二次卒中预防方案（PRoFESS）试验旨在评估，对于卒中后的个体，缓释双嘧达莫加阿司匹林与氯吡格雷相比，以及替米沙坦在常规治疗基础上是否会降低再次发生卒中的风险。PRoFESS是一项多中心、随机、双盲试验，涉及来自35个国家或地区的695个地点。该试验的主要结局是复发性脑卒中，采用事件发生时间分析。通过评估重大出血及其他严重不良事件的风险来评估安全性。PRoFESS随机纳入了超过20000名患者，并采用2×2析因设计，是调查复发性脑卒中预防的最大规模的卒中试验。
