Zanchetti Alberto, Liu Lisheng, Mancia Giuseppe, Parati Gianfranco, Grassi Guido, Stramba-Badiale Marco, Silani Vincenzo, Bilo Grzegorz, Corrao Giovanni, Zambon Antonella, Scotti Lorenza, Zhang Xinhua, Wang HayYan, Zhang Yuqing, Zhang Xuezhong, Guan Ting Rui, Berge Eivind, Redon Josep, Narkiewicz Krzysztof, Dominiczak Anna, Nilsson Peter, Viigimaa Margus, Laurent Stéphane, Agabiti-Rosei Enrico, Wu Zhaosu, Zhu Dingliang, Rodicio José Luis, Ruilope Luis Miguel, Martell-Claros Nieves, Pinto Fernando, Schmieder Roland E, Burnier Michel, Banach Maciej, Cifkova Renata, Farsang Csaba, Konradi Alexandra, Lazareva Irina, Sirenko Yuriy, Dorobantu Maria, Postadzhiyan Arman, Accetto Rok, Jelakovic Bojan, Lovic Dragan, Manolis Athanasios J, Stylianou Philippos, Erdine Serap, Dicker Dror, Wei Gangzhi, Xu Chengbin, Xie Hengge, Coca Antonio, O'Brien John, Ford Gary
aIstituto Auxologico Italiano bUniversità di Milano, Milan, Italy cFuWai Hospital and Cardiovascular Institute dBeijing Hypertension League Institute, Beijing, China eUniversità Milano-Bicocca fIRCCS Multimedica, Sesto San Giovanni, Milan, Italy gOslo University Hospital, Oslo, Norway hUniversity of Valencia, Madrid, Spain iMedical University of Gdansk, Gdansk, Poland jUniversity of Glasgow, Glasgow, UK kLund University, Scania University Hospital, Malmö, Sweden lTallinn University of Technology, Tallinn, Estonia mEuropean Hospital Georges Pompidou, Paris, France nUniversità di Brescia, Spedali Civili, Brescia, Italy oBeijing Anzhen Hospital, Beijing pShanghai Hypertension Institute, China qComplutense University rHospital 12 de Octubre sHospital Clínico San Carlos, Madrid, Spain tCentro Hospitalar de Entre o Douro e Vouga, E.P.E., Portugal uNephrology and Hypertension, University Hospital, Erlangen, Germany vUniversity Hospital of Lausanne, Lausanne, Switzerland wMedical University of Lodz, Poland xCharles University Medical School I and Thomayer Hospital, Prague, Czech Republic ySt. Imre University Teaching Hospital, Budapest, Hungary zAlmazov Federal Heart, Blood and Endocrinology Center, St. Petersburg, Russia aaRSPC Cardiology, Minsk, Belarus abNSC 'Institute of Cardiology named after N.D. Strazhesko' of NAMS, Kiev, Ukraine acEmergency Hospital of Bucharest, Romania adUniversity Hospital Saint Anna, Sofia, Bulgaria aeDr Peter Drzai Hospital, Ljubljana, Slovenia afUniversity Hospital Center Zagreb, Croatia agClinic for Internal Medicine InterMedic, Nis, Serbia ahCardiology Department, Asklepeion General Hospital, Athens, Greece aiNicosia General Hospital, Nicosia, Cyprus ajIstanbul University Cerrahpaşa School of Medicine, Istanbul, Turkey akHasharon Hospital - Rabin Medical Center, Petach-Tikva, Israel alBeijing Xuanwu Hospital amSecond Affiliate Hospital, Beijing University anMilitary General Hospital, China aoHospital Clinic. University of Barcelona, Ba
J Hypertens. 2014 Sep;32(9):1888-97. doi: 10.1097/HJH.0000000000000254.
The SBP values to be achieved by antihypertensive therapy in order to maximize reduction of cardiovascular outcomes are unknown; neither is it clear whether in patients with a previous cardiovascular event, the optimal values are lower than in the low-to-moderate risk hypertensive patients, or a more cautious blood pressure (BP) reduction should be obtained. Because of the uncertainty whether 'the lower the better' or the 'J-curve' hypothesis is correct, the European Society of Hypertension and the Chinese Hypertension League have promoted a randomized trial comparing antihypertensive treatment strategies aiming at three different SBP targets in hypertensive patients with a recent stroke or transient ischaemic attack. As the optimal level of low-density lipoprotein cholesterol (LDL-C) level is also unknown in these patients, LDL-C-lowering has been included in the design.
The European Society of Hypertension-Chinese Hypertension League Stroke in Hypertension Optimal Treatment trial is a prospective multinational, randomized trial with a 3 × 2 factorial design comparing: three different SBP targets (1, <145-135; 2, <135-125; 3, <125 mmHg); two different LDL-C targets (target A, 2.8-1.8; target B, <1.8 mmol/l). The trial is to be conducted on 7500 patients aged at least 65 years (2500 in Europe, 5000 in China) with hypertension and a stroke or transient ischaemic attack 1-6 months before randomization. Antihypertensive and statin treatments will be initiated or modified using suitable registered agents chosen by the investigators, in order to maintain patients within the randomized SBP and LDL-C windows. All patients will be followed up every 3 months for BP and every 6 months for LDL-C. Ambulatory BP will be measured yearly.
Primary outcome is time to stroke (fatal and non-fatal). Important secondary outcomes are: time to first major cardiovascular event; cognitive decline (Montreal Cognitive Assessment) and dementia. All major outcomes will be adjudicated by committees blind to randomized allocation. A Data and Safety Monitoring Board has open access to data and can recommend trial interruption for safety.
It has been calculated that 925 patients would reach the primary outcome after a mean 4-year follow-up, and this should provide at least 80% power to detect a 25% stroke difference between SBP targets and a 20% difference between LDL-C targets.
为最大程度降低心血管事件风险，抗高血压治疗应达到的收缩压（SBP）值尚不清楚；既往有心血管事件的患者，其最佳血压值是否低于低至中度风险的高血压患者，或者是否应更谨慎地降低血压，也不明确。由于不确定“越低越好”还是“J曲线”假说正确，欧洲高血压学会和中国高血压联盟开展了一项随机试验，比较针对近期发生中风或短暂性脑缺血发作的高血压患者，旨在实现三个不同SBP目标的抗高血压治疗策略。由于这些患者的低密度脂蛋白胆固醇（LDL-C）最佳水平也未知，因此在试验设计中纳入了降低LDL-C的内容。
欧洲高血压学会-中国高血压联盟高血压患者中风最佳治疗试验是一项前瞻性跨国随机试验，采用3×2析因设计，比较：三个不同的SBP目标（1，<145 - 135；2，<135 - 125；3，<125 mmHg）；两个不同的LDL-C目标（目标A，2.8 - 1.8；目标B，<1.8 mmol/l）。该试验将纳入7500例年龄至少65岁的患者（欧洲2500例，中国5000例），这些患者患有高血压，且在随机分组前1 - 6个月发生过中风或短暂性脑缺血发作。将使用研究人员选择的合适的注册药物启动或调整抗高血压和他汀类药物治疗，以使患者维持在随机分配的SBP和LDL-C范围内。所有患者每3个月随访一次血压，每6个月随访一次LDL-C。每年测量动态血压。
主要结局指标是中风发生时间（致命性和非致命性）。重要的次要结局指标包括：首次发生重大心血管事件的时间；认知功能下降（蒙特利尔认知评估）和痴呆。所有主要结局将由对随机分组不知情的委员会进行判定。数据与安全监测委员会可直接获取数据，并可因安全性原因建议中断试验。
据计算，平均4年随访后925例患者将达到主要结局指标，这应能提供至少80%的检验效能，以检测SBP目标之间25%的中风差异以及LDL-C目标之间20%的差异。
