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Blood pressure and LDL-cholesterol targets for prevention of recurrent strokes and cognitive decline in the hypertensive patient: design of the European Society of Hypertension-Chinese Hypertension League Stroke in Hypertension Optimal Treatment randomized trial

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机构： [1]Istituto Auxologico Italiano, [2]Universita` di Milano, Milan, Italy, [3]FuWai Hospital and Cardiovascular Institute, [4]Beijing Hypertension League Institute, Beijing, China, [5]Universita` Milano-Bicocca, [6]fIRCCS Multimedica, Sesto San Giovanni, Milan, Italy, [7]Oslo University Hospital, Oslo, Norway, [8]University of Valencia, Madrid, Spain, [9]Medical University of Gdansk, Gdansk, Poland, [10]University of Glasgow, Glasgow,UK, [11]Lund University, Scania University Hospital, Malmo¨ , Sweden, [12]Tallinn University of Technology, Tallinn, Estonia, [13]European Hospital Georges Pompidou, Paris, France, [14]Universita` di Brescia, Spedali Civili, Brescia, Italy, [15]Beijing Anzhen Hospital, Beijing, [16]Shanghai Hypertension Institute, China, [17]Complutense University, [18]Hospital 12 de Octubre, [19]Hospital Cl?′nico San Carlos, Madrid, Spain, [20]Centro Hospitalar de Entre o Douro e Vouga, E.P.E., Portugal, [21]Nephrology and Hypertension, University Hospital,Erlangen, Germany, [22]University Hospital of Lausanne, Lausanne, Switzerland, [23]Medical University of Lodz, Poland, [24]Charles University Medical School I and Thomayer Hospital, Prague, Czech Republic, [25]St. Imre University Teaching Hospital,Budapest, Hungary, [26]Almazov Federal Heart, Blood and Endocrinology Center, St.Petersburg, Russia, [27]RSPC Cardiology, Minsk, Belarus, [28]NSC ‘Institute of Cardiology named after N.D. Strazhesko’ of NAMS, Kiev, Ukraine, [29]Emergency Hospital of Bucharest, Romania, [30]University Hospital Saint Anna, Sofia, Bulgaria, [31]Dr Peter Drzai Hospital, Ljubljana, Slovenia, [32]University Hospital Center Zagreb, Croatia, [33]Clinic for Internal Medicine InterMedic, Nis, Serbia, [34]Cardiology Department, Asklepeion General Hospital, Athens, Greece, [35]Nicosia General Hospital, Nicosia, Cyprus, [36]Istanbul University Cerrahpas?a School of Medicine, Istanbul, Turkey, [37]Hasharon Hospital – Rabin Medical Center, Petach-Tikva, Israel, [38]Beijing Xuanwu Hospital, [39]Second Affiliate Hospital, Beijing University, [40]Military General Hospital, China, [41]Hospital Clinic. University of Barcelona, Barcelona, Spain, [42]University of Cambridge,Cambridge [43]Oxford University Hospital NHS Trust, Oxford, United Kingdom

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关键词： blood pressure cognitive decline low-density lipoprotein cholesterol randomized controlled trial secondary prevention stroke

摘要：

Background and objectives: 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. Protocol design: The European Society of Hypertension-Chinese Hypertension League Stroke in Hypertension Optimal Treatment trial is a prospective multinational, randomized trial with a 3 x 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. Outcomes: 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. Sample size calculation: 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.

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出版当年[2013]版：

大类 | 2 区医学

小类 | 2 区外周血管病

最新[2023]版：

大类 | 2 区医学

小类 | 3 区外周血管病

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出版当年[2012]版：

Q1 PERIPHERAL VASCULAR DISEASE

最新[2023]版：

Q1 PERIPHERAL VASCULAR DISEASE

影响因子： 3.3 最新[2023版] 4.4 最新五年平均 3.806 出版当年[2012版] 4.384 出版当年五年平均 4.021 出版前一年[2011版] 4.222 出版后一年[2013版]

第一作者：

第一作者机构： [1]Istituto Auxologico Italiano, [2]Universita` di Milano, Milan, Italy, [*1]Istituto Auxologico Italiano, Via L.Ariosto 13, 20145 Milan, Italy.

通讯作者：

通讯机构： [*1]Istituto Auxologico Italiano, Via L.Ariosto 13, 20145 Milan, Italy.

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Blood pressure and LDL-cholesterol targets for prevention of recurrent strokes and cognitive decline in the hypertensive patient: design of the European Society of Hypertension-Chinese Hypertension League Stroke in Hypertension Optimal Treatment randomized trial

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