Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH) II: design, methods, and rationale.
Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH) II: design, methods, and rationale.
复制标题
DOI：
10.1007/s12028-011-9538-3
复制
发表时间：
2011-12
影响因子：
3.5
通讯作者：
Palesch YY
中科院分区：
文献类型：
--
作者：
Qureshi AI;Palesch YY
2003年12月，国家神经疾病和卒中研究所（NINDS）关于脑出血（ICH）临床研究优先事项的研讨会报告建议将评价急性ICH血压管理的临床试验作为优先事项。1999年和2007年，美国心脏协会卒中理事会特别写作小组强调需要进行临床试验，以确保ICH急性高血压反应的循证治疗。为了解决知识上的重要空白，我们在2004-2008年期间进行了一项由NINDS资助的试点研究，即急性脑出血的抗高血压治疗（ATACH）I试验，以确定收缩压（SBP）降低的适当水平。我们现在已经启动了一项多中心、随机III期试验，即ATACH II试验，以明确确定在自发性幕上ICH受试者中，在ICH发作后3小时内开始静脉（IV）尼卡地平早期强化降压治疗并持续24小时的疗效。这项大型（N = 1，280）、简化和集中试验的主要假设是，与标准SBP降至≤180 mm Hg相比，SBP降至≤140 mm Hg可将ICH后3个月时死亡或残疾的可能性（定义为改良兰金量表评分4-6分）绝对降低至少10%。ATACH II试验是众多病例系列的自然延伸，随后的ATACH I试点试验，以及由澳大利亚国家健康和医学研究理事会资助的在该患者人群中进行的初步、随机和对照试验。这两项试验最近证实了本试验中提出的急性高血压ICH患者降压治疗方案和目标的安全性和耐受性。强化治疗的预期有益作用的潜在机制可能是通过降低在约73%的急性ICH患者中观察到的血肿扩张的速率和幅度介导的。澳大利亚试验提供了血肿扩张减弱和SBP强化降低的初步证据。ATACH II试验通过提供ICH受试者中急性降压治疗的疗效和安全性的证据或缺乏证据，将具有重要的公共卫生意义。这种治疗代表了一种无需专门设备和人员即可广泛使用的策略，因此可以对ICH患者治疗的临床实践产生重大影响。
The December 2003 report from the National Institute of Neurological Disorders and Stroke (NINDS) Workshop on priorities for clinical research in intracerebral hemorrhage (ICH) recommended clinical trials for evaluation of blood pressure management in acute ICH as a leading priority. The Special Writing Group of the Stroke Council of the American Heart Association in 1999 and 2007 emphasized the need for clinical trials to ensure evidence-based treatment of acute hypertensive response in ICH. To address important gaps in knowledge, we conducted a pilot study funded by the NINDS, Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH) I Trial, during 2004–2008 to determine the appropriate level of systolic blood pressure (SBP) reduction. We now have initiated a multicenter, randomized Phase III trial, the ATACH II Trial, to definitively determine the efficacy of early, intensive, anti-hypertensive treatment using intravenous (IV) nicardipine initiated within 3 h of onset of ICH and continued for the next 24 h in subjects with spontaneous supratentorial ICH. The primary hypothesis of this large (N = 1,280), streamlined, and focused trial is that SBP reduction to ≤140 mm Hg reduces the likelihood of death or disability at 3 months after ICH, defined by modified Rankin scale score of 4–6, by at least 10% absolute compared to standard SBP reduction to ≤180 mm Hg. The ATACH II trial is a natural extension of numerous case series, the subsequent ATACH I pilot trial, and a preliminary, randomized, and controlled trial in this patient population funded by the Australian National Health and Medical Research Council. Both trials recently confirmed the safety and tolerability of both the regimen and goals of antihypertensive treatment in acutely hypertensive patients with ICH, as proposed in the present trial. The underlying mechanism for this expected beneficial effect of intensive treatment is presumably mediated through reduction of the rate and magnitude of hematoma expansion observed in approximately 73% of the patients with acute ICH. The Australian trial provided preliminary evidence of attenuation of hematoma expansion with intensive SBP reduction. The ATACH II trial will have important public health implications by providing evidence of, or lack thereof, regarding the efficacy and safety of acute antihypertensive treatment in subjects with ICH. This treatment represents a strategy that can be made widely available without the need for specialized equipment and personnel, and therefore, can make a major impact upon clinical practice for treating patients with ICH.
登录
查看更多内容
影响因子：
8.3
作者：
Hemphill, JC;Bonovich, DC;Johnston, SC
通讯作者：
Johnston, SC
影响因子：
8.3
作者：
Adams, Harold P., Jr.;Effron, Mark B.;Hacke, Werner
通讯作者：
Hacke, Werner
影响因子：
8.3
作者：
Flaherty, ML;Woo, D;Broderick, JP
通讯作者：
Broderick, JP
影响因子：
--
作者：
Day, SJ;Altman, DG
通讯作者：
Altman, DG
影响因子：
8.3
作者：
ADAMS, HP
通讯作者：
ADAMS, HP