The George Institute for International Health, Royal Prince Alfred Hospital, University of Sydney, Sydney, NSW, Australia.
Int J Stroke. 2010 Apr;5(2):110-6. doi: 10.1111/j.1747-4949.2010.00415.x.
The INTERACT pilot study demonstrated the feasibility of the protocol, safety of early intensive blood pressure lowering and effects on haematoma expansion within 6 h of onset of intracerebral haemorrhage. This article describes the design of the second, main phase, INTERACT2.
To compare the effects of a management strategy of early intensive blood pressure lowering with a more conservative guideline-based blood pressure management policy in patients with acute intracerebral hemorrhage.
INTERACT2 is a prospective, randomized, open label, assessor-blinded end-point (PROBE). Patients with a systolic blood pressure greater than 150 mmHg and no definite indication for or contraindication to blood pressure-lowering treatment are centrally randomised to either of two treatment groups within 6 h onset of intracerebral haemorrhage. Those allocated to intensive blood pressure lowering will receive primarily intravenous, hypotensive agents to achieve a systolic blood pressure target of <140 mmHg within 1 h of randomisation and to maintain this level for up to 7 days in hospital. The control group will receive blood pressure-lowering treatment to a target systolic blood pressure of <180 mmHg. Both groups are to receive similar acute stroke unit care, therapy and active management. Oral antihypertensive therapy is recommended in patients before hospital discharge with a long-term systolic blood pressure goal of 140 mmHg according to secondary stroke prevention guidelines. A projected 2800 subjects are to be enrolled from approximately 140 centres worldwide to provide 90% power (alpha 0.05) to detect a 14% difference in the risk of death and dependency between the groups, which equates to one or more cases of a poor outcome prevented in every 15 patients treated.
The primary outcome is the combined end-point of death and dependency according to the modified Rankin Scale at 90 days. The secondary outcomes are the separate components of the primary end-point in patients treated <4 hours of ICH onset, grades of physical function on the modified Rankin Scale, health-related quality of life on the EuroQoL, recurrent stroke and other vascular events, days of hospitalisation, requirement for permanent residential care and unexpected serious adverse events.
INTERACT 试验的预试验阶段证实了该方案的可行性，也证实了脑出血发病后 6 小时内进行强化降压治疗的安全性和血肿扩大效应。本文描述了 INTERACT2 的第二阶段，即主要阶段的设计。
比较急性脑出血患者采用强化降压治疗策略与基于指南的更保守降压管理策略的效果。
INTERACT2 是一项前瞻性、随机、开放标签、评估者设盲终点（PROBE）试验。收缩压＞150mmHg 且无明确降压适应证或禁忌证的患者，在脑出血发病后 6 小时内通过中央随机分配至强化降压组或常规降压组。强化降压组患者主要接受静脉降压药物治疗，在随机分组后 1 小时内将收缩压目标值降至＜140mmHg，并在院内维持 7 天。对照组患者接受降压治疗，收缩压目标值＜180mmHg。两组患者均接受类似的急性卒中单元治疗、治疗和积极管理。建议在患者出院前给予口服降压药物治疗，长期收缩压目标值为 140mmHg，依据二级预防卒中指南。预计将在全球约 140 个中心招募 2800 例患者，以 90%的效能（α=0.05）检测两组间死亡率和依赖性风险差异 14%，这相当于每治疗 15 例患者可预防 1 例不良结局。
主要结局为 90 天时死亡和依赖性复合终点，改良 Rankin 量表评分。次要结局为＜4 小时脑出血发病的患者的主要结局的单独组分、改良 Rankin 量表的身体功能分级、EuroQoL 的健康相关生活质量、复发性卒中和其他血管事件、住院天数、需要永久性护理和意外严重不良事件。
