Rationale: Very early stage blood pressure (BP) levels may affect outcome in stroke patients who have successfully undergone recanalization following intra-arterial treatment (IAT), but the optimal target of BP management remains uncertain.

Aim: We hypothesized that the clinical outcome after intensive BP-lowering is superior to conventional BP-lowering after successful recanalization by IAT.

Sample-size estimates: We aim to randomize 668 patients (334 per arm), 1:1.

Methods and design: We initiated a multicenter, prospective, randomized, open-label trial with a blinded end-point assessment (PROBE) design. After successful recanalization (thrombolysis in cerebral infarction score ≥ 2b), patients with elevated systolic BP level, defined as the mean of two readings ≥ 140 mmHg, will be randomly assigned to the intensive BP-lowering (systolic BP < 140 mm Hg) group or the conventional BP (systolic BP, 140−180 mm Hg) group.

Study outcomes: The primary efficacy outcomes are from dichotomized analysis of modified Rankin Scale (mRS) scores at 3 months (mRS scores: 0–2 vs. 3–6) and from a shift analysis. A shift in functioning measures according to the full range of mRS scores will be analyzed. The primary safety outcomes are symptomatic intracerebral hemorrhage and death within 3 months.

Discussion: The OPTIMAL-BP trial will provide evidence for the effectiveness of active BP control to achieve systolic BP < 140 mmHg during 24 h in patients with successful recanalization after IAT.

理由：非常早期的血压 (BP) 水平可能会影响动脉内治疗 (IAT) 后成功接受再通的卒中患者的结果，但血压管理的最佳目标仍不确定。

目的：我们假设强化降压后的临床结果优于 IAT 成功再通后的常规降压。

样本量估计：我们的目标是随机分配 668 名患者（每组 334 名），比例为 1:1。

方法和设计：我们启动了一项采用盲法终点评估 (PROBE) 设计的多中心、前瞻性、随机、开放标签试验。成功再通后（脑梗塞溶栓评分≥2b），收缩压升高的患者，定义为两个读数的平均值≤140 mmHg，将被随机分配到强化BP-降低（收缩压<140 毫米汞柱）组或常规血压（收缩压，140 ～ 180 毫米汞柱）组。

研究结果：主要疗效结果来自对 3 个月时修正的 Rankin 量表 (mRS) 评分的二分分析（mRS 评分：0～2 对 3～6）和移位分析。将分析根据 mRS 分数的全部范围的功能测量的变化。主要安全性结局是症状性脑出血和 3 个月内死亡。

讨论：OPTIMAL-BP 试验将为 IAT 后成功再通的患者在 24 小时内实现收缩压 < 140 mmHg 的有效血压控制提供证据。