Department of neurology, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China.
Medical Research Center, State Key laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
BMJ Open. 2024 Jun 10;14(6):e082141. doi: 10.1136/bmjopen-2023-082141.
Branch atheromatous disease (BAD)-related stroke is increasingly becoming a clinical entity and prone to early neurological deterioration (END) and poor prognosis. There are no effective regimens to reduce the disability caused by BAD-related stroke in acute phase. Recent studies have indicated the efficacy of tirofiban in acute ischaemic stroke; however, its efficacy has not been validated in patients with BAD-related stroke. Thus, we aim to test whether intravenous tirofiban initiated within 48 hours after the onset would improve the functional outcome in patients with acute BAD-related stroke, in comparison with the standard antiplatelet therapy based on the current guideline.
BRANT is a multicentre, randomised, open-label, blinded endpoint, parallel-controlled, phase III trial conducted in 21 hospitals in China. Participants aged 18-75 years with acute BAD-related stroke within 48 hours after the stroke onset are randomised in a 1:1 ratio to the tirofiban or control group. The treatment period is 48 hours in both groups. The primary outcome is the excellent functional outcome (modified Rankin Scale Score: 0-1) at 90 days. The secondary outcomes include END, major bleeding, stroke, death, functional status, serious adverse events and change in bleeding-related markers. Assuming the rates of the primary outcome to be 74% in the tirofiban group and 62% in the control group, a total of 516 participants are needed for 0.8 power (two-sided 0.05 alpha).
BRANT study has been approved by the Ethics Committee of the Peking Union Medical College Hospital (I-23PJ1242). Written informed consent is required for all the patients before enrolment. The results of the study will be published in a peer-reviewed journal.
ClinicalTrials.gov (NCT06037889).
分支粥样硬化性疾病（BAD）相关的卒中越来越成为一种临床实体，易发生早期神经功能恶化（END）和预后不良。目前尚无有效的方案可减少急性期 BAD 相关卒中引起的残疾。最近的研究表明，替罗非班在急性缺血性卒中中有疗效；然而，其在 BAD 相关卒中患者中的疗效尚未得到验证。因此，我们旨在测试在发病后 48 小时内开始静脉内给予替罗非班是否会改善急性 BAD 相关卒中患者的功能结局，与基于当前指南的标准抗血小板治疗相比。
BRANT 是一项在中国 21 家医院进行的多中心、随机、开放标签、盲终点、平行对照、III 期试验。纳入年龄在 18-75 岁之间、发病后 48 小时内的急性 BAD 相关卒中患者，按 1:1 比例随机分为替罗非班组或对照组。两组的治疗期均为 48 小时。主要结局是 90 天时的良好功能结局（改良 Rankin 量表评分：0-1）。次要结局包括 END、大出血、卒中和死亡、功能状态、严重不良事件和出血相关标志物的变化。假设替罗非班组的主要结局发生率为 74%，对照组为 62%，则需要 516 例患者以达到 0.8 的功效（双侧 0.05α）。
BRANT 研究已获得北京协和医学院医院伦理委员会的批准（I-23PJ1242）。所有患者在入组前均需签署书面知情同意书。研究结果将发表在同行评议的期刊上。
ClinicalTrials.gov（NCT06037889）。
