RhPro-UK in acute ischemic stroke within 4.5 h of stroke onset trial-2 (the PROST-2 study): Rationale and design of a multicenter, prospective, randomized, open-label, blinded-endpoint, controlled phase 3 non-inferiority trial.

IF 6.3 2区 医学 Q1 CLINICAL NEUROLOGY
International Journal of Stroke Pub Date : 2024-12-01 Epub Date: 2024-08-03 DOI:10.1177/17474930241265654
Shuya Li, Hong-Qiu Gu, Baoyu Feng, Qiang Dong, Dongsheng Fan, Yun Xu, Suiqiang Zhu, Yongjun Wang
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引用次数: 0

Abstract

Background: Recombinant prourokinase (rhPro-UK) is a specific plasmin activator, which has been approved to treat acute myocardial infarction in China.

Aim: This phase 3 trial aimed to further demonstrate the efficacy and safety of rhPro-UK in patients with acute ischemic stroke (AIS) within 4.5 h of symptom onset.

Methods and design: RhPro-UK in AIS within 4.5 h of stroke onset trial-2 (PROST-2) is a multicenter, prospective randomized, open-label, blinded end-point, non-inferiority, recombinant tissue plasmin activator (rt-PA)-controlled, phase 3 trial. A total of 1552 patients who are eligible for intravenous thrombolytic therapy from 72 clinical sites will be randomly assigned to receive either rhPro-UK 35 mg (15 mg bolus + 20 mg infusion/30 min) or rt-PA 0.9 mg/kg (10% bolus + 90% infusion/1 h).

Study outcomes: The primary outcome is the proportion of patients with a modified Rankin Scale (mRS) score of 0-1 at 90 days. Secondary efficacy outcomes include the proportion of patients with mRS score of 0-2, the distribution of mRS, self-care ability in daily life on the Barthel Index at 90 days, the proportion of subjects with ⩾ 4 points decrease in National Institutes of Health Stroke Scale (NIHSS) score or NIHSS score ⩽ 1 from baseline at 24 h and 7 days after treatment. Safety outcomes are symptomatic intracranial hemorrhage (sICH) and major systematic bleeding within 7 days as well as death from all causes within 90 days.

Discussion: The results from the PROST-2 trial will comprehensively elucidate the efficacy and safety profile of rhPro-UK as a potential alternative agent for stroke thrombolysis.

Clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT05700591.

英国 RhPro 在急性缺血性脑卒中发病 4.5 小时内治疗试验-2(PROST-2 研究):一项多中心、前瞻性、随机、开放标签、盲端点、对照的第 3 期非劣效性试验的原理与设计。
研究背景重组人普鲁鲁激酶(rhPro-UK)是一种特异性纤溶酶原激活剂,在中国已被批准用于治疗急性心肌梗死。目的:本III期试验旨在进一步证明rhPro-UK在急性缺血性卒中(AIS)患者症状出现4.5小时内的疗效和安全性:RhPro-UK治疗发病4.5小时内急性缺血性脑卒中试验-2(PROST-2)是一项多中心、前瞻性、随机、开放标签、终点盲法、非劣效、重组组织纤溶酶原激活剂(rt-PA)对照的三期试验。72个临床站点的1552名符合静脉溶栓治疗条件的患者将被随机分配接受rhPro-UK 35毫克(15毫克注射+20毫克输注/30分钟)或rt-PA 0.9毫克/千克(10%注射+90%输注/1小时)治疗:主要研究结果是 90 天时改良 Rankin 量表(mRS)评分为 0-1 的患者比例。次要疗效指标包括:mRS 评分为 0-2 分的患者比例、mRS 的分布、90 天时 Barthel 指数的日常生活自理能力、治疗后 24 小时和 7 天时美国国立卫生研究院卒中量表(NIHSS)评分较基线下降≥4 分或 NIHSS 评分≤1 分的受试者比例。安全性结果为7天内出现症状性颅内出血(sICH)和重大系统性出血,以及90天内因各种原因死亡:PROST-2试验的结果将全面阐明rhPro-UK作为中风溶栓潜在替代药物的疗效和安全性:URL: http://www.clinicaltrials.gov.唯一标识符:NCT05700591。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
International Journal of Stroke
International Journal of Stroke 医学-外周血管病
CiteScore
13.90
自引率
6.00%
发文量
132
审稿时长
6-12 weeks
期刊介绍: The International Journal of Stroke is a welcome addition to the international stroke journal landscape in that it concentrates on the clinical aspects of stroke with basic science contributions in areas of clinical interest. Reviews of current topics are broadly based to encompass not only recent advances of global interest but also those which may be more important in certain regions and the journal regularly features items of news interest from all parts of the world. To facilitate the international nature of the journal, our Associate Editors from Europe, Asia, North America and South America coordinate segments of the journal.
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