Colchicine for the Prevention of Vascular Events After an Acute Intracerebral Hemorrhage: A Placebo-Controlled Trial.

IF 11.1 1区医学 Q1 CLINICAL NEUROLOGY

Stroke Pub Date : 2026-10-01 Epub Date: 2026-08-06 DOI:10.1161/STROKEAHA.126.055934

Aristeidis H Katsanos, Kelvin K H Ng, Thalia S Field, Aravind Ganesh, Joanna D Schaafsma, Shirin Jalini, Ashfaq Shuaib, Lauren M Mai, Amy Y X Yu, Laura C Gioia, Regan Cooley, Dar Dowlatshahi, Abhilekh Srivastava, Georgios Tsivgoulis, Angela Wang, Kumar Balasubramanian, Kevin W Reeh, Amanda Taylor, Robert G Hart, Ashkan Shoamanesh

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引用次数: 0

Abstract

Background: There is a need for novel treatments that lower the risk of major adverse cardiovascular events and secondary inflammatory brain injury after an intracerebral hemorrhage (ICH).

Methods: We performed a double-blind, placebo-controlled, pilot randomized clinical trial at 11 centers across Canada to determine the feasibility of testing colchicine after an acute ICH. We recruited adults presenting within 48 hours of ICH onset with vascular neuroimaging evidence or risk factors for atherosclerosis. Participants were randomized to oral colchicine 0.5 mg daily or placebo and followed to a common study termination date. The primary feasibility outcome was the recruitment rate (participants/center per year). Secondary feasibility outcomes included retention of participants at 6 months and medication adherence at 12 months. This trial is registered (URL: https://www.clinicaltrials.gov; Unique identifier: NCT05159219).

Results: Between August 2022 and March 2024, 52 participants were allocated to colchicine 0.5 mg daily and 48 participants to placebo daily. Participants were, on average, 68 years old, and 60% were male. The mean time from ICH onset to randomization was 35 hours. The average recruitment rate was 8.9 participants/site per year. Retention at 6 months was 92% (colchicine 91% versus placebo 93%). Following randomization, 14 participants (27%) in the colchicine group and 13 participants (27%) in the placebo group permanently discontinued the study drug. Excluding participants who died or permanently discontinued the study intervention, 12-month medication adherence was 97%, with similar rates between the colchicine and placebo groups (100% versus 93%). We detected no difference in predefined exploratory efficacy or safety end points between the 2 groups over the median follow-up time of 364 days.

Conclusions: It is feasible to test low-dose colchicine after an acute ICH. Future randomized clinical trials should account for the high rates of early permanent study drug discontinuation in this patient population.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05159219.

查看原文本刊更多论文

秋水仙碱预防急性脑出血后血管事件：一项安慰剂对照试验。

背景：需要新的治疗方法来降低脑出血（ICH）后主要不良心血管事件和继发性炎症性脑损伤的风险。方法：我们在加拿大的11个中心进行了一项双盲、安慰剂对照、先导随机临床试验，以确定在急性脑出血后检测秋水仙碱的可行性。我们招募了在脑出血发病48小时内有血管神经影像学证据或动脉粥样硬化危险因素的成年人。参与者随机分为每日口服秋水仙碱0.5 mg组或安慰剂组，随访至共同研究终止日期。主要可行性结果是招募率（参与者/中心每年）。次要可行性结果包括参与者在6个月时的保留率和12个月时的药物依从性。本试验已注册（ClinicalTrials.gov ID: REGISTRATION: URL: https://www.clinicaltrials.gov；唯一标识符：NCT05159219）。结果：在2022年8月至2024年3月期间，52名参与者每天服用0.5 mg秋水仙碱，48名参与者每天服用安慰剂。参与者的平均年龄为68岁，其中60%为男性。从脑出血发病到随机分组的平均时间为35小时。平均招聘率为每年8.9名参与者/站点。6个月的保留率为92%（秋水仙碱91% vs安慰剂93%）。随机分组后，秋水仙碱组14名参与者（27%）和安慰剂组13名参与者（27%）永久停用研究药物。排除死亡或永久停止研究干预的参与者，12个月的药物依从性为97%，秋水仙碱组和安慰剂组的依从性相似（100%对93%）。在364天的中位随访时间内，我们发现两组之间预定义的探索性疗效或安全性终点没有差异。结论：在急性脑出血后进行低剂量秋水仙碱试验是可行的。未来的随机临床试验应该考虑到该患者群体中早期永久性停药的高发生率。注册：网址：https://www.clinicaltrials.gov；唯一标识符：NCT05159219。

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

Stroke 医学-临床神经学

CiteScore

13.40

自引率

6.00%

发文量

2021

审稿时长

3 months

期刊介绍： Stroke is a monthly publication that collates reports of clinical and basic investigation of any aspect of the cerebral circulation and its diseases. The publication covers a wide range of disciplines including anesthesiology, critical care medicine, epidemiology, internal medicine, neurology, neuro-ophthalmology, neuropathology, neuropsychology, neurosurgery, nuclear medicine, nursing, radiology, rehabilitation, speech pathology, vascular physiology, and vascular surgery. The audience of Stroke includes neurologists, basic scientists, cardiologists, vascular surgeons, internists, interventionalists, neurosurgeons, nurses, and physiatrists. Stroke is indexed in Biological Abstracts, BIOSIS, CAB Abstracts, Chemical Abstracts, CINAHL, Current Contents, Embase, MEDLINE, and Science Citation Index Expanded.