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Colchicine in patients with acute ischaemic stroke or transient ischaemic attack (CHANCE-3): multicentre, double blind, randomised, placebo controlled trial.
Li, Jiejie; Meng, Xia; Shi, Fu-Dong; Jing, Jing; Gu, Hong-Qiu; Jin, Aoming; Jiang, Yong; Li, Hao; Johnston, S Claiborne; Hankey, Graeme J; Easton, J Donald; Chang, Liguo; Shi, Penglai; Wang, Lihua; Zhuang, Xianbo; Li, Haitao; Zang, Yingzhuo; Zhang, Jianling; Sun, Zengqiang; Liu, Dongqi; Li, Ying; Yang, Hongqin; Zhao, Jinguo; Yu, Weiran; Wang, Anxin; Pan, Yuesong; Lin, Jinxi; Xie, Xuewei; Jin, Wei-Na; Li, Shuya; Niu, Siying; Wang, Yilong; Zhao, Xingquan; Li, Zixiao; Liu, Liping; Zheng, Huaguang; Wang, Yongjun.
Afiliación
  • Li J; Department of Neurology and China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
  • Meng X; Department of Neurology and China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
  • Shi FD; Department of Neurology and China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
  • Jing J; Department of Neurology and China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
  • Gu HQ; Department of Neurology and China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
  • Jin A; Department of Neurology and China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
  • Jiang Y; Department of Neurology and China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
  • Li H; Department of Neurology and China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
  • Johnston SC; Department of Neurology, University of California, San Francisco, CA, USA.
  • Hankey GJ; Medical School, University of Western Australia, Perth, WA, Australia.
  • Easton JD; Perron Institute for Neurological and Translational Science, Perth, WA, Australia.
  • Chang L; Department of Neurology, University of California, San Francisco, CA, USA.
  • Shi P; Department of Neurology, Liaocheng Third People's Hospital, Shandong, China.
  • Wang L; Department of Neurology, Yantai Penglai Traditional Chinese Medicine Hospital, Shandong, China.
  • Zhuang X; Department of Neurology, The Second Affiliated Hospital of Harbin Medical University, Heilongjiang, China yongjunwang@ncrcnd.org.cn.
  • Li H; Department of Neurology, Liaocheng People's Hospital, Shandong, China.
  • Zang Y; Department of Neurology, The People's Hospital of Qihe County, Shandong, China.
  • Zhang J; Department of Neurology, Qinghe People's Hospital, Hebei, China.
  • Sun Z; Department of Neurology, The Fourth People's Hospital of Hengshui, Hebei, China.
  • Liu D; Department of Neurology, Zibo Municipal Hospital, Shandong, China.
  • Li Y; Department of Neurology, Hejian People's Hospital, Hebei, China.
  • Yang H; Department of Neurology, Suixian Chinese Medicine Hospital, Henan, China.
  • Zhao J; Department of Neurology, Jiyuan Hospital of TCM, Henan, China.
  • Yu W; Department of Neurology, Weihai Wendeng District People's Hospital, Shandong, China.
  • Wang A; Department of Neurology and China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
  • Pan Y; Department of Neurology and China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China yongjunwang@ncrcnd.org.cn.
  • Lin J; Department of Neurology and China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
  • Xie X; Department of Neurology and China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
  • Jin WN; Department of Neurology and China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
  • Li S; Department of Neurology and China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
  • Niu S; Department of Neurology and China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
  • Wang Y; Department of Neurology and China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
  • Zhao X; Department of Neurology and China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China yongjunwang@ncrcnd.org.cn.
  • Li Z; Department of Neurology and China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
  • Liu L; Department of Neurology and China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
  • Zheng H; Department of Neurology and China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
  • Wang Y; Department of Neurology and China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
BMJ ; 385: e079061, 2024 06 26.
Article en En | MEDLINE | ID: mdl-38925803
ABSTRACT

OBJECTIVES:

To assess the efficacy and safety of colchicine versus placebo on reducing the risk of subsequent stroke after high risk non-cardioembolic ischaemic stroke or transient ischaemic attack within the first three months of symptom onset (CHANCE-3).

DESIGN:

Multicentre, double blind, randomised, placebo controlled trial.

SETTING:

244 hospitals in China between 11 August 2022 and 13 April 2023.

PARTICIPANTS:

8343 patients aged 40 years of age or older with a minor-to-moderate ischaemic stroke or transient ischaemic attack and a high sensitivity C-reactive protein ≥2 mg/L were enrolled.

INTERVENTIONS:

Patients were randomly assigned 11 within 24 h of symptom onset to receive colchicine (0.5 mg twice daily on days 1-3, followed by 0.5 mg daily thereafter) or placebo for 90 days. MAIN OUTCOME

MEASURES:

The primary efficacy outcome was any new stroke within 90 days after randomisation. The primary safety outcome was any serious adverse event during the treatment period. All efficacy and safety analyses were by intention to treat.

RESULTS:

4176 patients were assigned to the colchicine group and 4167 were assigned to the placebo group. Stroke occurred within 90 days in 264 patients (6.3%) in the colchicine group and 270 patients (6.5%) in the placebo group (hazard ratio 0.98 (95% confidence interval 0.83 to 1.16); P=0.79). Any serious adverse event was observed in 91 (2.2%) patients in the colchicine group and 88 (2.1%) in the placebo group (P=0.83).

CONCLUSIONS:

The study did not provide evidence that low-dose colchicine could reduce the risk of subsequent stroke within 90 days as compared with placebo among patients with acute non-cardioembolic minor-to-moderate ischaemic stroke or transient ischaemic attack and a high sensitivity C-reactive protein ≥2 mg/L. TRIAL REGISTRATION ClinicalTrials.gov, NCT05439356.
Asunto(s)

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Ataque Isquémico Transitorio / Colchicina / Accidente Cerebrovascular Isquémico Límite: Adult / Aged / Female / Humans / Male / Middle aged País/Región como asunto: Asia Idioma: En Revista: BMJ Asunto de la revista: MEDICINA Año: 2024 Tipo del documento: Article País de afiliación: China

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Ataque Isquémico Transitorio / Colchicina / Accidente Cerebrovascular Isquémico Límite: Adult / Aged / Female / Humans / Male / Middle aged País/Región como asunto: Asia Idioma: En Revista: BMJ Asunto de la revista: MEDICINA Año: 2024 Tipo del documento: Article País de afiliación: China