Colchicine in High-risk Patients With Acute Minor-to-moderate Ischemic Stroke or Transient Ischemic Attack (CHANCE-3)

This study is a multicentre, randomized, double-blind, placebo-controlled, investigator-sponsored study that aims to investigate the efficacy of colchicine in preventing recurrent stroke in the patients with acute minor-to-moderate ischemic stroke or TIA and a hsCRP level of ≥2mg/L.

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke; TIA
• Intervention / Treatment: Drug: Colchicine; Drug: Placebo colchicine

Detailed Description

This is a multicentre, randomized, double-blind, placebo-controlled trial that aims to investigate the efficacy of colchicine in preventing recurrent stroke in the patients with acute minor-to-moderate ischemic stroke or TIA and a hsCRP level of ≥2mg/L. Patients who were eligible to the inclusion criteria and ineligible to the exclusion criteria will be randomly assigned into two groups by a 1:1 ratio. Patients in one arm will receive colchicine initiated with a dose of 1mg per day on days 1 through 3, and continuing with 0.5 mg per day on days 4 through 90, and those in the other arm will receive an equivalent placebo drug. Study visits will be performed on the day of randomization, at discharge, at day 90 and at 1 year. The primary outcome was stroke (ischemic or hemorrhagic) during 90 days of follow-up in an intention-to treat analysis.

• Study Type: Interventional
• Enrollment (Actual): 8343
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Heze, China
    • Juancheng County People's Hospital
  • Anhui
    • Fuyang, Anhui, China
      • Linquan County People's Hospital
    • Huangshan, Anhui, China
      • Huangshan City People's Hospital
    • Wuhu, Anhui, China
      • The First Affiliated Hospital of Wannan Medical College
    • Wuhu, Anhui, China
      • The First People's Hospital of Wuhu
  • Beijing
    • Beijing, Beijing, China, 100070
      • Beijing Tiantan Hospital, Capital Medical University
    • Beijing, Beijing, China
      • Beijing Shunyi Hospital
    • Beijing, Beijing, China
      • Beijing Shunyi Airport Hospital
    • Beijing, Beijing, China
      • Fuxing Hospital, Capital Medical University
    • Beijing, Beijing, China
      • The First Hospital of Fangshan District, Beijing
  • Chongqing
    • Chongqing, Chongqing, China
      • The Second Affiliated Hospital of Chongqing Medical University
    • Chongqing, Chongqing, China
      • Chongqing University Fuling Hospital
    • Chongqing, Chongqing, China
      • Chongqing Sanbo Chang 'an Hospital
    • Chongqing, Chongqing, China
      • Chongqing Tungwah Hospital
    • Chongqing, Chongqing, China
      • The First Affiliated Hospital of Chongqing Medical and Pharmaceutical College
    • Chongqing, Chongqing, China
      • Xiushan Tujia and Miao Autonomous County People's Hospital
  • Fujian
    • Ningde, Fujian, China
      • Ningde People's Hospital
    • Sanming, Fujian, China
      • The Sanming First Hospital Affiliated to Fujian Medical University
    • Xiamen, Fujian, China
      • The First Affiliated Hospital of Xiamen University
    • Xiamen, Fujian, China
      • The Second Affiliated Hospital of Xiamen Medical College
    • Xiamen, Fujian, China
      • The Third Hospital of Xiamen
  • Gansu
    • Lanzhou, Gansu, China
      • The First People's Hospital of Lanzhou City
    • Zhangye, Gansu, China
      • Zhangye People's Hospital Affiliated To Hexi University
  • Guangdong
    • Foshan, Guangdong, China
      • The First People's Hospital of Foshan
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital of Jinan University
    • Guangzhou, Guangdong, China
      • Guangdong second provincial central hospital
    • Heyuan, Guangdong, China
      • The Fifth Affiliated Hospital of Jinan University (Heyuan Shenhe People's Hospital)
    • Huizhou, Guangdong, China
      • Huizhou First Hospital
  • Guangxi
    • Baise, Guangxi, China
      • Baise City People's Hospital
    • Wuzhou, Guangxi, China
      • The People's Hospital of Cenxi City
  • Guiyang
    • Guizhou, Guiyang, China
      • Guihang Guiyang Hospital
  • Guizhou
    • Anshun, Guizhou, China
      • Puding County People's Hospital
    • Bijie, Guizhou, China
      • Zhejiang Provincial People's Hospital Bijie Hospital
    • Guiyang, Guizhou, China
      • The First People's Hospital of Guiyang
    • Guiyang, Guizhou, China
      • The Second People's Hospital of Guiyang
    • Guiyang, Guizhou, China
      • The Third People's Hospital of Guiyang
    • Kaili, Guizhou, China
      • The People's Hospital of the Qiandongnan Miao and Dong Autonomous Prefecture
    • Kaili, Guizhou, China
      • The Second Affiliated Hospital of Guizhou Medical University
    • Xingyi, Guizhou, China
      • Qianxinan Buyi and Miao Autonomous Prefecture People's Hospital
  • Hainan
    • Haikou, Hainan, China
      • The Second Affiliated Hospital of Hainan Medical University
  • Hebei
    • Baoding, Hebei, China
      • Affiliated Hospital of Hebei University
    • Baoding, Hebei, China
      • Baoding Xushui District People's Hospital
    • Baoding, Hebei, China
      • Hebei Tang County People Hospital
    • Baoding, Hebei, China
      • Shunping County Hospital
    • Baoding, Hebei, China
      • The Hospital of Anguo City
    • Baoding, Hebei, China
      • Wangdu County Hospital,Hebei Province
    • Chengde, Hebei, China
      • Affiliated Hospital of Chengde Medical University
    • Chengde, Hebei, China
      • Chengde County Hospital
    • Handan, Hebei, China
      • Guantao county central Hospital
    • Handan, Hebei, China
      • Handan First Hospital
    • Handan, Hebei, China
      • Qiu County Hospital of Traditional Chinese Medicine
    • Handan, Hebei, China
      • Qiu County People's Hospital
    • Hejian, Hebei, China
      • Hejian People's Hospital
    • Hengshui, Hebei, China
      • Hengshui People's Hospital
    • Hengshui, Hebei, China
      • The No.4 People's Hospital of Hengshui(Department of Neurology ward 1)
    • Hengshui, Hebei, China
      • The No.4 People's Hospital of Hengshui(Department of Neurology ward 2)
    • Shijiazhuang, Hebei, China
      • The Second Hospital of Hebei Medical University
    • Shijiazhuang, Hebei, China
      • Shijiazhuang Third Hospital
    • Tangshan, Hebei, China
      • Tangshan Gongren Hospital
    • Tangshan, Hebei, China
      • North China University of Science and Technology Affiliated Hospital
    • Xingtai, Hebei, China
      • Qinghe people's hospital
    • Xingtai, Hebei, China
      • Werixian People's Hospital
    • Zhangjiakou, Hebei, China
      • The First Affiliated Hospital of Hebei North University
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • The 2nd Affiliated Hospital of Harbin Medical University
    • Harbin, Heilongjiang, China
      • The First Affiliated Hospital of Harbin Medical University
    • Shuangyashan, Heilongjiang, China
      • Hongxinglong Hospital of Beidahuang Group
  • Henan
    • Anyang, Henan, China
      • The People's Hospital of Anyang City
    • Dezhou, Henan, China
      • Dengzhou Central Hospital
    • Hebi, Henan, China
      • Hebi Coal Industry (Group) Co., Ltd. General Hospital
    • Jiaozuo, Henan, China
      • Qinyang People's Hospital
    • Jiaozuo, Henan, China
      • Boai People's Hospital
    • Jiaozuo, Henan, China
      • Mengzhou Hospital of Traditional Chinese Medicine
    • Jiaozuo, Henan, China
      • Mengzhou People's Hospital(Department of Neurology ward 1)
    • Jiaozuo, Henan, China
      • Mengzhou People's Hospital(Department of Neurology ward 2)
    • Jiaozuo, Henan, China
      • Qinyang City Hospital of Traditional Chinese Medicine
    • Jiaozuo, Henan, China
      • Wuzhi County People's Hospital
    • Jiaozuo, Henan, China
      • Xiuwu County People's Hospital
    • Jiyuan, Henan, China
      • Jiyuan Hospital of Traditional Chinese Medicine
    • Kaifeng, Henan, China
      • Kaifeng Central Hospital
    • Kaifeng, Henan, China
      • Lankao County Central Hospital
    • Kaifeng, Henan, China
      • Weishi Central Hospital
    • Luoyang, Henan, China
      • Luoyang Central Hospital
    • Luoyang, Henan, China
      • Ruyang People's Hospital
    • Luoyang, Henan, China
      • The Second Affiliated Hospital of Henan University of Science and Technology
    • Luoyang, Henan, China
      • Luoning County People's Hospital
    • Luoyang, Henan, China
      • Luoyang Dongfang People's Hospital
    • Luoyang, Henan, China
      • Luoyang First People's Hospital
    • Luoyang, Henan, China
      • Luoyang Mengjin District People's Hospital
    • Luoyang, Henan, China
      • Yiyang County People'S Hospital
    • Nanyang, Henan, China
      • Nanyang Second General Hospital
    • Nanyang, Henan, China
      • Neixiang County People's Hospital
    • Nanyang, Henan, China
      • Xichuan County People's Hospital
    • Nanyang, Henan, China
      • Xixia County People's Hospital
    • Pingdingshan, Henan, China
      • Ruzhou People's Hospital
    • Pingdingshan, Henan, China
      • The Second People's Hospital of Pingdingshan
    • Pingdingshan, Henan, China
      • Ye County People's Hospital
    • Puyang, Henan, China
      • Fanxian People's Hospital
    • Puyang, Henan, China
      • Puyang County People's Hospital
    • Puyang, Henan, China
      • Qingfeng xinxing hospital
    • Sanmenxia, Henan, China
      • The First People Hospital of Lingbao
    • Shangqiu, Henan, China
      • Sui county traditional Chinese medicine hospital
    • Shangqiu, Henan, China
      • The Fourth People's Hospital of Shangqiu
    • Shangqiu, Henan, China
      • The Shangqiu First People's Hospital
    • Shangqiu, Henan, China
      • Zhecheng People's Hospital
    • Xinxiang, Henan, China
      • Huixian People's Hospital
    • Xinxiang, Henan, China
      • The second People Hospital of Xinxiang Henan
    • Xinxiang, Henan, China
      • Xinxiang tongmeng hospital
    • Xinyang, Henan, China
      • The Affiliated Hospital of Xinyang Vocational and Technical College
    • Yongcheng, Henan, China
      • Central Hospital of Yongcheng
    • Zhengzhou, Henan, China
      • Xingyang People's Hospital
    • Zhengzhou, Henan, China
      • Xinmi Hospital of T.C.M
    • Zhoukou, Henan, China
      • Xihua Xian People's Hospital
    • Zhoukou, Henan, China
      • Shenqiu County People's Hospital
    • Zhoukou, Henan, China
      • Taikang Xian People's Hospital
    • Zhumadian, Henan, China
      • Zhumadian TCM Hospital
  • Hunan
    • Chenzhou, Hunan, China
      • Chenzhou No.1 people's Hospital
    • Chenzhou, Hunan, China
      • The Fourth People's Hospital of Chenzhou
    • Chenzhou, Hunan, China
      • The Third People's Hospital of Chenzhou
    • Hengyang, Hunan, China
      • Hengyang Central Hospital
    • Shaoyang, Hunan, China
      • Shaodong People's Hospital
    • Yueyang, Hunan, China
      • YueYang People's Hospital
  • Inner Mongolia
    • Baotou, Inner Mongolia, China
      • Sinopharm North Hospital
    • Baotou, Inner Mongolia, China
      • Baotou City Central Hospital
    • Baotou, Inner Mongolia, China
      • The First Affiliated Hospital of Baotou Medical College
    • Bayan Nur, Inner Mongolia, China
      • The people's Hospital of Wulateqianqi
    • Bayan Nur, Inner Mongolia, China
      • Wuyuan County People's Hospital
    • Hohhot, Inner Mongolia, China
      • Inner Mongolia People's Hospital
    • Hohhot, Inner Mongolia, China
      • Inner Mongolia International Mongolian Hospital
    • Hohhot, Inner Mongolia, China
      • Huhhot First Hospital
    • Hulunbuir, Inner Mongolia, China
      • Inner Mongolia Forestry General Hospital
    • Ordos, Inner Mongolia, China
      • Ordos Central Hospital
    • Tongliao, Inner Mongolia, China
      • Affiliated Hospital of Inner Mongolia Minzu University
    • Tongliao, Inner Mongolia, China
      • Tongliao City Hospital
    • Ulanqab, Inner Mongolia, China
      • Ulanpab Central Hospital
    • Wuhai, Inner Mongolia, China
      • The people's Hospital of Wuhai
  • Inner Mongoria
    • Hohhot, Inner Mongoria, China
      • Tuoketuo County Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Nanjing Gaochun People's Hospital
    • Nantong, Jiangsu, China
      • Jiangsu Rudong County People's Hospital
    • Nantong, Jiangsu, China
      • Nantong Tongzhou District No.8 People's Hospital
    • Nantong, Jiangsu, China
      • Suxitong Science and Technology Industrial Park People's Hospital
    • Nantong, Jiangsu, China
      • The People's Hospital of Rugao
    • Nantong, Jiangsu, China
      • The Sixth People's Hospital of Nantong
    • Suqian, Jiangsu, China
      • Nanjing Drum Tower Hospital Group Suqian Hospital
    • Suqian, Jiangsu, China
      • Siyang Kangda Hospital
    • Taizhou, Jiangsu, China
      • Xinghua City People's Hospital
    • Wuxi, Jiangsu, China
      • Jiangyin People's Hospital
    • Wuxi, Jiangsu, China
      • Yixing People'S Hospital
    • Xuzhou, Jiangsu, China
      • The Second Affiliated Hospital Of Xuzhou Medical University
  • Jiangxi
    • Fuzhou, Jiangxi, China
      • Fuzhou First People's Hospital of Jiangxi Province
    • Ganzhou, Jiangxi, China
      • Nanfang Hospital，Ganzhou
    • Jingdezhen, Jiangxi, China
      • Jingdezhen No.1 People's Hospital
    • Jiujiang, Jiangxi, China
      • Jiujiang University Affiliated Hospital
    • Jiujiang, Jiangxi, China
      • Jiujiang No.1 People's Hospital
    • Nanchang, Jiangxi, China
      • Jiangxi Provincial People's Hospital
    • Shangrao, Jiangxi, China
      • Shangrao People's Hospital
    • Shangrao, Jiangxi, China
      • Yugan Xinjiang hospital
    • Yichun, Jiangxi, China
      • Yichun People's Hospital
    • Yichun, Jiangxi, China
      • Tonggu County People's Hospital
  • Jilin
    • Changchun, Jilin, China
      • China-Japan Union Hospital of Jilin University
    • Meihekou, Jilin, China
      • Meihekou Central Hospital
    • Siping, Jilin, China
      • Siping Central People's Hospital
  • Liaoning
    • Anshan, Liaoning, China
      • Anshan Central Hospital
    • Dalian, Liaoning, China
      • Affiliated Zhongshan Hospital of Dalian University
    • Dalian, Liaoning, China
      • Dalian Municipal Central Hospital
    • Dalian, Liaoning, China
      • Central Hospital of Wafangdian
    • Dalian, Liaoning, China
      • Central Hospital of Zhuanghe City
    • Dalian, Liaoning, China
      • Dalian Jinzhou District First People's Hospital
    • Dalian, Liaoning, China
      • Dalian Lvshun District Hospitai of tradition Chinese Medicine
    • Dalian, Liaoning, China
      • Dalian Lvshun district people's hospital
    • Dalian, Liaoning, China
      • Dalian PuLanDian central hospital
    • Dalian, Liaoning, China
      • Dalian University Affiliated Xinhua Hospital
    • Huludao, Liaoning, China
      • The Second People's Hospital of Huludao
    • Panjin, Liaoning, China
      • Panjin Central Hospital
    • Shenyang, Liaoning, China
      • Shengjing Hospital Of China Medical University
    • Shenyang, Liaoning, China
      • The People's Hospital of Liaoning Province
    • Shenyang, Liaoning, China
      • Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
  • Ningxia
    • Guyuan, Ningxia, China
      • Guyuan People's Hospital
    • Zhongwei, Ningxia, China
      • People's Hospital of Zhongwei
  • Shaanxi
    • Ankang, Shaanxi, China
      • Ankang Central Hospital
    • Xi'an, Shaanxi, China
      • East District of The First Affiliated Hospital of Xi'an Jiaotong University
    • Xi'an, Shaanxi, China
      • Xi 'an Fengcheng Hospital
    • Xianyang, Shaanxi, China
      • Xianyang Hospital of Yan 'an University
    • Yanan, Shaanxi, China
      • Zichang People's Hospital
  • Shandogn
    • Weihai, Shandogn, China
      • Weihai Wendeng District People's Hospital
  • Shandong
    • Binzhou, Shandong, China
      • Binzhou Central Hospital
    • Binzhou, Shandong, China
      • Yangxin County People Hospital
    • Dezhou, Shandong, China
      • Ningjin People's Hospital
    • Dezhou, Shandong, China
      • People's Hospital of Qihe County
    • Dongying, Shandong, China
      • The Second People's Hospital of Dongying
    • Heze, Shandong, China
      • Yuncheng County People's Hospital
    • Jinan, Shandong, China
      • Affiliated Hospital of Shandong University of Traditional Chinese Medicine
    • Liaocheng, Shandong, China
      • Liaocheng People's Hospital
    • Liaocheng, Shandong, China
      • The Second People's Hospital of Liaocheng
    • Liaocheng, Shandong, China
      • Guanxian People's Hospital
    • Liaocheng, Shandong, China
      • Liaocheng City Central Hospital
    • Liaocheng, Shandong, China
      • Liaocheng People's Hospital（Liaocheng Brain Hospital）
    • Liaocheng, Shandong, China
      • The People's Hospital of Gaotang
    • Liaocheng, Shandong, China
      • The people's Hospital of Linqing
    • Liaocheng, Shandong, China
      • Third People's Hospital of Liaocheng
    • Liaocheng, Shandong, China
      • Yanggu Traditional Chinese Medical Hospital
    • Linyi, Shandong, China
      • Linyi People's Hospital
    • Linyi, Shandong, China
      • Linyi Central Hospital
    • Linyi, Shandong, China
      • Linyi Third People's Hospital
    • Linyi, Shandong, China
      • Linyi Traditional Chinese Medicine Hospital
    • Linyi, Shandong, China
      • People's Hospital of Yinan
    • Qingdao, Shandong, China
      • Qingdao Fuwai Cardiovascular Hospital
    • Qixian, Shandong, China
      • Qixia City People's Hospital
    • Weihai, Shandong, China
      • Weihai Central Hospital
    • Weihai, Shandong, China
      • Weihai Municipal Hospital
    • Yantai, Shandong, China
      • Yantai Yuhuangding Hospital
    • Yantai, Shandong, China
      • Qixia traditional Chinese medicine hospital
    • Yantai, Shandong, China
      • Yantai Affiliated Hospital of Binzhou Medical University
    • Yantai, Shandong, China
      • Yantai Penglai People's Hospital
    • Yantai, Shandong, China
      • Yantai Penglai traditional Chinese medicine hospital
    • Yantai, Shandong, China
      • Yantai Taocun Central Hospital
    • Yantai, Shandong, China
      • Yantai Zhifu hospital
    • Yantai, Shandong, China
      • YEDA hospital
    • Zaozhuang, Shandong, China
      • Yicheng Municipal Hospital of Zaozhuang
    • Zibo, Shandong, China
      • Zibo Central Hospital
    • Zibo, Shandong, China
      • Zibo Municipal Hospital
    • Zibo, Shandong, China
      • PKUcare Zibo Hospital
    • Zibo, Shandong, China
      • Zibo Hospital of Traditional Chinese Medicine
  • Shanghai
    • Shanghai, Shanghai, China
      • Shanghai Seventh People's Hospital
    • Shanghai, Shanghai, China
      • Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine
  • Shanxi
    • Linfen, Shanxi, China
      • Linfen Central Hospital (neurology department)
    • Linfen, Shanxi, China
      • Linfen Central Hospital(emergency department)
    • Taiyuan, Shanxi, China
      • Shanxi Bethune Hospital
    • Taiyuan, Shanxi, China
      • Second Hospital of Shanxi Medical University
    • Taiyuan, Shanxi, China
      • Shanxi Cardiovascular Hospital
  • Sichuan
    • Chengdu, Sichuan, China
      • Sichuan Provincial People's Hospital
    • Chengdu, Sichuan, China
      • The First People's Hospital of Longquanyi Disdrict,Chengdu
    • Deyang, Sichuan, China
      • People's Hospital of Deyang City
    • Mianyang, Sichuan, China
      • The Third Hospital of Mianyang
    • Neijiang, Sichuan, China
      • The Second People's Hospital of Neijiang
    • Panzhihua, Sichuan, China
      • Panzhihua Central Hospital
  • Xinjiang
    • Shihezi, Xinjiang, China
      • The First Affiliated Hospital of Shihezi University
    • Urumqi, Xinjiang, China
      • People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China
  • Yunnan
    • Kunming, Yunnan, China
      • First Affiliated Hospital of Kunming Medical University
    • Nujiang, Yunnan, China
      • Yunnan Nujiang Lisu Autonomous Prefecture People's Hospital
    • Pu'er, Yunnan, China
      • Ninger County People's Hospital
    • Tengchong, Yunnan, China
      • Tengchong People's Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • The First People's Hospital of jiande
    • Huzhou, Zhejiang, China
      • People's Hospital of Anji
    • Jiaxing, Zhejiang, China
      • Haiyan People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 40 years or older than 40 years；
2. Acute cerebral ischemic event due to： Acute minor-to-moderate ischemic stroke (NIHSS≤5 at the time of randomization) or TIA with moderate-to-high risk of stroke (ABCD2 score ≥ 4 at the time of randomization)；
3. With a hsCRP level of ≥2mg/L at randomization;
4. Can be treated with study drug within 24 hours of symptoms onset*(*Symptom onset is defined by the "last seen normal" principle)；
5. Informed consent signed.

Exclusion Criteria:

1. Malformation, tumor, abscess or other major non-ischemic brain disease (e.g., multiple sclerosis) on baseline head CT or MRI.
2. Isolated or pure sensory symptoms (e.g., numbness), isolated visual changes, or isolated dizziness/vertigo without evidence of acute infarction on baseline head CT or MRI.
3. Iatrogenic causes (angioplasty or surgery) of stroke or TIA.
4. Presumed cardiac source of embolus, such as atrial fibrillation or prosthetic cardiac valve).
5. A score of ≥ 2 on the modified Rankin scale immediately before the occurrence of the index event.
6. Usage of colchicine within 30 days before randomization or planning to take colchicine therapy for other indications.
7. Known allergy or sensitivity or intolerance to colchicine.
8. Inflammatory bowel disease (Crohn's or ulcerative colitis) or chronic diarrhea.
9. Symptomatic peripheral neuropathy or pre-existing progressive neuromuscular disease or with creatine kinase (CK) level > 3 times the upper limit of normal as measured within the past 30 days and determined to be non-transient through repeat testing.
10. A history of cirrhosis, chronic active hepatitis or severe hepatic disease.
11. Impaired hepatic (ALT or AST > twice the upper limit of normal range) or kidney (creatinine exceeding 1.5 times of the upper limit of normal range or eGFR less than 50 ml/min) function at randomization.
12. Anemia (haemoglobin <10g/dL), thrombocytopenia (platelet count <100×109/L) or leucopenia (white blood cell <3×109/L) at randomization.
13. In the acute phase of respiratory tract infection, urinary tract infection, and gastro-enteritis, or currently using or planning to receive oral or intravenous anti-infective therapy for any other infection.
14. Currently using or planning to begin long-term (>7 days) systemic anti-inflammatory drugs (NSAIDs except for aspirin, oral or intravenous steroid therapy) during the study.
15. Planning to use moderate or strong CYP3A4 inhibitors (clarithromycin, erythromycin, telithromycin, other macrolide antibiotics, ketoconazole, itraconazole, voriconazole, ritonavir, atazanavir, indinavir, other HIV protease inhibitors, verapamil, diltiazem, quinidine, digoxin, disulfiram, etc) or P-gp inhibitors (cyclosporine) at randomization.
16. Planned surgery or interventional treatment requiring cessation of the study drug during the study.
17. Participating in another clinical trial with an investigational drug or device concurrently or during the last 30 days.
18. Women of childbearing age who were not practicing reliable contraception and did not have a documented negative pregnancy test or severe noncardiovascular coexisting condition.
19. Severe non-cardiovascular comorbidity with a life expectancy of less than 3 months.
20. With a history of clinically significant drug or alcohol abuse.
21. Inability to understand and/or follow research procedures due to mental, cognitive, or emotional disorders, or to be an unsuitable candidate for the study for any other considered by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Colchicine Group; Patients in this arm will receive colchicine for 90 days in addition to standard medical care	Drug: Colchicine; Oral colchicine will be initiated with a dose of 1mg per day (one tablet of 0.5mg initially followed by another tablet of 0.5 mg at least four hours later) on days 1 through 3, and continuing with 0.5 mg (one tablet) per day on days 4 through 90.
Placebo Comparator: Placebo Colchicine Group; Patients in this arm will receive placebo colchicine for 90 days in addition to standard medical care	Drug: Placebo colchicine; Oral placebo colchicine will be initiated with a dose of 1mg per day (one tablet of 0.5mg initially followed by another tablet of 0.5 mg at least four hours later) on days 1 through 3, and continuing with 0.5 mg (one tablet) per day on days 4 through 90.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Any new stroke events	Incidence of any new ischemic or hemorrhagic stroke	any time within 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New vascular events	Incidence of any new vascular events, including ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction and vascular death	any time within 90 days
New ischemic stroke	Incidence of any new ischemic stroke	any time within 90 days
Poor functional outcome	Rate of poor functional outcome defined as a Modified Rankin Scale score of >1 (Modified Rankin Scale score ranges from 0 (no symptoms) to 6 (death) and higher score means worse outcome)	at 90 days after randomization
New stroke and TIA	Incidence of any new stroke and TIA	any time within 90 days
Severity of recurrent stroke and TIA	Severity is measured using a six-level ordered categorical scale that incorporates the mRS: fatal stroke [mRS 6]/severe non-fatal stroke [mRS 4 or 5]/moderate stroke [mRS 2 or 3]/mild stroke [mRS 0 or 1]/TIA/no stroke-TIA	within 90 days after randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Any new stroke events	Incidence of any new ischemic or hemorrhagic stroke	any time within 1 year after randomization
New vascular events	Incidence of any new vascular events, including ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction and vascular death	any time within 1 year after randomization
New ischemic stroke	Incidence of any new ischemic stroke	any time within 1 year after randomization
Poor functional outcome	Rate of poor functional outcome defined as a Modified Rankin Scale score of >1 (Modified Rankin Scale score ranges from 0 (no symptoms) to 6 (death) and higher score means worse outcome)	at 1 year after randomization
New stroke and TIA	Incidence of any new stroke and TIA	any time within 1 year after randomization
Severity of recurrent stroke and TIA	Severity is measured using a six-level ordered categorical scale that incorporates the mRS: fatal stroke [mRS 6]/severe non-fatal stroke [mRS 4 or 5]/moderate stroke [mRS 2 or 3]/mild stroke [mRS 0 or 1]/TIA/no stroke-TIA	within 1 year after randomization
Adverse events	Rate of adverse events ( AEs )	within 90 days
Severe adverse events	Rate of serious adverse events ( SAEs )	within 90 days
Increased CK levels or abnormal hepatic function when concomitant high-intensity statin treatment	Rate of increased CK levels (≥ 5 times the upper limit of normal) or abnormal hepatic function (ALT or AST ≥ 3 times the upper limit of normal range) within 90 days when concomitant high-intensity statin treatment	within 90 days
Adverse events	Rate of adverse events ( AEs )	within 1 year
Severe adverse events	Rate of serious adverse events ( SAEs )	within 1 year

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2022
• Primary Completion (Actual): July 13, 2023
• Study Completion (Actual): April 12, 2024

Study Registration Dates

• First Submitted: June 20, 2022
• First Submitted That Met QC Criteria: June 29, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Actual): June 25, 2024
• Last Update Submitted That Met QC Criteria: June 24, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Ischemic Attack, Transient; Cerebral Infarction; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Gout Suppressants; Colchicine
• Other Study ID Numbers: NCRC-2022-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data collected for the study can be made available to other researchers on reasonable request and after signing appropriate data sharing agreements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No