AzTrials
AzTrials

Ischemic StrokePhase 3NCT05439356

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

A Phase 3 study testing Colchicine in people with Ischemic Stroke and TIA, run by Beijing Tiantan Hospital at 244 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Ischemic Stroke, TIA
What is being tested?
Colchicine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
8,343 participants
Where
244 sitesChina
Study dates
11 Aug 2022to 12 Apr 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 40 years or older than 40 years；
  • 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)；
  • With a hsCRP level of ≥2mg/L at randomization;
  • Can be treated with study drug within 24 hours of symptoms onset*(*Symptom onset is defined by the "last seen normal" principle)；
  • Informed consent signed.

Who cannot join

  • Malformation, tumor, abscess or other major non-ischemic brain disease (e.g., multiple sclerosis) on baseline head CT or MRI.
  • 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.
  • Iatrogenic causes (angioplasty or surgery) of stroke or TIA.
  • Presumed cardiac source of embolus, such as atrial fibrillation or prosthetic cardiac valve).
  • A score of ≥ 2 on the modified Rankin scale immediately before the occurrence of the index event.
  • Usage of colchicine within 30 days before randomization or planning to take colchicine therapy for other indications.
Show all 21Show fewer
  • Known allergy or sensitivity or intolerance to colchicine.
  • Inflammatory bowel disease (Crohn's or ulcerative colitis) or chronic diarrhea.
  • 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.
  • A history of cirrhosis, chronic active hepatitis or severe hepatic disease.
  • 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.
  • Anemia (haemoglobin <10g/dL), thrombocytopenia (platelet count <100×109/L) or leucopenia (white blood cell <3×109/L) at randomization.
  • 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.
  • 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.
  • 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.
  • Planned surgery or interventional treatment requiring cessation of the study drug during the study.
  • Participating in another clinical trial with an investigational drug or device concurrently or during the last 30 days.
  • Women of childbearing age who were not practicing reliable contraception and did not have a documented negative pregnancy test or severe noncardiovascular coexisting condition.
  • Severe non-cardiovascular comorbidity with a life expectancy of less than 3 months.
  • With a history of clinically significant drug or alcohol abuse.
  • 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.

Trial locations and contacts

244 sites in 1 country.

244 sites in 1 country

China244 sites

  • Ankang Central Hospital

    Ankang, Shaanxi

  • Anshan Central Hospital

    Anshan, Liaoning

  • Puding County People's Hospital

    Anshun, Guizhou

  • The People's Hospital of Anyang City

    Anyang, Henan

  • Baise City People's Hospital

    Baise City, Guangxi

  • Affiliated Hospital of Hebei University

    Baoding, Hebei

  • Baoding Xushui District People's Hospital

    Baoding, Hebei

  • Hebei Tang County People Hospital

    Baoding, Hebei

  • Shunping County Hospital

    Baoding, Hebei

  • The Hospital of Anguo City

    Baoding, Hebei

  • Wangdu County Hospital,Hebei Province

    Baoding, Hebei

  • Baotou City Central Hospital

    Baotou, Inner Mongolia

  • Sinopharm North Hospital

    Baotou, Inner Mongolia

  • The First Affiliated Hospital of Baotou Medical College

    Baotou, Inner Mongolia

  • The people's Hospital of Wulateqianqi

    Bayan Nur, Inner Mongolia

  • Wuyuan County People's Hospital

    Bayan Nur, Inner Mongolia

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100070

  • Beijing Shunyi Airport Hospital

    Beijing, Beijing Municipality

  • Beijing Shunyi Hospital

    Beijing, Beijing Municipality

  • Fuxing Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • The First Hospital of Fangshan District, Beijing

    Beijing, Beijing Municipality

  • Zhejiang Provincial People's Hospital Bijie Hospital

    Bijie, Guizhou

  • Binzhou Central Hospital

    Binzhou, Shandong

  • Yangxin County People Hospital

    Binzhou, Shandong

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin

  • Affiliated Hospital of Chengde Medical University

    Chengde, Hebei

  • Chengde County Hospital

    Chengde, Hebei

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan

  • The First People's Hospital of Longquanyi Disdrict,Chengdu

    Chengdu, Sichuan

  • Chenzhou No.1 People's Hospital

    Chenzhou, Hunan

  • The Fourth People's Hospital of Chenzhou

    Chenzhou, Hunan

  • The Third People's Hospital of Chenzhou

    Chenzhou, Hunan

  • Chongqing Sanbo Chang 'an Hospital

    Chongqing, Chongqing Municipality

  • Chongqing Tungwah Hospital

    Chongqing, Chongqing Municipality

  • Chongqing University Fuling Hospital

    Chongqing, Chongqing Municipality

  • The First Affiliated Hospital of Chongqing Medical and Pharmaceutical College

    Chongqing, Chongqing Municipality

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

  • Xiushan Tujia and Miao Autonomous County People's Hospital

    Chongqing, Chongqing Municipality

  • Affiliated Zhongshan Hospital of Dalian University

    Dalian, Liaoning

  • Central Hospital of Wafangdian

    Dalian, Liaoning

  • Central Hospital of Zhuanghe City

    Dalian, Liaoning

  • Dalian Jinzhou District First People's Hospital

    Dalian, Liaoning

  • Dalian Lvshun District Hospitai of tradition Chinese Medicine

    Dalian, Liaoning

  • Dalian Lvshun District People's Hospital

    Dalian, Liaoning

  • Dalian Municipal Central Hospital

    Dalian, Liaoning

  • Dalian PuLanDian central hospital

    Dalian, Liaoning

  • Dalian University Affiliated Xinhua Hospital

    Dalian, Liaoning

  • People's Hospital of Deyang City

    Deyang, Sichuan

  • Dengzhou Central Hospital

    Dezhou, Henan

  • Ningjin People's Hospital

    Dezhou, Shandong

  • People's Hospital of Qihe County

    Dezhou, Shandong

  • The Second People's Hospital of Dongying

    Dongying, Shandong

  • The First People's Hospital of Foshan

    Foshan, Guangdong

  • Linquan County People's Hospital

    Fuyang, Anhui

  • Fuzhou First People's Hospital of Jiangxi Province

    Fuzhou, Jiangxi

  • Nanfang Hospital，Ganzhou

    Ganzhou, Jiangxi

  • Guangdong second Provincial Central Hospital

    Guangzhou, Guangdong

  • The First Affiliated Hospital of Jinan University

    Guangzhou, Guangdong

  • The First People's Hospital of Guiyang

    Guiyang, Guizhou

  • The Second People's Hospital of Guiyang

    Guiyang, Guizhou

  • The Third People's Hospital of Guiyang

    Guiyang, Guizhou

  • Guihang Guiyang hospital

    Guizhou, Guiyang

  • Guyuan people's hospital

    Guyuan, Ningxia

  • The Second Affiliated Hospital of Hainan Medical University

    Haikou, Hainan

  • Guantao county central Hospital

    Handan, Hebei

  • Handan First Hospital

    Handan, Hebei

  • Qiu County Hospital of Traditional Chinese Medicine

    Handan, Hebei

  • Qiu County People's Hospital

    Handan, Hebei

  • The First People's Hospital of jiande

    Hangzhou, Zhejiang

  • The 2nd Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

  • Hebi Coal Industry (Group) Co., Ltd. General Hospital

    Hebi, Henan

  • Hejian People's Hospital

    Hejian, Hebei

  • Hengshui People's Hospital

    Hengshui, Hebei

  • The No.4 People's Hospital of Hengshui(Department of Neurology ward 1)

    Hengshui, Hebei

  • The No.4 People's Hospital of Hengshui(Department of Neurology ward 2)

    Hengshui, Hebei

  • Hengyang Central Hospital

    Hengyang, Hunan

  • The Fifth Affiliated Hospital of Jinan University (Heyuan Shenhe People's Hospital)

    Heyuan, Guangdong

  • Yuncheng County People's Hospital

    Heze, Shandong

  • Juancheng County People's Hospital

    Heze

  • Huhhot First Hospital

    Hohhot, Inner Mongolia

  • Inner Mongolia International Mongolian Hospital

    Hohhot, Inner Mongolia

  • Inner Mongolia People's Hospital

    Hohhot, Inner Mongolia

  • Tuoketuo County Hospital

    Hohhot, Inner Mongoria

  • Huangshan City People's Hospital

    Huangshan City, Anhui

  • Huizhou First Hospital

    Huizhou, Guangdong

  • The Second People's Hospital of Huludao

    Huludao, Liaoning

  • Inner Mongolia Forestry General Hospital

    Hulunbuir, Inner Mongolia

  • People's Hospital of Anji

    Huzhou, Zhejiang

  • Boai People's Hospital

    Jiaozuo, Henan

  • Mengzhou Hospital of Traditional Chinese Medicine

    Jiaozuo, Henan

  • Mengzhou People's Hospital(Department of Neurology ward 1)

    Jiaozuo, Henan

  • Mengzhou People's Hospital(Department of Neurology ward 2)

    Jiaozuo, Henan

  • Qinyang City Hospital of Traditional Chinese Medicine

    Jiaozuo, Henan

  • Qinyang People's Hospital

    Jiaozuo, Henan

  • Wuzhi County People's Hospital

    Jiaozuo, Henan

  • Xiuwu County People's Hospital

    Jiaozuo, Henan

  • Haiyan People's Hospital

    Jiaxing, Zhejiang

  • Affiliated Hospital of Shandong University of Traditional Chinese Medicine

    Jinan, Shandong

  • Jingdezhen No.1 People's Hospital

    Jingdezhen, Jiangxi

  • Jiujiang No.1 People's Hospital

    Jiujiang, Jiangxi

  • Jiujiang University Affiliated Hospital

    Jiujiang, Jiangxi

  • Jiyuan Hospital of Traditional Chinese Medicine

    Jiyuan, Henan

  • Kaifeng Central Hospital

    Kaifeng, Henan

  • Lankao County Central Hospital

    Kaifeng, Henan

  • Weishi Central Hospital

    Kaifeng, Henan

  • The People's Hospital of the Qiandongnan Miao and Dong Autonomous Prefecture

    Kaili, Guizhou

  • The second Affiliated Hospital of Guizhou Medical University

    Kaili, Guizhou

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan

  • The First People's Hospital of Lanzhou City

    Lanzhou, Gansu

  • Guanxian People's Hospital

    Liaocheng, Shandong

  • Liaocheng City Central Hospital

    Liaocheng, Shandong

  • Liaocheng People's Hospital（Liaocheng Brain Hospital）

    Liaocheng, Shandong

  • Liaocheng People's Hospital

    Liaocheng, Shandong

  • The People's Hospital of Gaotang

    Liaocheng, Shandong

  • The people's Hospital of Linqing

    Liaocheng, Shandong

  • The Second People's Hospital of Liaocheng

    Liaocheng, Shandong

  • Third People's Hospital of Liaocheng

    Liaocheng, Shandong

  • Yanggu Traditional Chinese Medical Hospital

    Liaocheng, Shandong

  • Linfen Central Hospital (neurology department)

    Linfen, Shanxi

  • Linfen Central Hospital(emergency department)

    Linfen, Shanxi

  • Linyi Central Hospital

    Linyi, Shandong

  • Linyi People's Hospital

    Linyi, Shandong

  • Linyi Third People's Hospital

    Linyi, Shandong

  • Linyi Traditional Chinese Medicine Hospital

    Linyi, Shandong

  • People's Hospital of Yinan

    Linyi, Shandong

  • Luoning County People's Hospital

    Luoyang, Henan

  • Luoyang Central Hospital

    Luoyang, Henan

  • Luoyang Dongfang People's Hospital

    Luoyang, Henan

  • Luoyang First People's Hospital

    Luoyang, Henan

  • Luoyang Mengjin District People's Hospital

    Luoyang, Henan

  • Ruyang People's Hospital

    Luoyang, Henan

  • The Second Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan

  • Yiyang County People's Hospital

    Luoyang, Henan

  • Meihekou Central Hospital

    Meihekou, Jilin

  • The Third Hospital of Mianyang

    Mianyang, Sichuan

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi

  • Nanjing Gaochun People's Hospital

    Nanjing, Jiangsu

  • Jiangsu Rudong County People's Hospital

    Nantong, Jiangsu

  • Nantong Tongzhou District No.8 People's Hospital

    Nantong, Jiangsu

  • Suxitong Science and Technology Industrial Park People's Hospital

    Nantong, Jiangsu

  • The People's Hospital of Rugao

    Nantong, Jiangsu

  • The Sixth People's Hospital of Nantong

    Nantong, Jiangsu

  • Nanyang Second General Hospital

    Nanyang, Henan

  • Neixiang County People's Hospital

    Nanyang, Henan

  • Xichuan County People's Hospital

    Nanyang, Henan

  • Xixia County People's Hospital

    Nanyang, Henan

  • The Second People's Hospital of Neijiang

    Neijiang, Sichuan

  • Ningde People's Hospital

    Ningde, Fujian

  • Yunnan Nujiang Lisu Autonomous Prefecture People's Hospital

    Nujiang, Yunnan

  • Ordos central hospital

    Ordos, Inner Mongolia

  • Panjin Central Hospital

    Panjin, Liaoning

  • Panzhihua Central Hospital

    Panzhihua, Sichuan

  • Ruzhou People's Hospital

    Pingdingshan, Henan

  • The second people's hospital of Pingdingshan

    Pingdingshan, Henan

  • Ye County People's Hospital

    Pingdingshan, Henan

  • Ninger County People's Hospital

    Pu'er, Yunnan

  • Fanxian People's Hospital

    Puyang, Henan

  • Puyang County People's Hospital

    Puyang, Henan

  • Qingfeng xinxing hospital

    Puyang, Henan

  • Qingdao Fuwai Cardiovascular Hospital

    Qingdao, Shandong

  • Qixia City People's Hospital

    Qixian, Shandong

  • The First People Hospital of Lingbao

    Sanmenxia, Henan

  • The Sanming First Hospital Affiliated to Fujian Medical University

    Sanming, Fujian

  • Shanghai Seventh People's Hospital

    Shanghai, Shanghai Municipality

  • Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine

    Shanghai, Shanghai Municipality

  • Sui county traditional Chinese medicine hospital

    Shangqiu, Henan

  • The Fourth People's Hospital of Shangqiu

    Shangqiu, Henan

  • The Shangqiu First People's Hospital

    Shangqiu, Henan

  • Zhecheng People's Hospital

    Shangqiu, Henan

  • ShangRao People's Hospital

    Shangrao, Jiangxi

  • Yugan Xinjiang hospital

    Shangrao, Jiangxi

  • Shaodong People's Hospital

    Shaoyang, Hunan

  • Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

    Shenyang, Liaoning

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning

  • The People's Hospital of Liaoning Province

    Shenyang, Liaoning

  • The First Affiliated Hospital of Shihezi University

    Shihezi, Xinjiang

  • Shijiazhuang Third Hospital

    Shijiazhuang, Hebei

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • Hongxinglong Hospital of Beidahuang Group

    Shuangyashan, Heilongjiang

  • Siping Central People's Hospital

    Siping, Jilin

  • Nanjing Drum Tower Hospital Group Suqian Hospital

    Suqian, Jiangsu

  • Siyang kangda hospital

    Suqian, Jiangsu

  • Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi

  • Shanxi Cardiovascular Hospital

    Taiyuan, Shanxi

  • Xinghua City People's Hospital

    Taizhou, Jiangsu

  • North China University of Science And Technology Affiliated Hospital

    Tangshan, Hebei

  • Tangshan Gongren Hospital

    Tangshan, Hebei

  • Tengchong People's Hospital

    Tengyue, Yunnan

  • Affiliated Hospital of Inner Mongolia Minzu University

    Tongliao, Inner Mongolia

  • Tongliao City Hospital

    Tongliao, Inner Mongolia

  • Ulanpab Central Hospital

    Ulanqab, Inner Mongolia

  • People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China

    Ürümqi, Xinjiang

  • Weihai Wendeng District People's Hospital

    Weihai, Shandogn

  • Weihai Central Hospital

    Weihai, Shandong

  • Weihai Municipal Hospital

    Weihai, Shandong

  • The people's Hospital of Wuhai

    Wuhai, Inner Mongolia

  • The First Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui

  • The First People's Hospital of Wuhu

    Wuhu, Anhui

  • Jiangyin People's Hospital

    Wuxi, Jiangsu

  • Yixing People's Hospital

    Wuxi, Jiangsu

  • The People's Hospital of Cenxi City

    Wuzhou, Guangxi

  • East District of The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi

  • Xi 'an Fengcheng Hospital

    Xi'an, Shaanxi

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian

  • The Second affiliated Hospital of Xiamen Medical College

    Xiamen, Fujian

  • The Third Hospital of Xiamen

    Xiamen, Fujian

  • Xianyang Hospital of Yan 'an University

    Xianyang, Shaanxi

  • Qinghe people's hospital

    Xingtai, Hebei

  • Werixian People's Hospital

    Xingtai, Hebei

  • Qianxinan Buyi and Miao Autonomous Prefecture People's Hospital

    Xingyi, Guizhou

  • Huixian People's Hospital

    Xinxiang, Henan

  • The second People Hospital of Xinxiang Henan

    Xinxiang, Henan

  • Xinxiang tongmeng hospital

    Xinxiang, Henan

  • The Affiliated Hospital of Xinyang Vocational and Technical College

    Xinyang, Henan

  • The Second Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu

  • Zichang People's Hospital

    Yan’an, Shaanxi

  • Qixia traditional Chinese medicine hospital

    Yantai, Shandong

  • Yantai Affiliated Hospital of Binzhou Medical University

    Yantai, Shandong

  • Yantai Penglai People's Hospital

    Yantai, Shandong

  • Yantai Penglai traditional Chinese medicine hospital

    Yantai, Shandong

  • Yantai Taocun Central Hospital

    Yantai, Shandong

  • Yantai Yuhuangding Hospital

    Yantai, Shandong

  • Yantai Zhifu hospital

    Yantai, Shandong

  • YEDA hospital

    Yantai, Shandong

  • Tonggu County People's Hospital

    Yichun, Jiangxi

  • Yichun People's Hospital

    Yichun, Jiangxi

  • Central Hospital of Yongcheng

    Yongcheng, Henan

  • Yueyang People's Hospital

    Yueyang, Hunan

  • Yicheng Municipal Hospital of Zaozhuang

    Zaozhuang, Shandong

  • The First Affiliated Hospital of Hebei North University

    Zhangjiakou, Hebei

  • Zhangye People's Hospital Affiliated To Hexi University

    Zhangye, Gansu

  • Xingyang People's Hospital

    Zhengzhou, Henan

  • Xinmi Hospital of T.C.M

    Zhengzhou, Henan

  • People's Hospital of Zhongwei

    Zhongwei, Ningxia

  • Shenqiu County People's Hospital

    Zhoukou, Henan

  • Taikang Xian People's Hospital

    Zhoukou, Henan

  • Xihua Xian People's Hospital

    Zhoukou, Henan

  • Zhumadian TCM Hospital

    Zhumadian, Henan

  • PKUcare Zibo Hospital

    Zibo, Shandong

  • Zibo Central Hospital

    Zibo, Shandong

  • Zibo Hospital of Traditional Chinese Medicine

    Zibo, Shandong

  • Zibo Municipal Hospital

    Zibo, Shandong

Other trials in China

About this study

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.

Read the 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.

Conditions
Ischemic Stroke, TIA
Being tested
Colchicine, Placebo colchicine
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ColchicineDrug

    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 colchicineDrug

    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.

Study groups in NCT05439356
Study groupRoleWhat they receive
Colchicine GroupExperimentalPatients in this arm will receive colchicine for 90 days in addition to standard medical care
Receives: Drug: Colchicine
Placebo Colchicine GroupPlacebo comparatorPatients in this arm will receive placebo colchicine for 90 days in addition to standard medical care
Receives: Drug: Placebo colchicine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Any new stroke events

    Incidence of any new ischemic or hemorrhagic stroke

    Measured: any time within 90 days

Secondary outcomes (5)

  1. New vascular events

    Incidence of any new vascular events, including ischemic stroke, hemorrhagic stroke, TIA, myocardial infarction and vascular death

    Measured: any time within 90 days

  2. New ischemic stroke

    Incidence of any new ischemic stroke

    Measured: any time within 90 days

  3. 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)

    Measured: at 90 days after randomization

  4. New stroke and TIA

    Incidence of any new stroke and TIA

    Measured: any time within 90 days

  5. 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

    Measured: within 90 days after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2022
  2. Study start11 Aug 2022
  3. Primary completion13 Jul 2023
  4. Study completion12 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
8,343 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05439356
Sponsor's protocol ID
NCRC-2022-05
Status last verified
Jun 2024
First submitted
20 Jun 2022
Last updated
25 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data collected for the study can be made available to other researchers on reasonable request and after signing appropriate data sharing agreements.

Publications

  • Li J, Jing J, Meng X, Shi FD, Gu HQ, Jin A, Jiang Y, Li H, Johnston SC, Hankey GJ, Easton JD, Xie X, Jin WN, Chang L, Shi P, Wang L, Zhuang X, Li H, Zang Y, Zhang J, Sun Z, Liu D, Li Y, Yang H, Zhao J, Yu W, Wang A, Pan Y, Lin J, Li S, Niu S, Wang Y, Zhao X, Li Z, Liu L, Zheng H, Wang Y; CHANCE-3 Investigators. Colchicine for preventing stroke in patients with and without intracranial atherosclerotic stenosis: a prespecified analysis of a randomized clinical trial. EClinicalMedicine. 2025 May 19;84:103226. doi: 10.1016/j.eclinm.2025.103226. eCollection 2025 Jun.

    PubMed 40496882

  • Li J, Meng X, Shi FD, Jing J, Gu HQ, Jin A, Jiang Y, Li H, Johnston SC, Hankey GJ, Easton JD, Chang L, Shi P, Wang L, Zhuang X, Li H, Zang Y, Zhang J, Sun Z, Liu D, Li Y, Yang H, Zhao J, Yu W, Wang A, Pan Y, Lin J, Xie X, Jin WN, Li S, Niu S, Wang Y, Zhao X, Li Z, Liu L, Zheng H, Wang Y; CHANCE-3 Investigators. Colchicine in patients with acute ischaemic stroke or transient ischaemic attack (CHANCE-3): multicentre, double blind, randomised, placebo controlled trial. BMJ. 2024 Jun 26;385:e079061. doi: 10.1136/bmj-2023-079061.

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Colchicine in people with Ischemic Stroke and TIA, run by Beijing Tiantan Hospital at 244 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 244 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Any new stroke events (time frame: any time within 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05439356, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.

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