AzTrials
AzTrials

StrokePhase 3CHANCE-2NCT04078737

Clopidogrel With Aspirin in High-risk Patients With Acute Non-disabling Cerebrovascular Events II

A Phase 3 study testing Ticagrelor and Aspirin and Clopidogrel and Aspirin in people with Stroke and Transient Ischemic Attack, run by Beijing Tiantan Hospital at 214 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

The primary objective of this trial is to assess the effects of ticagrelor plus aspirin versus clopidogrel plus aspirin on reducing the 3-month risk of any stroke (both ischemic and hemorrhagic, primary outcome) when initiated within 24 hours of symptom onset in CYP2Y19 LOF alleles carriers with TIA or minor stroke. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Stroke, Transient Ischemic Attack
What is being tested?
Ticagrelor and Aspirin and Clopidogrel and Aspirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6,412 participants
Where
214 sitesChina
Study dates
23 Sep 2019to 1 Jul 2021
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 non-disabling ischemic stroke (NIHSS≤3 at the time of randomization)or，
  • TIA with moderate-to-high risk of stroke (ABCD2 score ≥ 4 at the time of randomization)；
  • Can be treated with study drug within 24 hours of symptoms onset*(*Symptom onset is defined by the "last seen normal" principle)；
  • CYP2C19 loss-of-function allele carriers；
  • 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 minor stroke or TIA.
  • Preceding moderate or severe dependency (modified Rankin scale [mRS] score 3-5).
  • Contraindication to clopidogrel, ticagrelor or aspirin
  • Known allergy
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  • Severe renal (creatinine exceeding 1.5 times of the upper limit of normal range) or hepatic (ALT or AST > twice the upper limit of normal range) insufficiency
  • Severe cardiac failure (NYHA level: III to IV)
  • History of hemostatic disorder or systemic bleeding
  • History of thrombocytopenia or neutropenia
  • History of drug-induced hematologic disorder or hepatic dysfunction
  • Low white blood cell (<2×109/L) or platelet count (<100×109/L)
  • Hematocrit (HCT) <30%
  • Clear indication for anticoagulation (presumed cardiac source of embolus, e.g., atrial fibrillation, prosthetic cardiac valves known or suspected endocarditis)
  • History of intracranial hemorrhage or amyloid angiopathy
  • History of aneurysm (including intracranial aneurysm and peripheral aneurysm)
  • History of asthma or COPD (chronic obstructive pulmonary disease)
  • High-risk for bradyarrhythmia (first-degree or second-degree AV block caused by sinus node disease, and brady-arrhythmic syncope without pacemaker)
  • History of hyperuricemia nephropathy
  • Anticipated requirement for long-term (>7 days) non-steroidal anti-inflammatory drugs (NSAIDs)
  • Planned or likely revascularization (any angioplasty or vascular surgery) within the next 3 months
  • Scheduled for surgery or interventional treatment requiring study drug cessation
  • Severe non-cardiovascular comorbidity with life expectancy < 3 months
  • Inability to understand and/or follow research procedures due to mental, cognitive, or emotional disorders
  • Dual antiplatelet treatment (or more than two antiplatelet agents) in 72 hours before randomization
  • Current treatment (last dose given within 10 days before randomization) with heparin therapy or oral anti coagulation
  • Intravenous thrombolytic therapy (such as intravenous rtPA) or mechanical thrombectomy within 24 hours prior to randomization
  • Gastrointestinal bleed within 3 months or major surgery within 30 days
  • Diagnosis or suspicious diagnosis of acute coronary syndrome
  • Participation in another clinical study with an experimental product during the last 30 days
  • Currently receiving an experimental drug or device
  • Pregnant, currently trying to become pregnant, or of child-bearing potential and not using birth control

Trial locations and contacts

214 sites in 1 country.

214 sites in 1 country

China214 sites

  • Anqing Municipal Hospital

    Anqing, Anhui, 246003

  • Anyang People's Hospital

    Anyang, Henan, 455000

  • Affiliated Hospital of Hebei Medical University

    Baoding, Hebei, 071000

  • Affiliated Hospital of Hebei University

    Baoding, Hebei, 071000

  • Baoji High-tech People's Hospital

    Baoji, Shaanxi, 721000

  • The first Affiliated Hospital of Baotou Medical College

    Baotou, Inner Mongolia, 014010

  • Baotou CentralHospital

    Baotou, Inner Mongolia, 014040

  • The second Affiliated Hospital of Baotou Medical College

    Baotou, Inner Mongolia, 14030

  • Wuyuan County People's Hospital

    Bayan Nur, Inner Mongolia, 15100

  • Beijing Chaoyang Hospital, Capital MedicalUniversity（west Hospital）

    Beijing, Beijing Municipality, 100043

  • Beijing Tian tan Hospital

    Beijing, Beijing Municipality, 100070

  • Beijing Shunyi Airport Hospital

    Beijing, Beijing Municipality, 101318

  • The First Hospital of Fangshan District

    Beijing, Beijing Municipality, 102488

  • Beijing Coal Group Hospital

    Beijing, Beijing Municipality

  • Peking University Third Hospital

    Beijing, Beijing Municipality

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233004

  • Hulun Buir People's Hospital

    Buri, Inner Mongolia, 21000

  • Sino-Japanese Friendship Hospital Of Jilin University

    Changchun, Jilin, 130031

  • The First Hospital Of Jilin University

    Changchun, Jilin, 130031

  • Jilin Provincial People's Hospital

    Changchun, Jilin

  • Changge People's Hospital

    Changge, Henan, 461500

  • First hospital of Changsha city

    Changsha, Hunan, 410005

  • Changzhi People's Hospital

    Changzhi, Shanxi, 046000

  • Heping Hospital affiliated to Changzhi Medical College

    Changzhi, Shanxi, 046000

  • The Affiliated Hospital of Chengde Medical College

    Chengde, Hebei, 067000

  • West China Hospital Of Sichuan University

    Chengdou, Sichuan, 610041

  • Chengdu second Municipal People'sHospital

    Chengdu, Sichuan, 610000

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072

  • Chenzhou First People's Hospital

    Chenzhou, Hunan, 423000

  • Fourth People's Hospital of Chenzhou

    Chenzhou, Hunan, 423000

  • Chifeng City Hospital

    Chifeng, Inner Mongolia, 024000

  • Affiliated Hospital of Chifeng University

    Chifeng, Inner Mongolia, 024005

  • Chongqing People's Hospital

    Chongqing, Chongqing Municipality, 400010

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400010

  • Chongqing Sanbo Chang 'an Hospital

    Chongqing, Chongqing Municipality, 400023

  • Daping Hospital of Army Military Medical University

    Chongqing, Chongqing Municipality, 400042

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400060

  • Chongqing Fifth People's Hospital

    Chongqing, Chongqing Municipality, 400062

  • The Third Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 401120

  • People's Hospital of Rongchang District, Chongqing,

    Chongqing, Chongqing Municipality, 402460

  • Chongqing Three Gorges Central Hospital

    Chongqing, Chongqing Municipality, 404000

  • Chongqing Kaizhou District People's Hospital

    Chongqing, Chongqing Municipality, 405400

  • Chongqing Fuling Central Hospital

    Chongqing, Chongqing Municipality, 408000

  • Chongqing Nanchuan District People's Hospital

    Chongqing, Chongqing Municipality, 408400

  • Xiushan Tujia and Miao Autonomous County People's Hospital

    Chongqing, Chongqing Municipality, 409900

  • Xinhua Hospital affiliated to Dalian University

    Dalian, Liaoning, 116023

  • Hainan West Central Hospital

    Danzhou, Hainan, 571799

  • Daqing Oilfield Gengeal Hospital

    Daqing, Heilongjiang, 163001

  • Daqing People's Hospital

    Daqing, Heilongjiang, 163361

  • Datong Fifth People's Hospital

    Datong, Shanxi, 037000

  • The Third People's Hospital of Datong

    Datong, Shanxi, 037008

  • dazhou Central Hospital

    Dazhou, Sichuan, 635099

  • Dezhou People's Hospital

    Dezhou, Shandong, 2530000

  • Ningjin County People's Hospital

    Dezhou, Shandong, 253400

  • Dongguan People's Hospital

    Dongguan, Guangdong, 523000

  • The Third Affiliated Hospital of Fujian University of Traditional Chinese Medicine

    Fuzhou, Fujian, 350025

  • Fuzhou Second Hospital

    Fuzhou, Fujian

  • Ganzhou city people's Hospital

    Ganzhou, Jiangxi, 341000

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510260

  • Nanfang Hospital Of Southern Medical University

    Guangzhou, Guangdong, 510515

  • The First Affiliated Hospital of Jinan University

    Guangzhou, Guangdong, 510632

  • Guiyang Second People's Hospital

    Guiyang, Guizhou, 550000

  • Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550004

  • First Affiliated Hospital of Xinjiang Medical University

    Guiyang, Xinjiang Autonomous Region, 8300054

  • Guyuan people's hospital

    Guyuan, Ningxia, 756000

  • The First Affiliated Hospital of Hainan Medical University

    Haikou, Hainan, 570102

  • Hangzhou first people's Hospital

    Hangzhou, Zhejiang, 310006

  • The First Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

  • The Second Hospital of Harbin Medical University（Department of Neurology ward 1）

    Harbin, Heilongjiang, 150086

  • The Second Hospital of Harbin Medical University（Department of Neurology ward ）

    Harbin, Heilongjiang, 150086

  • Hejian People's Hospital

    Hejian, Hebei, 062450

  • HaLixun InternationalPeace Hospital

    Hengshui, Hebei, 053000

  • Hengshui fourth People Hospital（Department of Neurology ward 2）

    Hengshui, Hebei, 053000

  • The Fourth People's Hospital of Hengshui City（Department of Neurology ward 1）

    Hengshui, Hebei, 053000

  • The First Affiliated Hospital of Nanhua University

    Hengyang, Hunan, 421001

  • Inner Mongolia People's Hospital

    Hohhot, Inner Mongolia, 010017

  • Inner Mongolia International Mongolian Hospital

    Hohhot, Inner Mongolia, 010069

  • Huaian Hospital of Traditional Chinese Medicine

    Huai'an, Jiangsu, 223001

  • Lianshui County People's Hospital

    Huai'an, Jiangsu, 223400

  • Second People's Hospital of Huludao City

    Huludao, Liaoning

  • The First Affiliated Hospital of Jiamusi University

    Jiamusi, Heilongjiang, 154002

  • Xiuwu County People's Hospital

    Jiaozuo, Henan, 454350

  • Shandong Provincial Hospital

    Jinan, Shandong, 250021

  • The First People's Hospital of Jingdehzne City

    Jingdezhen, Jiangxi, 333000

  • Affiliated Hospital of Jiujiang College

    Jiujiang, Jiangxi, 332000

  • Jiujiang first people's Hospital

    Jiujiang, Jiangxi, 332000

  • Jiyuan People's Hospital

    Jiyuan, Henan, 459000

  • Kaifeng Central Hospital

    Kaifeng, Henan, 475000

  • weishi county Central Hospital

    Kaifeng, Henan, 475500

  • First People's Hospital of Yunnan Province

    Kunming, Yunnan, 650000

  • The Second People's Hospital of Lianyungang

    Lianyungang, Jiangsu, 222023

  • Liaocheng City Third People's Hospital

    Liaocheng, Shandong, 252000

  • Liaocheng People's Hospital

    Liaocheng, Shandong, 252000

  • Liaocheng Veterans Hospital

    Liaocheng, Shandong, 252000

  • The Brain Hospital of Liaocheng People's Hospital

    Liaocheng, Shandong, 252000

  • Guanxian People's Hospital

    Liaocheng, Shandong, 252500

  • Liaocheng City Second People's Hospital

    Liaocheng, Shandong, 252601

  • Dongchangfu people's Hospital

    Liaocheng, Shandong

  • Liaocheng Central Hospital

    Liaocheng, Shandong

  • Linqing People's Hospital

    Linqing, Shandong, 252600

  • lishui municipal Central Hospital

    Lishui, Zhejiang, 323000

  • Loudi City Central Hospital

    Loudi, Hunan, 417000

  • Luohe Central Hospital

    Luohe, Henan, 462000

  • Luoyang Central Hospital

    Luoyang, Henan, 471000

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

    Luoyang, Henan, 471000

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

    Luoyang, Henan, 471000

  • Luoyang New District People's Hospital

    Luoyang, Henan, 471023

  • Hongqi Hospital affiliated to Mudanjiang Medical University

    Mudanjiang, Heilongjiang, 157000

  • First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330000

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi, 330006

  • Nanjing Jiangning Hospital

    Nanjing, Jiangsu, 210000

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210003

  • Nanjing Gulou Hospital

    Nanjing, Jiangsu, 210008

  • BenQ Hospital affiliated to Nanjing Medical University

    Nanjing, Jiangsu, 210019

  • Jiangsu Provincial Hospital of Traditional Chinese Medicine

    Nanjing, Jiangsu, 210029

  • Nanjing Brain Hospital

    Nanjing, Jiangsu, 210029

  • The Fourth Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210031

  • Nanjing Jiangbei People's Hospital

    Nanjing, Jiangsu, 210048

  • Nanjing Gaochun People's Hospital

    Nanjing, Jiangsu, 211300

  • Nantong 6th People's Hospital

    Nantong, Jiangsu, 226000

  • Nantong Hospital of Traditional Chinese Medicine

    Nantong, Jiangsu, 226000

  • The Third People's Hospital in Tongzhou District, Nantong

    Nantong, Jiangsu, 226000

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu, 226001

  • Nantong First People's Hospital

    Nantong, Jiangsu, 226001

  • Nantong Second People's Hospital

    Nantong, Jiangsu, 226002

  • Nantong Fourth People's Hospital

    Nantong, Jiangsu, 226005

  • Nantong Third People's Hospital

    Nantong, Jiangsu, 22600

  • Tongzhou District People's Hospital of Nantong City

    Nantong, Jiangsu, 226300

  • Rudong County People's Hospital

    Nantong, Jiangsu, 226400

  • Rugao People's Hospital

    Nantong, Jiangsu, 226500

  • Hai 'an People's Hospital

    Nantong, Jiangsu, 226600

  • Tongzhou District 8th People's Hospital of Nantong City

    Nantong, Jiangsu

  • Pingdingshan First People's Hospital

    Pingdingshan, Henan, 467000

  • Qingdao Municipal Hospital

    Qingdao, Shandong, 266000

  • Affiliated Hospital of Qingdao University Medical College

    Qingdao, Shandong, 266071

  • Qingdao West Coast New Area People's Hospital

    Qingdao, Shandong, 266400

  • Qiqihar Rongjian Institute of Stroke Prevention and Treatment

    Qiqihar, Heilongjiang

  • Zhejiang Wenzhou Medical College Third Affiliated Hospital

    Ruian, Zhejiang, 325200

  • Sanmenxia Central Hospital

    Sanmenxia, Henan, 472000

  • Sanming First Hospital Affiliated to Fujian Medical University

    Sanming, Fujian, 100043

  • Putuo District Central Hospital

    Shanghai, Shanghai Municipality, 200062

  • Shanghai 7th People's Hospital

    Shanghai, Shanghai Municipality, 200137

  • Shangqiu Fourth People's Hospital

    Shangqiu, Henan, 476000

  • Suixian county Hospital of Traditional Chinese Medicine

    Shangqiu, Henan, 476900

  • Shangrao City People's Hospital

    Shangrao, Jiangxi

  • The first Affiliated Hospital of Shantou University Medical College

    Shantou, Guangdong, 515041

  • shaoyang Central Hospital

    Shaoyang, Hunan

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

  • First People's Hospital of Shenyang

    Shenyang, Liaoning, 110041

  • Shenzhen Integrated Chinese and Western Medicine Hospital

    Shenzhen, Shenzhen, 100191

  • Shenzhen Luohu People's Hospital

    Shenzhen, Shenzhen, 518001

  • Shenzhen Second People's Hospital

    Shenzhen, Shenzhen, 518035

  • Huazhong University of Science and Technology Union Shenzhen Hospital

    Shenzhen, Shenzhen, 518052

  • The Second Hospitalof Hebei Medical University

    Shijiazhuang, Hebei, 050000

  • The Fifth People's Hospital of Ningxia Hui Autonomous Region

    Shizuishan, Ningxia, 753000

  • The Second People's Hospital of Shizuishan

    Shizuishan, Ningxia, 753000

  • Shizuishan First People's Hospital

    Shizuishan, Ningxia, 753200

  • Second people's Hospital of shizuishan

    Shizuishan, Ningxia, 753400

  • Siyang County People's Hospital

    Suqian, Jiangsu, 223700

  • Siyang Kangda Hospital

    Suqian, Jiangsu, 223700

  • Suqian People's Hospital

    Suqian, Jiangsu, 223800

  • Suzhou Municipal Hospital

    Suzhou, Jiangsu, 215000

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215004

  • Shanxi cardiovascular disease hospital

    Taiyuan, Shanxi, 030024

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 30000

  • Taiyuan Iron and Steel (Group) Co, Ltd,General Hospital

    Taiyuan, Shanxi, 30001

  • The First Hospital of Shanxi Medical University

    Taiyuan, Shanxi

  • Taizhou People's Hospital

    Taizhou, Jiangsu, 225300

  • Xinghua People's Hospital

    Taizhou, Jiangsu, 225700

  • Taizhou First People's Hospital

    Taizhou, Zhejiang, 318020

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

  • People's Hospital Of Xinjiang Uygur Autonomous Region

    Ürümqi, Xinjiang Autonomous Region, 830001

  • Affiliated Hospital of Weifang Medical University

    Weifang, Shandong

  • Sunshine Union Hospital

    Weifang, Shandong

  • weihai Central Hospital

    Weihai, Shandong, 264400

  • Wendeng District People's Hospital

    Weihai, Shandong, 264400

  • weinan Central Hospital

    Weinan, Shaanxi, 714000

  • Wuhan No.1 Hospital

    Wuhan, Hubei, 430000

  • The Central Hospital of Wuhan

    Wuhan, Hubei, 430014

  • Wuwei People's Hospital

    Wuwei, Gansu, 733000

  • Wuxi People's Hospital

    Wuxi, Jiangsu, 214000

  • Affiliated Hospital of Jiangnan University

    Wuxi, Jiangsu, 214041

  • Yixing People's Hospital

    Wuxi, Jiangsu, 214200

  • Jiangyin People's Hospital

    Wuxi, Jiangsu, 214400

  • Xi 'an Hi-tech Hospital

    Xi'an, Shaanxi, 710000

  • Xi 'an Fengcheng Hospital

    Xi'an, Shaanxi, 710016

  • Xian 141 Hospital

    Xi'an, Shaanxi, 710089

  • Xi 'an First Hospital

    Xi’an, Shanxi

  • Xiangtan Central Hospital

    Xiangtan, Hunan, 411100

  • Xingyang People's Hospital

    Xingyang, Henan, 450100

  • The first Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan, 453100

  • xuzhou Central Hospital

    Xuzhou, Jiangsu, 221000

  • Xuzhou coal mining group General Hospital

    Xuzhou, Jiangsu, 221000

  • Affiliated Hospital of Xuzhou Medical University（Department of Neurology ward 1）

    Xuzhou, Jiangsu, 221002

  • Affiliated Hospital of Xuzhou Medical University（Department of Neurology ward 2）

    Xuzhou, Jiangsu, 221002

  • Subei People's Hospital of Jiangsu province

    Yangzhou, Jiangsu, 225009

  • Affiliated Hospital of Yangzhou University

    Yangzhou, Jiangsu, 225012

  • Penglai People's Hospital

    Yantai, Shandong, 265600

  • Yantai Beihai Hospita

    Yantai, Shandong, 265701

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750001

  • Yinchuan First People's Hospital

    Yinchuan, Ningxia, 750001

  • Cardiovascular and Cerebrovoscular Hospital of General Hospital of Ningxia Med. Univ

    Yinchuan, Ningxia, 750002

  • People's Hospital of Ningxia Hui Autonomous Region

    Yinchuan, Ningxia, 750002

  • Friendship Hospital of Ili Kazak Autonomous Prefecture

    Yining, Xinjiang Autonomous Region, 835000

  • Yueyang Second People's Hospital

    Yueyang, Hunan, 414000

  • The First Affiliated Hospital of Hebei North University

    Zhangjiakou, Hebei, 75000

  • Zhangye People's Hospital Affiliated to Hexi College

    Zhangye, Gansu, 734000

  • The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

    Zhengzhou, Henan, 450000

  • Gongyi People's Hospital

    Zhengzhou, Henan, 451200

  • The fourth peoples hospital of zhenjiang city

    Zhenjiang, Jiangsu, 212001

  • Zhongwei People's Hospital

    Zhongwei, Ningxia, 755000

  • Zhoukou Yongshan Hospital

    Zhoukou, Henan, 461300

  • Zhumadian Hospital of Traditional Chinese Medicine

    Zhumadian, Henan, 463000

  • Second Central Hospital of Baoding

    Zhuozhou, Hebei, 072750

Other trials in China

About this study

The primary objective of this trial is to assess the effects of ticagrelor plus aspirin versus clopidogrel plus aspirin on reducing the 3-month risk of any stroke (both ischemic and hemorrhagic, primary outcome) when initiated within 24 hours of symptom onset in CYP2Y19 LOF alleles carriers with TIA or minor stroke.

Read the detailed description

According to the Global Burden of Disease(GBD) Study 2016, China bears the greatest lifetime risk of stroke from 25-year-age onward. Minor ischemic events, including minor stroke and TIA, were major parts of stroke manifestations. Events (CHANCE) has shown that 21-day dual antiplatelet therapy (clopidogrel and aspirin) compared to aspirin alone which initiated within 24 hours after symptoms onset would reduce 32% risk of stroke recurrence within 90 day, but not in carriers of CYP2C19 loss-of-function (LOF) alleles. The primary purpose of this study is to compare ticagrelor plus aspirin with clopidogrel plus aspirin on reducing the 3-month risk of any stroke (both ischemic and hemorrhagic, primary outcome) when initiated within 24 hours of symptom onset in CYP2Y19 LOF alleles carriers with TIA or minor stroke.

Both intent analysis (ITT) and compliance program set (PPS) were used for analysis.

We will use Kaplan-Meier estimates of the cumulative risk of stroke (ischemic or hemorrhagic) event during maximum 90-day follow-up, with hazards ratios and 95% CI calculated using Cox proportional hazards methods and the log-rank test to evaluate the treatment effect. All statistics will be 2-sided with P<0.05 considered significant, accounting for interim analyses.

All patients who received study drugs and with at least one safety follow-up record will be included in the safety population. The data for safety evaluation included adverse reactions observed during the trial and changes in laboratory data before and after treatment.

Being tested
Ticagrelor and Aspirin, Clopidogrel and Aspirin
Keywords
stroke, transient ischemic attack, acute treatment, acute non-disabling cerebrovascular event, clopidogrel, ticagrelor, clopidogrel combined with ASA, ticagrelor combined with ASA, recurrence of stroke and other vascular events, CYP2C19 loss-of-function allele(s) carrier
Medical subject headings
Stroke, Ischemic Attack, Transient

What participants receive

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

  • Ticagrelor and AspirinDrug

    Day of randomization:

    Day1:Ticagrelor 180mg; placebo of clopidogrel 300mg; aspirin 75-300mg (open label) Day2-21st: Ticagrelor 90mg bid/day; placebo of clopidogrel 75mg; aspirin 75mg (open label) Day 22nd-3 months:Ticagrelor 90mg bid/day; placebo of clopidogrel 75mg

  • Clopidogrel and AspirinDrug

    Day of randomization:

    Day 1: Clopidogrel 300mg; placebo of ticagrelor 180mg; aspirin 75-300mg (open label) Day2-21st: Clopidogrel 75mg/day; placebo of ticagrelor 90mg bid/day; aspirin 75mg (open label) Day 22nd-3 months:Clopidogrel 75mg; placebo of ticagrelor 90mg bid/day

Study groups in NCT04078737
Study groupRoleWhat they receive
Ticagrelor plus Aspirin GroupExperimentalTicagrelor of loading dosing of 180mg followed by 90mg bid for 3 months plus aspirin of loading dose of 75-300mg followed by 75mg daily for 21 days
Receives: Drug: Ticagrelor and Aspirin
Clopidogrel plus Aspirin GroupActive comparatorClopidogrel of loading dosing of 300mg followed by 75mg daily for 3 months plus aspirin loading dose of 75-300mg followed by 75mg daily for 21 days
Receives: Drug: Clopidogrel and Aspirin

What is being measured

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

  1. Any new stroke events (ischemic stroke or hemorrhagic stroke) within 3 months

    The aim is to assess the effects of ticagrelor plus aspirin versus clopidogrel plus aspirin on reducing the 3-month risk of any stroke (both ischemic and hemorrhagic, primary outcome) when initiated within 24 hours of symptom onset in CYP2Y19 LOF alleles carriers with TIA or minor stroke.

    Measured: 3 months after randomization

Secondary outcomes (8)

  1. Any new stroke events within 30 days and 1 year

    Percentage of patients with the 30 days and 1 year new stroke events (ischemic stroke/ hemorrhagic stroke) as a cluster and evaluated individually.

    Measured: 30 days and 1 year after randomization

  2. New clinical vascular events including stroke, TIA, myocardial infarction, and vascular deaths within 3 months and 1 year

    Percentage of patients with the 3 months and 1 year new clinical vascular events (ischemic stroke/ hemorrhagic stroke/ TIA/ myocardial infarction/vascular death)

    Measured: 3 months and 1 year after randomization

  3. New ischemic stroke within 3 months and 1 year

    Percentage of patients with the 3 months and 1 year new ischemic stroke will be evaluated.

    Measured: 3 months and 1 year after randomization

  4. Disabling stroke (Modified Rankin Scale score, mRS>1) at 3 months and 1 year

    Modified Rankin Scale, a commonly used scale for measuring the degree of dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. 0 - No symptoms.1 - No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.3 - Moderate disability. Requires some help, but able to walk unassisted.4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.6 - Dead. The mRS scores between 3 to 6 points are considered to be poor functional outcome. (dead).

    Measured: 3 months and 1 year after randomization

  5. Incidence and severity of recurrent stroke and TIA during follow-up to 3 months and 1-year

    (Severity is measured using a six-level ordered categorical scale that incorporates the mRS: fatal stroke/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: 3 months and 1 year after randomization

  6. Neurological impairment at 3 months (NIHSS increased≥4 from baseline)

    The National Institutes of Health Stroke Scale (NIHSS) score classifies neurologic deficit from 0 (no deficit) to 42 (most severe).

    Measured: 3 months after randomization

  7. Quality of Life (EuroQol EQ-5D scale) at 3 months and at 1 year

    Further efficacy exploratory analysis:Quality of Life (EuroQol EQ-5D scale). We will use the EQ-5D-5L scale to evaluate the quality of life. EQ-5D-5L is a standardized instrument for measuring generic health status. It has been widely used in population health surveys, clinical studies, economic evaluation and in routine outcome measurement in the delivery of operational healthcare. The EQ-5D-5L has five domain scales (mobility, self-care, usual activities, pain and discomfort, and anxiety and depression) and five levels for each domain.

    Measured: 3 months and 1 year after randomization

  8. Stratified analysis

    The influence on treatment effect of age, gender, Body Mass Index (BMI), index event type (TIA vs. minor stroke), time from index event to randomization, etiology subtype, diabetes mellitus, hypertension, type of LOF allele, previous ischemic stroke or TIA, prior antiplatelet therapy, prior statin therapy, prior smoking status, and symptomatic intracranial and extracranial artery stenosis will be evaluated in subgroup analyses.

    Measured: 3 months and 1 year 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 posted6 Sep 2019
  2. Study start23 Sep 2019
  3. Primary completion24 Jun 2021
  4. Study completion1 Jul 2021

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
6,412 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04078737
Sponsor's protocol ID
2017ZX09304018001
Acronym
CHANCE-2
Status last verified
Nov 2021
First submitted
8 Jul 2019
Last updated
2 Dec 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhao J, Tian X, Yang X, Xu Q, Xia X, Zhang Y, Xie X, Bath PM, Jing J, Wang Y, Meng X, Wang A. Effect of insulin resistance on ticagrelor-versus clopidogrel-based dual antiplatelet therapy for secondary prevention of stroke in carriers of CYP2C19 loss-of-function mutations. CMAJ. 2026 Jan 18;198(2):E36-E43. doi: 10.1503/cmaj.241581.

    PubMed 41554550

  • Lin J, Zhou H, Wang Y, Jin A, Li S, Zhang L, Meng X, Xie X, Jing J, Jiang Y, Wang Y, Zhao X, Li H, Li Z, Wang Y; CHANCE-2 Investigators. Lp-PLA2 Activity and Genotype-Guided Dual Antiplatelet Therapy in Minor Stroke or Transient Ischemic Attack. Stroke. 2026 Apr;57(4):890-896. doi: 10.1161/STROKEAHA.125.052954. Epub 2026 Jan 13.

    PubMed 41527826

  • Li H, Xia X, Xu Q, Meng X, Wang Y, Wang A. Differential Effect of Ticagrelor Versus Clopidogrel by Causative Classification of Stroke Classification and Vascular Cellular Adhesion Molecule-1 Level on the Risk of Recurrent Stroke: A Post Hoc Analysis of the CHANCE-2 Trial. J Am Heart Assoc. 2026 Jan 6;15(1):e042259. doi: 10.1161/JAHA.125.042259. Epub 2025 Dec 18.

    PubMed 41413755

  • Feng Z, Zhang F, Jin A, Li X, Li Y, Chu Q, Xue J, Cheng A, Lin J, Li H, Meng X, Wang Y, Xu J. Genotype-guided dual antiplatelet therapy in minor stroke or transient ischemic attack with metabolic syndrome: A post hoc analysis of CHANCE-2. Diabetes Obes Metab. 2026 Jan;28(1):625-633. doi: 10.1111/dom.70243. Epub 2025 Oct 27.

    PubMed 41145384

  • Lin X, Guo C, Meng X, Zhao X, Li H, Wang Y, Yang J. PCISOS Risk Profiles Stratify Heterogeneous Outcomes in Minor Posterior Circulation Ischemic Stroke: A Post Hoc Analysis of the CHANCE-2 Trial. Stroke. 2025 Dec;56(12):3371-3381. doi: 10.1161/STROKEAHA.125.053054. Epub 2025 Sep 10.

    PubMed 40927840

  • Xie X, Jing J, Wang A, Xu Q, Zhao X, Lin J, Chen P, Jiang Y, Wang Y, Li H, Meng X, Wang Y. Dual antiplatelet therapy with ticagrelor vs clopidogrel in patients with TIA or minor stroke with or without symptomatic carotid artery stenosis: a post hoc analysis of the CHANCE-2 trial. Stroke Vasc Neurol. 2025 Oct 27;10(5):551-559. doi: 10.1136/svn-2024-003293.

    PubMed 39773886

  • Xie X, Jing J, Meng X, Johnston SC, Bath PM, Li Z, Zhao X, Wang Y, Xu Q, Wang A, Jiang Y, Li H, Wang Y; CHANCE-2 Investigators. Dual Antiplatelet Therapy After Embolic Stroke of Undetermined Source: A Subgroup Analysis of the CHANCE-2 Trial. Stroke. 2024 Jul;55(7):1739-1747. doi: 10.1161/STROKEAHA.124.046834. Epub 2024 Jun 11.

    PubMed 38860396

  • Wang A, Tian X, Xie X, Li H, Bath PM, Jing J, Lin J, Wang Y, Zhao X, Li Z, Liu L, Wang Y, Meng X. Differential effect of ticagrelor versus clopidogrel by homocysteine levels on risk of recurrent stroke: a post hoc analysis of the CHANCE-2 trial. CMAJ. 2024 Feb 11;196(5):E149-E156. doi: 10.1503/cmaj.231262.

    PubMed 38346785

  • Zhang X, Jing J, Wang A, Xie X, Johnston SC, Li H, Bath PM, Xu Q, Lin J, Wang Y, Zhao X, Li Z, Jiang Y, Liu L, Chen W, Gong X, Li J, Han X, Meng X, Wang Y. Efficacy and safety of dual antiplatelet therapy in the elderly for stroke prevention: a subgroup analysis of the CHANCE-2 trial. Stroke Vasc Neurol. 2024 Nov 5;9(5):541-550. doi: 10.1136/svn-2023-002450.

    PubMed 38286485

  • Meng X, Wang A, Tian X, Johnston C, Li H, Bath PM, Xu Q, Zhang Y, Xie X, Jing J, Lin J, Wang Y, Zhao X, Li Z, Jiang Y, Liu L, Wang Y. One-Year Outcomes of Early Therapy With Ticagrelor vs Clopidogrel in CYP2C19 Loss-of-Function Carriers With Stroke or TIA Trial. Neurology. 2024 Feb 13;102(3):e207809. doi: 10.1212/WNL.0000000000207809. Epub 2024 Jan 5.

    PubMed 38181311

  • Wang A, Tian X, Xie X, Li H, Jing J, Lin J, Wang Y, Zhao X, Li Z, Liu L, Wang Y, Meng X. Effects of remnant cholesterol on the efficacy of genotype-guided dual antiplatelet in CYP2C19 loss-of -function carriers with minor stroke or transient ischaemic attack: a post-hoc analysis of the CHANCE-2 trial. EClinicalMedicine. 2023 Dec 2;67:102357. doi: 10.1016/j.eclinm.2023.102357. eCollection 2024 Jan.

    PubMed 38125963

  • Wang C, Jia W, Jing J, Meng X, Wang A, Xu Q, Zhang X, Pan Y, Xie X, Johnston SC, Bath PM, Lin J, Jiang Y, Li H, Wang Y, Zhao X, Liu L, Li Z, Wang Y; CHANCE-2 Investigators. Ticagrelor Versus Clopidogrel in Minor Stroke or Transient Ischemic Attack With Intracranial Artery Stenosis: A Post Hoc Analysis of CHANCE-2. J Am Heart Assoc. 2023 Nov 7;12(21):e031611. doi: 10.1161/JAHA.123.031611. Epub 2023 Oct 27.

    PubMed 37889172

  • Xie X, Jing J, Meng X, Claiborne Johnston S, Bath PM, Li Z, Zhao X, Liu L, Wang Y, Xu Q, Wang A, Jiang Y, Li H, Wang Y; CHANCE-2 Investigators. Dual Antiplatelet Therapies and Causes in Minor Stroke or Transient Ischemic Attack: A Prespecified Analysis in the CHANCE-2 Trial. Stroke. 2023 Sep;54(9):2241-2250. doi: 10.1161/STROKEAHA.122.042233. Epub 2023 Aug 7.

    PubMed 37548009

  • Zhang J, Wang A, Tian X, Meng X, Xie X, Jing J, Lin J, Wang Y, Li Z, Liu L, Li H, Jiang Y, Zhao X, Wang Y. Impact of body mass index on efficacy and safety of ticagrelor versus clopidogrel in patients with minor stroke or transient ischemic attack. CMAJ. 2023 Jul 10;195(26):E897-E904. doi: 10.1503/cmaj.230262.

    PubMed 37429630

  • Xie X, Johnston SC, Wang A, Xu Q, Bath PM, Pan Y, Li H, Lin J, Wang Y, Zhao X, Li Z, Jiang Y, Liu L, Xu A, Jing J, Meng X, Wang Y. Association of CYP2C19 Loss-of-Function Metabolizer Status With Stroke Risk Among Chinese Patients Treated With Ticagrelor-Aspirin vs Clopidogrel-Aspirin: A Prespecified Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2317037. doi: 10.1001/jamanetworkopen.2023.17037.

    PubMed 37279000

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ticagrelor and Aspirin and Clopidogrel and Aspirin in people with Stroke and Transient Ischemic Attack, run by Beijing Tiantan Hospital at 214 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 7 inclusion and 32 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 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 214 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. 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 (ischemic stroke or hemorrhagic stroke) within 3 months (time frame: 3 months after randomization). 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 NCT04078737, which also lists 22 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 2 Dec 2021.

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