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Clopidogrel With Aspirin in High-risk Patients With Acute Non-disabling Cerebrovascular Events II (CHANCE-2)

Primary Purpose

Stroke, Transient Ischemic Attack

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Ticagrelor and Aspirin
Clopidogrel and Aspirin
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke focused on measuring 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

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  1. 40 years or older than 40 years；

  2. 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)；
  3. Can be treated with study drug within 24 hours of symptoms onset*(*Symptom onset is defined by the "last seen normal" principle)；
  4. CYP2C19 loss-of-function allele carriers；
  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 minor stroke or TIA.
  4. Preceding moderate or severe dependency (modified Rankin scale [mRS] score 3-5).

  5. Contraindication to clopidogrel, ticagrelor or aspirin

    • Known allergy
    • 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)
  6. Hematocrit (HCT) <30%
  7. Clear indication for anticoagulation (presumed cardiac source of embolus, e.g., atrial fibrillation, prosthetic cardiac valves known or suspected endocarditis)
  8. History of intracranial hemorrhage or amyloid angiopathy
  9. History of aneurysm (including intracranial aneurysm and peripheral aneurysm)
  10. History of asthma or COPD (chronic obstructive pulmonary disease)
  11. High-risk for bradyarrhythmia (first-degree or second-degree AV block caused by sinus node disease, and brady-arrhythmic syncope without pacemaker)
  12. History of hyperuricemia nephropathy
  13. Anticipated requirement for long-term (>7 days) non-steroidal anti-inflammatory drugs (NSAIDs)
  14. Planned or likely revascularization (any angioplasty or vascular surgery) within the next 3 months
  15. Scheduled for surgery or interventional treatment requiring study drug cessation
  16. Severe non-cardiovascular comorbidity with life expectancy < 3 months
  17. Inability to understand and/or follow research procedures due to mental, cognitive, or emotional disorders
  18. Dual antiplatelet treatment (or more than two antiplatelet agents) in 72 hours before randomization
  19. Current treatment (last dose given within 10 days before randomization) with heparin therapy or oral anti coagulation
  20. Intravenous thrombolytic therapy (such as intravenous rtPA) or mechanical thrombectomy within 24 hours prior to randomization
  21. Gastrointestinal bleed within 3 months or major surgery within 30 days
  22. Diagnosis or suspicious diagnosis of acute coronary syndrome
  23. Participation in another clinical study with an experimental product during the last 30 days
  24. Currently receiving an experimental drug or device
  25. Pregnant, currently trying to become pregnant, or of child-bearing potential and not using birth control

Sites / Locations

  • Anqing Municipal Hospital
  • The First Affiliated Hospital of Bengbu Medical College
  • Beijing Chaoyang Hospital, Capital MedicalUniversity（west Hospital）
  • Beijing Tian tan Hospital
  • Beijing Shunyi Airport Hospital
  • The First Hospital of Fangshan District
  • Beijing Coal Group Hospital
  • Peking University Third Hospital
  • Chongqing People's Hospital
  • The Second Affiliated Hospital of Chongqing Medical University
  • Chongqing Sanbo Chang 'an Hospital
  • Daping Hospital of Army Military Medical University
  • The First Affiliated Hospital of Chongqing Medical University
  • Chongqing Fifth People's Hospital
  • The Third Affiliated Hospital of Chongqing Medical University
  • People's Hospital of Rongchang District, Chongqing,
  • Chongqing Three Gorges Central Hospital
  • Chongqing Kaizhou District People's Hospital
  • Chongqing Fuling Central Hospital
  • Chongqing Nanchuan District People's Hospital
  • Xiushan Tujia and Miao Autonomous County People's Hospital
  • The Third Affiliated Hospital of Fujian University of Traditional Chinese Medicine
  • Fuzhou Second Hospital
  • Sanming First Hospital Affiliated to Fujian Medical University
  • Wuwei People's Hospital
  • Zhangye People's Hospital Affiliated to Hexi College
  • Dongguan People's Hospital
  • The Second Affiliated Hospital of Guangzhou Medical University
  • Nanfang Hospital Of Southern Medical University
  • The First Affiliated Hospital of Jinan University
  • The first Affiliated Hospital of Shantou University Medical College
  • Guiyang Second People's Hospital
  • Affiliated Hospital of Guizhou Medical University
  • Hainan West Central Hospital
  • The First Affiliated Hospital of Hainan Medical University
  • Affiliated Hospital of Hebei Medical University
  • Affiliated Hospital of Hebei University
  • The Affiliated Hospital of Chengde Medical College
  • Hejian People's Hospital
  • HaLixun InternationalPeace Hospital
  • Hengshui fourth People Hospital（Department of Neurology ward 2）
  • The Fourth People's Hospital of Hengshui City（Department of Neurology ward 1）
  • The Second Hospitalof Hebei Medical University
  • The First Affiliated Hospital of Hebei North University
  • Second Central Hospital of Baoding
  • Daqing Oilfield Gengeal Hospital
  • Daqing People's Hospital
  • The First Hospital of Harbin Medical University
  • The Second Hospital of Harbin Medical University（Department of Neurology ward 1）
  • The Second Hospital of Harbin Medical University（Department of Neurology ward ）
  • The First Affiliated Hospital of Jiamusi University
  • Hongqi Hospital affiliated to Mudanjiang Medical University
  • Qiqihar Rongjian Institute of Stroke Prevention and Treatment
  • Anyang People's Hospital
  • Changge People's Hospital
  • Xiuwu County People's Hospital
  • Jiyuan People's Hospital
  • Kaifeng Central Hospital
  • weishi county Central Hospital
  • Luohe Central Hospital
  • Luoyang Central Hospital
  • The first Affiliated Hospital of Henan University of Science and Technology
  • The Second Affiliated Hospital of Henan University of Science and Technology
  • Luoyang New District People's Hospital
  • Pingdingshan First People's Hospital
  • Sanmenxia Central Hospital
  • Shangqiu Fourth People's Hospital
  • Suixian county Hospital of Traditional Chinese Medicine
  • Xingyang People's Hospital
  • The first Affiliated Hospital of Xinxiang Medical University
  • The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
  • Gongyi People's Hospital
  • Zhoukou Yongshan Hospital
  • Zhumadian Hospital of Traditional Chinese Medicine
  • Wuhan No.1 Hospital
  • The Central Hospital of Wuhan
  • First hospital of Changsha city
  • Chenzhou First People's Hospital
  • Fourth People's Hospital of Chenzhou
  • The First Affiliated Hospital of Nanhua University
  • Loudi City Central Hospital
  • shaoyang Central Hospital
  • Xiangtan Central Hospital
  • Yueyang Second People's Hospital
  • The first Affiliated Hospital of Baotou Medical College
  • Baotou CentralHospital
  • The second Affiliated Hospital of Baotou Medical College
  • Wuyuan County People's Hospital
  • Hulun Buir People's Hospital
  • Chifeng City Hospital
  • Affiliated Hospital of Chifeng University
  • Inner Mongolia People's Hospital
  • Inner Mongolia International Mongolian Hospital
  • Shangrao City People's Hospital
  • Huaian Hospital of Traditional Chinese Medicine
  • Lianshui County People's Hospital
  • The Second People's Hospital of Lianyungang
  • Nanjing Jiangning Hospital
  • The Second Affiliated Hospital of Nanjing Medical University
  • Nanjing Gulou Hospital
  • BenQ Hospital affiliated to Nanjing Medical University
  • Jiangsu Provincial Hospital of Traditional Chinese Medicine
  • Nanjing Brain Hospital
  • The Fourth Affiliated Hospital of Nanjing Medical University
  • Nanjing Jiangbei People's Hospital
  • Nanjing Gaochun People's Hospital
  • Nantong 6th People's Hospital
  • Nantong Hospital of Traditional Chinese Medicine
  • The Third People's Hospital in Tongzhou District, Nantong
  • Affiliated Hospital of Nantong University
  • Nantong First People's Hospital
  • Nantong Second People's Hospital
  • Nantong Fourth People's Hospital
  • Nantong Third People's Hospital
  • Tongzhou District People's Hospital of Nantong City
  • Rudong County People's Hospital
  • Rugao People's Hospital
  • Hai 'an People's Hospital
  • Tongzhou District 8th People's Hospital of Nantong City
  • Siyang County People's Hospital
  • Siyang Kangda Hospital
  • Suqian People's Hospital
  • Suzhou Municipal Hospital
  • The Second Affiliated Hospital of Soochow University
  • Taizhou People's Hospital
  • Xinghua People's Hospital
  • Wuxi People's Hospital
  • Affiliated Hospital of Jiangnan University
  • Yixing People's Hospital
  • Jiangyin People's Hospital
  • xuzhou Central Hospital
  • Xuzhou coal mining group General Hospital
  • Affiliated Hospital of Xuzhou Medical University（Department of Neurology ward 1）
  • Affiliated Hospital of Xuzhou Medical University（Department of Neurology ward 2）
  • Subei People's Hospital of Jiangsu province
  • Affiliated Hospital of Yangzhou University
  • The fourth peoples hospital of zhenjiang city
  • Ganzhou city people's Hospital
  • The First People's Hospital of Jingdehzne City
  • Affiliated Hospital of Jiujiang College
  • Jiujiang first people's Hospital
  • First Affiliated Hospital of Nanchang University
  • Jiangxi Provincial People's Hospital
  • Sino-Japanese Friendship Hospital Of Jilin University
  • The First Hospital Of Jilin University
  • Jilin Provincial People's Hospital
  • Xinhua Hospital affiliated to Dalian University
  • Second People's Hospital of Huludao City
  • Shengjing Hospital of China Medical University
  • First People's Hospital of Shenyang
  • Guyuan people's hospital
  • The Fifth People's Hospital of Ningxia Hui Autonomous Region
  • The Second People's Hospital of Shizuishan
  • Shizuishan First People's Hospital
  • Second people's Hospital of shizuishan
  • General Hospital of Ningxia Medical University
  • Yinchuan First People's Hospital
  • Cardiovascular and Cerebrovoscular Hospital of General Hospital of Ningxia Med. Univ
  • People's Hospital of Ningxia Hui Autonomous Region
  • Zhongwei People's Hospital
  • Baoji High-tech People's Hospital
  • weinan Central Hospital
  • Xi 'an Hi-tech Hospital
  • Xi 'an Fengcheng Hospital
  • Xian 141 Hospital
  • Dezhou People's Hospital
  • Ningjin County People's Hospital
  • Shandong Provincial Hospital
  • Liaocheng City Third People's Hospital
  • Liaocheng People's Hospital
  • Liaocheng Veterans Hospital
  • The Brain Hospital of Liaocheng People's Hospital
  • Guanxian People's Hospital
  • Liaocheng City Second People's Hospital
  • Dongchangfu people's Hospital
  • Liaocheng Central Hospital
  • Linqing People's Hospital
  • Qingdao Municipal Hospital
  • Affiliated Hospital of Qingdao University Medical College
  • Qingdao West Coast New Area People's Hospital
  • Affiliated Hospital of Weifang Medical University
  • Sunshine Union Hospital
  • weihai Central Hospital
  • Wendeng District People's Hospital
  • Penglai People's Hospital
  • Yantai Beihai Hospita
  • Putuo District Central Hospital
  • Shanghai 7th People's Hospital
  • Changzhi People's Hospital
  • Heping Hospital affiliated to Changzhi Medical College
  • Datong Fifth People's Hospital
  • The Third People's Hospital of Datong
  • Shanxi cardiovascular disease hospital
  • Shanxi Bethune Hospital
  • Taiyuan Iron and Steel (Group) Co, Ltd,General Hospital
  • The First Hospital of Shanxi Medical University
  • Xi 'an First Hospital
  • Shenzhen Integrated Chinese and Western Medicine Hospital
  • Shenzhen Luohu People's Hospital
  • Shenzhen Second People's Hospital
  • Huazhong University of Science and Technology Union Shenzhen Hospital
  • West China Hospital Of Sichuan University
  • Chengdu second Municipal People'sHospital
  • Sichuan Provincial People's Hospital
  • dazhou Central Hospital
  • Tianjin Medical University General Hospital
  • First Affiliated Hospital of Xinjiang Medical University
  • People's Hospital Of Xinjiang Uygur Autonomous Region
  • Friendship Hospital of Ili Kazak Autonomous Prefecture
  • First People's Hospital of Yunnan Province
  • Hangzhou first people's Hospital
  • lishui municipal Central Hospital
  • Zhejiang Wenzhou Medical College Third Affiliated Hospital
  • Taizhou First People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ticagrelor plus Aspirin Group

Clopidogrel plus Aspirin Group

Arm Description

Ticagrelor 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

Clopidogrel 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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)
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.
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).
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).
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).
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.
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.

Full Information

First Posted
July 8, 2019
Last Updated
November 30, 2021
Sponsor
Beijing Tiantan Hospital
Collaborators
Ministry of Science and Technology of the People´s Republic of China
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1. Study Identification

Unique Protocol Identification Number
NCT04078737
Brief Title
Clopidogrel With Aspirin in High-risk Patients With Acute Non-disabling Cerebrovascular Events II
Acronym
CHANCE-2
Official Title
Clopidogrel With Aspirin in High-risk Patients With Acute Non-disabling Cerebrovascular Events II
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
September 23, 2019 (Actual)
Primary Completion Date
June 24, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital
Collaborators
Ministry of Science and Technology of the People´s Republic of China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Transient Ischemic Attack
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation
Randomized
Enrollment
6412 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ticagrelor plus Aspirin Group
Arm Type
Experimental
Arm Description
Ticagrelor 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
Arm Title
Clopidogrel plus Aspirin Group
Arm Type
Active Comparator
Arm Description
Clopidogrel 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
Intervention Type
Drug
Intervention Name(s)
Ticagrelor and Aspirin
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Clopidogrel and Aspirin
Intervention Description
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
Primary Outcome Measure Information:
Title
Any new stroke events (ischemic stroke or hemorrhagic stroke) within 3 months
Description
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.
Time Frame
3 months after randomization
Secondary Outcome Measure Information:
Title
Any new stroke events within 30 days and 1 year
Description
Percentage of patients with the 30 days and 1 year new stroke events (ischemic stroke/ hemorrhagic stroke) as a cluster and evaluated individually.
Time Frame
30 days and 1 year after randomization
Title
New clinical vascular events including stroke, TIA, myocardial infarction, and vascular deaths within 3 months and 1 year
Description
Percentage of patients with the 3 months and 1 year new clinical vascular events (ischemic stroke/ hemorrhagic stroke/ TIA/ myocardial infarction/vascular death)
Time Frame
3 months and 1 year after randomization
Title
New ischemic stroke within 3 months and 1 year
Description
Percentage of patients with the 3 months and 1 year new ischemic stroke will be evaluated.
Time Frame
3 months and 1 year after randomization
Title
Disabling stroke (Modified Rankin Scale score, mRS>1) at 3 months and 1 year
Description
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).
Time Frame
3 months and 1 year after randomization
Title
Incidence and severity of recurrent stroke and TIA during follow-up to 3 months and 1-year
Description
(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).
Time Frame
3 months and 1 year after randomization
Title
Neurological impairment at 3 months (NIHSS increased≥4 from baseline)
Description
The National Institutes of Health Stroke Scale (NIHSS) score classifies neurologic deficit from 0 (no deficit) to 42 (most severe).
Time Frame
3 months after randomization
Title
Quality of Life (EuroQol EQ-5D scale) at 3 months and at 1 year
Description
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.
Time Frame
3 months and 1 year after randomization
Title
Stratified analysis
Description
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.
Time Frame
3 months and 1 year after randomization
Other Pre-specified Outcome Measures:
Title
Moderate and severe bleeding events according to the GUSTO criteria
Description
Severe bleeding incidence (GUSTO definition), including fatal bleeding and symptomatic intracranial hemorrhage.
Time Frame
3 months after randomization
Title
Moderate and severe bleeding events according to the GUSTO criteria
Description
Severe bleeding incidence (GUSTO definition), including fatal bleeding and symptomatic intracranial hemorrhage.
Time Frame
1 year after randomization
Title
All bleeding events
Description
All bleeding events (severe/moderate bleeding and intracranial hemorrhage)
Time Frame
3 months and 1 year after randomization
Title
Total mortality
Description
Total mortality
Time Frame
3 months and 1 year after randomization
Title
Incidence symptomatic intracranial hemorrhagic events
Description
Incidence symptomatic intracranial hemorrhagic events
Time Frame
3 months and 1 year after randomization
Title
Adverse events
Description
Adverse events
Time Frame
3 months and 1 year after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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. Exclusion Criteria 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongjun Wang, M.D
Organizational Affiliation
Beijing Tian Tan Hospital, Capital Medical University, Beijing, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anqing Municipal Hospital
City
Anqing
State/Province
Anhui
ZIP/Postal Code
246003
Country
China
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
ZIP/Postal Code
233004
Country
China
Facility Name
Beijing Chaoyang Hospital, Capital MedicalUniversity（west Hospital）
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100043
Country
China
Facility Name
Beijing Tian tan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100070
Country
China
Facility Name
Beijing Shunyi Airport Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101318
Country
China
Facility Name
The First Hospital of Fangshan District
City
Beijing
State/Province
Beijing
ZIP/Postal Code
102488
Country
China
Facility Name
Beijing Coal Group Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Chongqing People's Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400010
Country
China
Facility Name
The Second Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400010
Country
China
Facility Name
Chongqing Sanbo Chang 'an Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400023
Country
China
Facility Name
Daping Hospital of Army Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400060
Country
China
Facility Name
Chongqing Fifth People's Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400062
Country
China
Facility Name
The Third Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
401120
Country
China
Facility Name
People's Hospital of Rongchang District, Chongqing,
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
402460
Country
China
Facility Name
Chongqing Three Gorges Central Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
404000
Country
China
Facility Name
Chongqing Kaizhou District People's Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
405400
Country
China
Facility Name
Chongqing Fuling Central Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
408000
Country
China
Facility Name
Chongqing Nanchuan District People's Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
408400
Country
China
Facility Name
Xiushan Tujia and Miao Autonomous County People's Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
409900
Country
China
Facility Name
The Third Affiliated Hospital of Fujian University of Traditional Chinese Medicine
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China
Facility Name
Fuzhou Second Hospital
City
Fuzhou
State/Province
Fujian
Country
China
Facility Name
Sanming First Hospital Affiliated to Fujian Medical University
City
Sanming
State/Province
Fujian
ZIP/Postal Code
100043
Country
China
Facility Name
Wuwei People's Hospital
City
Wuwei
State/Province
Gansu
ZIP/Postal Code
733000
Country
China
Facility Name
Zhangye People's Hospital Affiliated to Hexi College
City
Zhangye
State/Province
Gansu
ZIP/Postal Code
734000
Country
China
Facility Name
Dongguan People's Hospital
City
Dongguan
State/Province
Guangdong
ZIP/Postal Code
523000
Country
China
Facility Name
The Second Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510260
Country
China
Facility Name
Nanfang Hospital Of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
The First Affiliated Hospital of Jinan University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510632
Country
China
Facility Name
The first Affiliated Hospital of Shantou University Medical College
City
Shantou
State/Province
Guangdong
ZIP/Postal Code
515041
Country
China
Facility Name
Guiyang Second People's Hospital
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550000
Country
China
Facility Name
Affiliated Hospital of Guizhou Medical University
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550004
Country
China
Facility Name
Hainan West Central Hospital
City
Danzhou
State/Province
Hainan
ZIP/Postal Code
571799
Country
China
Facility Name
The First Affiliated Hospital of Hainan Medical University
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570102
Country
China
Facility Name
Affiliated Hospital of Hebei Medical University
City
Baoding
State/Province
Hebei
ZIP/Postal Code
071000
Country
China
Facility Name
Affiliated Hospital of Hebei University
City
Baoding
State/Province
Hebei
ZIP/Postal Code
071000
Country
China
Facility Name
The Affiliated Hospital of Chengde Medical College
City
Chengde
State/Province
Hebei
ZIP/Postal Code
067000
Country
China
Facility Name
Hejian People's Hospital
City
Hejian
State/Province
Hebei
ZIP/Postal Code
062450
Country
China
Facility Name
HaLixun InternationalPeace Hospital
City
Hengshui
State/Province
Hebei
ZIP/Postal Code
053000
Country
China
Facility Name
Hengshui fourth People Hospital（Department of Neurology ward 2）
City
Hengshui
State/Province
Hebei
ZIP/Postal Code
053000
Country
China
Facility Name
The Fourth People's Hospital of Hengshui City（Department of Neurology ward 1）
City
Hengshui
State/Province
Hebei
ZIP/Postal Code
053000
Country
China
Facility Name
The Second Hospitalof Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Facility Name
The First Affiliated Hospital of Hebei North University
City
Zhangjiakou
State/Province
Hebei
ZIP/Postal Code
75000
Country
China
Facility Name
Second Central Hospital of Baoding
City
Zhuozhou
State/Province
Hebei
ZIP/Postal Code
072750
Country
China
Facility Name
Daqing Oilfield Gengeal Hospital
City
Daqing
State/Province
Heilongjiang
ZIP/Postal Code
163001
Country
China
Facility Name
Daqing People's Hospital
City
Daqing
State/Province
Heilongjiang
ZIP/Postal Code
163361
Country
China
Facility Name
The First Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Facility Name
The Second Hospital of Harbin Medical University（Department of Neurology ward 1）
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150086
Country
China
Facility Name
The Second Hospital of Harbin Medical University（Department of Neurology ward ）
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150086
Country
China
Facility Name
The First Affiliated Hospital of Jiamusi University
City
Jiamusi
State/Province
Heilongjiang
ZIP/Postal Code
154002
Country
China
Facility Name
Hongqi Hospital affiliated to Mudanjiang Medical University
City
Mudanjiang
State/Province
Heilongjiang
ZIP/Postal Code
157000
Country
China
Facility Name
Qiqihar Rongjian Institute of Stroke Prevention and Treatment
City
Qiqihar
State/Province
Heilongjiang
Country
China
Facility Name
Anyang People's Hospital
City
Anyang
State/Province
Henan
ZIP/Postal Code
455000
Country
China
Facility Name
Changge People's Hospital
City
Changge
State/Province
Henan
ZIP/Postal Code
461500
Country
China
Facility Name
Xiuwu County People's Hospital
City
Jiaozuo
State/Province
Henan
ZIP/Postal Code
454350
Country
China
Facility Name
Jiyuan People's Hospital
City
Jiyuan
State/Province
Henan
ZIP/Postal Code
459000
Country
China
Facility Name
Kaifeng Central Hospital
City
Kaifeng
State/Province
Henan
ZIP/Postal Code
475000
Country
China
Facility Name
weishi county Central Hospital
City
Kaifeng
State/Province
Henan
ZIP/Postal Code
475500
Country
China
Facility Name
Luohe Central Hospital
City
Luohe
State/Province
Henan
ZIP/Postal Code
462000
Country
China
Facility Name
Luoyang Central Hospital
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471000
Country
China
Facility Name
The first Affiliated Hospital of Henan University of Science and Technology
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471000
Country
China
Facility Name
The Second Affiliated Hospital of Henan University of Science and Technology
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471000
Country
China
Facility Name
Luoyang New District People's Hospital
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471023
Country
China
Facility Name
Pingdingshan First People's Hospital
City
Pingdingshan
State/Province
Henan
ZIP/Postal Code
467000
Country
China
Facility Name
Sanmenxia Central Hospital
City
Sanmenxia
State/Province
Henan
ZIP/Postal Code
472000
Country
China
Facility Name
Shangqiu Fourth People's Hospital
City
Shangqiu
State/Province
Henan
ZIP/Postal Code
476000
Country
China
Facility Name
Suixian county Hospital of Traditional Chinese Medicine
City
Shangqiu
State/Province
Henan
ZIP/Postal Code
476900
Country
China
Facility Name
Xingyang People's Hospital
City
Xingyang
State/Province
Henan
ZIP/Postal Code
450100
Country
China
Facility Name
The first Affiliated Hospital of Xinxiang Medical University
City
Xinxiang
State/Province
Henan
ZIP/Postal Code
453100
Country
China
Facility Name
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Facility Name
Gongyi People's Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
451200
Country
China
Facility Name
Zhoukou Yongshan Hospital
City
Zhoukou
State/Province
Henan
ZIP/Postal Code
461300
Country
China
Facility Name
Zhumadian Hospital of Traditional Chinese Medicine
City
Zhumadian
State/Province
Henan
ZIP/Postal Code
463000
Country
China
Facility Name
Wuhan No.1 Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Facility Name
The Central Hospital of Wuhan
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430014
Country
China
Facility Name
First hospital of Changsha city
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410005
Country
China
Facility Name
Chenzhou First People's Hospital
City
Chenzhou
State/Province
Hunan
ZIP/Postal Code
423000
Country
China
Facility Name
Fourth People's Hospital of Chenzhou
City
Chenzhou
State/Province
Hunan
ZIP/Postal Code
423000
Country
China
Facility Name
The First Affiliated Hospital of Nanhua University
City
Hengyang
State/Province
Hunan
ZIP/Postal Code
421001
Country
China
Facility Name
Loudi City Central Hospital
City
Loudi
State/Province
Hunan
ZIP/Postal Code
417000
Country
China
Facility Name
shaoyang Central Hospital
City
Shaoyang
State/Province
Hunan
Country
China
Facility Name
Xiangtan Central Hospital
City
Xiangtan
State/Province
Hunan
ZIP/Postal Code
411100
Country
China
Facility Name
Yueyang Second People's Hospital
City
Yueyang
State/Province
Hunan
ZIP/Postal Code
414000
Country
China
Facility Name
The first Affiliated Hospital of Baotou Medical College
City
Baotou
State/Province
Inner Mongolia Autonomous Region
ZIP/Postal Code
014010
Country
China
Facility Name
Baotou CentralHospital
City
Baotou
State/Province
Inner Mongolia Autonomous Region
ZIP/Postal Code
014040
Country
China
Facility Name
The second Affiliated Hospital of Baotou Medical College
City
Baotou
State/Province
Inner Mongolia Autonomous Region
ZIP/Postal Code
14030
Country
China
Facility Name
Wuyuan County People's Hospital
City
Bayan Nur
State/Province
Inner Mongolia Autonomous Region
ZIP/Postal Code
15100
Country
China
Facility Name
Hulun Buir People's Hospital
City
Buri
State/Province
Inner Mongolia Autonomous Region
ZIP/Postal Code
21000
Country
China
Facility Name
Chifeng City Hospital
City
Chifeng
State/Province
Inner Mongolia Autonomous Region
ZIP/Postal Code
024000
Country
China
Facility Name
Affiliated Hospital of Chifeng University
City
Chifeng
State/Province
Inner Mongolia Autonomous Region
ZIP/Postal Code
024005
Country
China
Facility Name
Inner Mongolia People's Hospital
City
Hohhot
State/Province
Inner Mongolia Autonomous Region
ZIP/Postal Code
010017
Country
China
Facility Name
Inner Mongolia International Mongolian Hospital
City
Hohhot
State/Province
Inner Mongolia Autonomous Region
ZIP/Postal Code
010069
Country
China
Facility Name
Shangrao City People's Hospital
City
Shangrao
State/Province
Jiang XI
Country
China
Facility Name
Huaian Hospital of Traditional Chinese Medicine
City
Huai'an
State/Province
Jiangsu
ZIP/Postal Code
223001
Country
China
Facility Name
Lianshui County People's Hospital
City
Huai'an
State/Province
Jiangsu
ZIP/Postal Code
223400
Country
China
Facility Name
The Second People's Hospital of Lianyungang
City
Lianyungang
State/Province
Jiangsu
ZIP/Postal Code
222023
Country
China
Facility Name
Nanjing Jiangning Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Facility Name
The Second Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210003
Country
China
Facility Name
Nanjing Gulou Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Facility Name
BenQ Hospital affiliated to Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210019
Country
China
Facility Name
Jiangsu Provincial Hospital of Traditional Chinese Medicine
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Nanjing Brain Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
The Fourth Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210031
Country
China
Facility Name
Nanjing Jiangbei People's Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210048
Country
China
Facility Name
Nanjing Gaochun People's Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
211300
Country
China
Facility Name
Nantong 6th People's Hospital
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226000
Country
China
Facility Name
Nantong Hospital of Traditional Chinese Medicine
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226000
Country
China
Facility Name
The Third People's Hospital in Tongzhou District, Nantong
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226000
Country
China
Facility Name
Affiliated Hospital of Nantong University
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226001
Country
China
Facility Name
Nantong First People's Hospital
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226001
Country
China
Facility Name
Nantong Second People's Hospital
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226002
Country
China
Facility Name
Nantong Fourth People's Hospital
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226005
Country
China
Facility Name
Nantong Third People's Hospital
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
22600
Country
China
Facility Name
Tongzhou District People's Hospital of Nantong City
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226300
Country
China
Facility Name
Rudong County People's Hospital
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226400
Country
China
Facility Name
Rugao People's Hospital
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226500
Country
China
Facility Name
Hai 'an People's Hospital
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226600
Country
China
Facility Name
Tongzhou District 8th People's Hospital of Nantong City
City
Nantong
State/Province
Jiangsu
Country
China
Facility Name
Siyang County People's Hospital
City
Suqian
State/Province
Jiangsu
ZIP/Postal Code
223700
Country
China
Facility Name
Siyang Kangda Hospital
City
Suqian
State/Province
Jiangsu
ZIP/Postal Code
223700
Country
China
Facility Name
Suqian People's Hospital
City
Suqian
State/Province
Jiangsu
ZIP/Postal Code
223800
Country
China
Facility Name
Suzhou Municipal Hospital
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215000
Country
China
Facility Name
The Second Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215004
Country
China
Facility Name
Taizhou People's Hospital
City
Taizhou
State/Province
Jiangsu
ZIP/Postal Code
225300
Country
China
Facility Name
Xinghua People's Hospital
City
Taizhou
State/Province
Jiangsu
ZIP/Postal Code
225700
Country
China
Facility Name
Wuxi People's Hospital
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214000
Country
China
Facility Name
Affiliated Hospital of Jiangnan University
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214041
Country
China
Facility Name
Yixing People's Hospital
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214200
Country
China
Facility Name
Jiangyin People's Hospital
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214400
Country
China
Facility Name
xuzhou Central Hospital
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221000
Country
China
Facility Name
Xuzhou coal mining group General Hospital
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221000
Country
China
Facility Name
Affiliated Hospital of Xuzhou Medical University（Department of Neurology ward 1）
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221002
Country
China
Facility Name
Affiliated Hospital of Xuzhou Medical University（Department of Neurology ward 2）
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221002
Country
China
Facility Name
Subei People's Hospital of Jiangsu province
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225009
Country
China
Facility Name
Affiliated Hospital of Yangzhou University
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225012
Country
China
Facility Name
The fourth peoples hospital of zhenjiang city
City
Zhenjiang
State/Province
Jiangsu
ZIP/Postal Code
212001
Country
China
Facility Name
Ganzhou city people's Hospital
City
Ganzhou
State/Province
Jiangxi
ZIP/Postal Code
341000
Country
China
Facility Name
The First People's Hospital of Jingdehzne City
City
Jingdezhen
State/Province
Jiangxi
ZIP/Postal Code
333000
Country
China
Facility Name
Affiliated Hospital of Jiujiang College
City
Jiujiang
State/Province
Jiangxi
ZIP/Postal Code
332000
Country
China
Facility Name
Jiujiang first people's Hospital
City
Jiujiang
State/Province
Jiangxi
ZIP/Postal Code
332000
Country
China
Facility Name
First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330000
Country
China
Facility Name
Jiangxi Provincial People's Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Sino-Japanese Friendship Hospital Of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130031
Country
China
Facility Name
The First Hospital Of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130031
Country
China
Facility Name
Jilin Provincial People's Hospital
City
Changchun
State/Province
Jilin
Country
China
Facility Name
Xinhua Hospital affiliated to Dalian University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116023
Country
China
Facility Name
Second People's Hospital of Huludao City
City
Huludao
State/Province
Liaoning
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Facility Name
First People's Hospital of Shenyang
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110041
Country
China
Facility Name
Guyuan people's hospital
City
Guyuan
State/Province
Ningxia Hui Autonomous Region
ZIP/Postal Code
756000
Country
China
Facility Name
The Fifth People's Hospital of Ningxia Hui Autonomous Region
City
Shizuishan
State/Province
Ningxia Hui Autonomous Region
ZIP/Postal Code
753000
Country
China
Facility Name
The Second People's Hospital of Shizuishan
City
Shizuishan
State/Province
Ningxia Hui Autonomous Region
ZIP/Postal Code
753000
Country
China
Facility Name
Shizuishan First People's Hospital
City
Shizuishan
State/Province
Ningxia Hui Autonomous Region
ZIP/Postal Code
753200
Country
China
Facility Name
Second people's Hospital of shizuishan
City
Shizuishan
State/Province
Ningxia Hui Autonomous Region
ZIP/Postal Code
753400
Country
China
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia Hui Autonomous Region
ZIP/Postal Code
750001
Country
China
Facility Name
Yinchuan First People's Hospital
City
Yinchuan
State/Province
Ningxia Hui Autonomous Region
ZIP/Postal Code
750001
Country
China
Facility Name
Cardiovascular and Cerebrovoscular Hospital of General Hospital of Ningxia Med. Univ
City
Yinchuan
State/Province
Ningxia Hui Autonomous Region
ZIP/Postal Code
750002
Country
China
Facility Name
People's Hospital of Ningxia Hui Autonomous Region
City
Yinchuan
State/Province
Ningxia Hui Autonomous Region
ZIP/Postal Code
750002
Country
China
Facility Name
Zhongwei People's Hospital
City
Zhongwei
State/Province
Ningxia Hui Autonomous Region
ZIP/Postal Code
755000
Country
China
Facility Name
Baoji High-tech People's Hospital
City
Baoji
State/Province
Shaanxi
ZIP/Postal Code
721000
Country
China
Facility Name
weinan Central Hospital
City
Weinan
State/Province
Shaanxi
ZIP/Postal Code
714000
Country
China
Facility Name
Xi 'an Hi-tech Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710000
Country
China
Facility Name
Xi 'an Fengcheng Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710016
Country
China
Facility Name
Xian 141 Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710089
Country
China
Facility Name
Dezhou People's Hospital
City
Dezhou
State/Province
Shandong
ZIP/Postal Code
2530000
Country
China
Facility Name
Ningjin County People's Hospital
City
Dezhou
State/Province
Shandong
ZIP/Postal Code
253400
Country
China
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250021
Country
China
Facility Name
Liaocheng City Third People's Hospital
City
Liaocheng
State/Province
Shandong
ZIP/Postal Code
252000
Country
China
Facility Name
Liaocheng People's Hospital
City
Liaocheng
State/Province
Shandong
ZIP/Postal Code
252000
Country
China
Facility Name
Liaocheng Veterans Hospital
City
Liaocheng
State/Province
Shandong
ZIP/Postal Code
252000
Country
China
Facility Name
The Brain Hospital of Liaocheng People's Hospital
City
Liaocheng
State/Province
Shandong
ZIP/Postal Code
252000
Country
China
Facility Name
Guanxian People's Hospital
City
LiaoCheng
State/Province
Shandong
ZIP/Postal Code
252500
Country
China
Facility Name
Liaocheng City Second People's Hospital
City
Liaocheng
State/Province
Shandong
ZIP/Postal Code
252601
Country
China
Facility Name
Dongchangfu people's Hospital
City
Liaocheng
State/Province
Shandong
Country
China
Facility Name
Liaocheng Central Hospital
City
Liaocheng
State/Province
Shandong
Country
China
Facility Name
Linqing People's Hospital
City
Linqing
State/Province
Shandong
ZIP/Postal Code
252600
Country
China
Facility Name
Qingdao Municipal Hospital
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266000
Country
China
Facility Name
Affiliated Hospital of Qingdao University Medical College
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266071
Country
China
Facility Name
Qingdao West Coast New Area People's Hospital
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266400
Country
China
Facility Name
Affiliated Hospital of Weifang Medical University
City
Weifang
State/Province
Shandong
Country
China
Facility Name
Sunshine Union Hospital
City
Weifang
State/Province
Shandong
Country
China
Facility Name
weihai Central Hospital
City
Weihai
State/Province
Shandong
ZIP/Postal Code
264400
Country
China
Facility Name
Wendeng District People's Hospital
City
Weihai
State/Province
Shandong
ZIP/Postal Code
264400
Country
China
Facility Name
Penglai People's Hospital
City
Yantai
State/Province
Shandong
ZIP/Postal Code
265600
Country
China
Facility Name
Yantai Beihai Hospita
City
Yantai
State/Province
Shandong
ZIP/Postal Code
265701
Country
China
Facility Name
Putuo District Central Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200062
Country
China
Facility Name
Shanghai 7th People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200137
Country
China
Facility Name
Changzhi People's Hospital
City
Changzhi
State/Province
Shanxi
ZIP/Postal Code
046000
Country
China
Facility Name
Heping Hospital affiliated to Changzhi Medical College
City
Changzhi
State/Province
Shanxi
ZIP/Postal Code
046000
Country
China
Facility Name
Datong Fifth People's Hospital
City
Datong
State/Province
Shanxi
ZIP/Postal Code
037000
Country
China
Facility Name
The Third People's Hospital of Datong
City
Datong
State/Province
Shanxi
ZIP/Postal Code
037008
Country
China
Facility Name
Shanxi cardiovascular disease hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030024
Country
China
Facility Name
Shanxi Bethune Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
30000
Country
China
Facility Name
Taiyuan Iron and Steel (Group) Co, Ltd,General Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
30001
Country
China
Facility Name
The First Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
Country
China
Facility Name
Xi 'an First Hospital
City
Xi'an
State/Province
Shanxi
Country
China
Facility Name
Shenzhen Integrated Chinese and Western Medicine Hospital
City
Shenzhen
State/Province
Shenzhen
ZIP/Postal Code
100191
Country
China
Facility Name
Shenzhen Luohu People's Hospital
City
Shenzhen
State/Province
Shenzhen
ZIP/Postal Code
518001
Country
China
Facility Name
Shenzhen Second People's Hospital
City
Shenzhen
State/Province
Shenzhen
ZIP/Postal Code
518035
Country
China
Facility Name
Huazhong University of Science and Technology Union Shenzhen Hospital
City
Shenzhen
State/Province
Shenzhen
ZIP/Postal Code
518052
Country
China
Facility Name
West China Hospital Of Sichuan University
City
Chengdou
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Chengdu second Municipal People'sHospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
Facility Name
Sichuan Provincial People's Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610072
Country
China
Facility Name
dazhou Central Hospital
City
Dazhou
State/Province
Sichuan
ZIP/Postal Code
635099
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
First Affiliated Hospital of Xinjiang Medical University
City
Guiyang
State/Province
Xinjiang Autonomous Region
ZIP/Postal Code
8300054
Country
China
Facility Name
People's Hospital Of Xinjiang Uygur Autonomous Region
City
Urumqi
State/Province
Xinjiang Autonomous Region
ZIP/Postal Code
830001
Country
China
Facility Name
Friendship Hospital of Ili Kazak Autonomous Prefecture
City
Yining
State/Province
Xinjiang Autonomous Region
ZIP/Postal Code
835000
Country
China
Facility Name
First People's Hospital of Yunnan Province
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650000
Country
China
Facility Name
Hangzhou first people's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Facility Name
lishui municipal Central Hospital
City
Lishui
State/Province
Zhejiang
ZIP/Postal Code
323000
Country
China
Facility Name
Zhejiang Wenzhou Medical College Third Affiliated Hospital
City
Ruian
State/Province
Zhejiang
ZIP/Postal Code
325200
Country
China
Facility Name
Taizhou First People's Hospital
City
Taizhou
State/Province
Zhejiang
ZIP/Postal Code
318020
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36315949
Citation
Wang A, Xie X, Tian X, Johnston SC, Li H, Bath PM, Zuo Y, Jing J, Lin J, Wang Y, Zhao X, Li Z, Jiang Y, Liu L, Meng X, Wang Y. Ticagrelor-Aspirin Versus Clopidogrel-Aspirin Among CYP2C19 Loss-of-Function Carriers With Minor Stroke or Transient Ischemic Attack in Relation to Renal Function: A Post Hoc Analysis of the CHANCE-2 Trial. Ann Intern Med. 2022 Nov;175(11):1534-1542. doi: 10.7326/M22-1667. Epub 2022 Nov 1.
Results Reference
derived
PubMed Identifier
35656824
Citation
Wang A, Meng X, Tian X, Johnston SC, Li H, Bath PM, Zuo Y, Xie X, Jing J, Lin J, Wang Y, Zhao X, Li Z, Jiang Y, Liu L, Wang F, Wang Y, Huang P, Chen G, Wang Y; CHANCE-2 Investigators. Effect of Hypertension on Efficacy and Safety of Ticagrelor-Aspirin Versus Clopidogrel-Aspirin in Minor Stroke or Transient Ischemic Attack. Stroke. 2022 Sep;53(9):2799-2808. doi: 10.1161/STROKEAHA.122.038662. Epub 2022 Jun 3.
Results Reference
derived
PubMed Identifier
34708996
Citation
Wang Y, Meng X, Wang A, Xie X, Pan Y, Johnston SC, Li H, Bath PM, Dong Q, Xu A, Jing J, Lin J, Niu S, Wang Y, Zhao X, Li Z, Jiang Y, Li W, Liu L, Xu J, Chang L, Wang L, Zhuang X, Zhao J, Feng Y, Man H, Li G, Wang B; CHANCE-2 Investigators. Ticagrelor versus Clopidogrel in CYP2C19 Loss-of-Function Carriers with Stroke or TIA. N Engl J Med. 2021 Dec 30;385(27):2520-2530. doi: 10.1056/NEJMoa2111749. Epub 2021 Oct 28.
Results Reference
derived
PubMed Identifier
33952670
Citation
Wang Y, Johnston C, Bath PM, Meng X, Jing J, Xie X, Wang A, Pan Y, Xu A, Dong Q, Wang Y, Zhao X, Li Z, Li H; CHANCE-2 Investigators. Clopidogrel with aspirin in High-risk patients with Acute Non-disabling Cerebrovascular Events II (CHANCE-2): rationale and design of a multicentre randomised trial. Stroke Vasc Neurol. 2021 Jun;6(2):280-285. doi: 10.1136/svn-2020-000791. Epub 2021 May 5.
Results Reference
derived

Learn more about this trial

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

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