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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04078737
Other study ID # 2017ZX09304018001
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 23, 2019
Est. completion date July 1, 2021

Study information

Verified date November 2021
Source Beijing Tiantan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Other known NCT identifiers
  • NCT04952311

Recruitment information / eligibility

Status Completed
Enrollment 6412
Est. completion date July 1, 2021
Est. primary completion date June 24, 2021
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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

Study Design


Intervention

Drug:
Ticagrelor and Aspirin
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 Aspirin
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

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Beijing Tiantan Hospital Ministry of Science and Technology of the People´s Republic of China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Moderate and severe bleeding events according to the GUSTO criteria Severe bleeding incidence (GUSTO definition), including fatal bleeding and symptomatic intracranial hemorrhage. 3 months after randomization
Other Moderate and severe bleeding events according to the GUSTO criteria Severe bleeding incidence (GUSTO definition), including fatal bleeding and symptomatic intracranial hemorrhage. 1 year after randomization
Other All bleeding events All bleeding events (severe/moderate bleeding and intracranial hemorrhage) 3 months and 1 year after randomization
Other Total mortality Total mortality 3 months and 1 year after randomization
Other Incidence symptomatic intracranial hemorrhagic events Incidence symptomatic intracranial hemorrhagic events 3 months and 1 year after randomization
Other Adverse events Adverse events 3 months and 1 year after randomization
Primary 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. 3 months after randomization
Secondary 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. 30 days and 1 year after randomization
Secondary 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) 3 months and 1 year after randomization
Secondary 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. 3 months and 1 year after randomization
Secondary 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). 3 months and 1 year after randomization
Secondary 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). 3 months and 1 year after randomization
Secondary 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). 3 months after randomization
Secondary 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. 3 months and 1 year after randomization
Secondary 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. 3 months and 1 year after randomization
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