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

Sponsor
Beijing Tiantan Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04078737
Collaborator
Ministry of Science and Technology of the People´s Republic of China (Other)
6,412
214
2
21.3
30
1.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ticagrelor and Aspirin
  • Drug: Clopidogrel and Aspirin
Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
6412 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Clopidogrel With Aspirin in High-risk Patients With Acute Non-disabling Cerebrovascular Events II
Actual Study Start Date :
Sep 23, 2019
Actual Primary Completion Date :
Jun 24, 2021
Actual Study Completion Date :
Jul 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ticagrelor plus Aspirin Group

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

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

Active Comparator: Clopidogrel plus Aspirin Group

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

Drug: 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

Outcome Measures

Primary Outcome Measures

  1. Any new stroke events (ischemic stroke or hemorrhagic stroke) within 3 months [3 months after randomization]

    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

  1. Any new stroke events within 30 days and 1 year [30 days and 1 year after randomization]

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

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

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

  3. New ischemic stroke within 3 months and 1 year [3 months and 1 year after randomization]

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

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

    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).

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

    (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).

  6. Neurological impairment at 3 months (NIHSS increased≥4 from baseline) [3 months after randomization]

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

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

    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.

  8. Stratified analysis [3 months and 1 year after randomization]

    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.

Other Outcome Measures

  1. Moderate and severe bleeding events according to the GUSTO criteria [3 months after randomization]

    Severe bleeding incidence (GUSTO definition), including fatal bleeding and symptomatic intracranial hemorrhage.

  2. Moderate and severe bleeding events according to the GUSTO criteria [1 year after randomization]

    Severe bleeding incidence (GUSTO definition), including fatal bleeding and symptomatic intracranial hemorrhage.

  3. All bleeding events [3 months and 1 year after randomization]

    All bleeding events (severe/moderate bleeding and intracranial hemorrhage)

  4. Total mortality [3 months and 1 year after randomization]

    Total mortality

  5. Incidence symptomatic intracranial hemorrhagic events [3 months and 1 year after randomization]

    Incidence symptomatic intracranial hemorrhagic events

  6. Adverse events [3 months and 1 year after randomization]

    Adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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);

  1. Can be treated with study drug within 24 hours of symptoms onset*(*Symptom onset is defined by the "last seen normal" principle);

  2. CYP2C19 loss-of-function allele carriers;

  3. 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)

  1. Hematocrit (HCT) <30%

  2. Clear indication for anticoagulation (presumed cardiac source of embolus, e.g., atrial fibrillation, prosthetic cardiac valves known or suspected endocarditis)

  3. History of intracranial hemorrhage or amyloid angiopathy

  4. History of aneurysm (including intracranial aneurysm and peripheral aneurysm)

  5. History of asthma or COPD (chronic obstructive pulmonary disease)

  6. High-risk for bradyarrhythmia (first-degree or second-degree AV block caused by sinus node disease, and brady-arrhythmic syncope without pacemaker)

  7. History of hyperuricemia nephropathy

  8. Anticipated requirement for long-term (>7 days) non-steroidal anti-inflammatory drugs (NSAIDs)

  9. Planned or likely revascularization (any angioplasty or vascular surgery) within the next 3 months

  10. Scheduled for surgery or interventional treatment requiring study drug cessation

  11. Severe non-cardiovascular comorbidity with life expectancy < 3 months

  12. Inability to understand and/or follow research procedures due to mental, cognitive, or emotional disorders

  13. Dual antiplatelet treatment (or more than two antiplatelet agents) in 72 hours before randomization

  14. Current treatment (last dose given within 10 days before randomization) with heparin therapy or oral anti coagulation

  15. Intravenous thrombolytic therapy (such as intravenous rtPA) or mechanical thrombectomy within 24 hours prior to randomization

  16. Gastrointestinal bleed within 3 months or major surgery within 30 days

  17. Diagnosis or suspicious diagnosis of acute coronary syndrome

  18. Participation in another clinical study with an experimental product during the last 30 days

  19. Currently receiving an experimental drug or device

  20. Pregnant, currently trying to become pregnant, or of child-bearing potential and not using birth control

Contacts and Locations

Locations

Site City State Country Postal Code
1 Anqing Municipal Hospital Anqing Anhui China 246003
2 The First Affiliated Hospital of Bengbu Medical College Bengbu Anhui China 233004
3 Beijing Chaoyang Hospital, Capital MedicalUniversity(west Hospital) Beijing Beijing China 100043
4 Beijing Tian tan Hospital Beijing Beijing China 100070
5 Beijing Shunyi Airport Hospital Beijing Beijing China 101318
6 The First Hospital of Fangshan District Beijing Beijing China 102488
7 Beijing Coal Group Hospital Beijing Beijing China
8 Peking University Third Hospital Beijing Beijing China
9 Chongqing People's Hospital Chongqing Chongqing China 400010
10 The Second Affiliated Hospital of Chongqing Medical University Chongqing Chongqing China 400010
11 Chongqing Sanbo Chang 'an Hospital Chongqing Chongqing China 400023
12 Daping Hospital of Army Military Medical University Chongqing Chongqing China 400042
13 The First Affiliated Hospital of Chongqing Medical University Chongqing Chongqing China 400060
14 Chongqing Fifth People's Hospital Chongqing Chongqing China 400062
15 The Third Affiliated Hospital of Chongqing Medical University Chongqing Chongqing China 401120
16 People's Hospital of Rongchang District, Chongqing, Chongqing Chongqing China 402460
17 Chongqing Three Gorges Central Hospital Chongqing Chongqing China 404000
18 Chongqing Kaizhou District People's Hospital Chongqing Chongqing China 405400
19 Chongqing Fuling Central Hospital Chongqing Chongqing China 408000
20 Chongqing Nanchuan District People's Hospital Chongqing Chongqing China 408400
21 Xiushan Tujia and Miao Autonomous County People's Hospital Chongqing Chongqing China 409900
22 The Third Affiliated Hospital of Fujian University of Traditional Chinese Medicine Fuzhou Fujian China 350025
23 Fuzhou Second Hospital Fuzhou Fujian China
24 Sanming First Hospital Affiliated to Fujian Medical University Sanming Fujian China 100043
25 Wuwei People's Hospital Wuwei Gansu China 733000
26 Zhangye People's Hospital Affiliated to Hexi College Zhangye Gansu China 734000
27 Dongguan People's Hospital Dongguan Guangdong China 523000
28 The Second Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong China 510260
29 Nanfang Hospital Of Southern Medical University Guangzhou Guangdong China 510515
30 The First Affiliated Hospital of Jinan University Guangzhou Guangdong China 510632
31 The first Affiliated Hospital of Shantou University Medical College Shantou Guangdong China 515041
32 Guiyang Second People's Hospital Guiyang Guizhou China 550000
33 Affiliated Hospital of Guizhou Medical University Guiyang Guizhou China 550004
34 Hainan West Central Hospital Danzhou Hainan China 571799
35 The First Affiliated Hospital of Hainan Medical University Haikou Hainan China 570102
36 Affiliated Hospital of Hebei Medical University Baoding Hebei China 071000
37 Affiliated Hospital of Hebei University Baoding Hebei China 071000
38 The Affiliated Hospital of Chengde Medical College Chengde Hebei China 067000
39 Hejian People's Hospital Hejian Hebei China 062450
40 HaLixun InternationalPeace Hospital Hengshui Hebei China 053000
41 Hengshui fourth People Hospital(Department of Neurology ward 2) Hengshui Hebei China 053000
42 The Fourth People's Hospital of Hengshui City(Department of Neurology ward 1) Hengshui Hebei China 053000
43 The Second Hospitalof Hebei Medical University Shijiazhuang Hebei China 050000
44 The First Affiliated Hospital of Hebei North University Zhangjiakou Hebei China 75000
45 Second Central Hospital of Baoding Zhuozhou Hebei China 072750
46 Daqing Oilfield Gengeal Hospital Daqing Heilongjiang China 163001
47 Daqing People's Hospital Daqing Heilongjiang China 163361
48 The First Hospital of Harbin Medical University Harbin Heilongjiang China 150001
49 The Second Hospital of Harbin Medical University(Department of Neurology ward 1) Harbin Heilongjiang China 150086
50 The Second Hospital of Harbin Medical University(Department of Neurology ward ) Harbin Heilongjiang China 150086
51 The First Affiliated Hospital of Jiamusi University Jiamusi Heilongjiang China 154002
52 Hongqi Hospital affiliated to Mudanjiang Medical University Mudanjiang Heilongjiang China 157000
53 Qiqihar Rongjian Institute of Stroke Prevention and Treatment Qiqihar Heilongjiang China
54 Anyang People's Hospital Anyang Henan China 455000
55 Changge People's Hospital Changge Henan China 461500
56 Xiuwu County People's Hospital Jiaozuo Henan China 454350
57 Jiyuan People's Hospital Jiyuan Henan China 459000
58 Kaifeng Central Hospital Kaifeng Henan China 475000
59 weishi county Central Hospital Kaifeng Henan China 475500
60 Luohe Central Hospital Luohe Henan China 462000
61 Luoyang Central Hospital Luoyang Henan China 471000
62 The first Affiliated Hospital of Henan University of Science and Technology Luoyang Henan China 471000
63 The Second Affiliated Hospital of Henan University of Science and Technology Luoyang Henan China 471000
64 Luoyang New District People's Hospital Luoyang Henan China 471023
65 Pingdingshan First People's Hospital Pingdingshan Henan China 467000
66 Sanmenxia Central Hospital Sanmenxia Henan China 472000
67 Shangqiu Fourth People's Hospital Shangqiu Henan China 476000
68 Suixian county Hospital of Traditional Chinese Medicine Shangqiu Henan China 476900
69 Xingyang People's Hospital Xingyang Henan China 450100
70 The first Affiliated Hospital of Xinxiang Medical University Xinxiang Henan China 453100
71 The First Affiliated Hospital of Henan University of Traditional Chinese Medicine Zhengzhou Henan China 450000
72 Gongyi People's Hospital Zhengzhou Henan China 451200
73 Zhoukou Yongshan Hospital Zhoukou Henan China 461300
74 Zhumadian Hospital of Traditional Chinese Medicine Zhumadian Henan China 463000
75 Wuhan No.1 Hospital Wuhan Hubei China 430000
76 The Central Hospital of Wuhan Wuhan Hubei China 430014
77 First hospital of Changsha city Changsha Hunan China 410005
78 Chenzhou First People's Hospital Chenzhou Hunan China 423000
79 Fourth People's Hospital of Chenzhou Chenzhou Hunan China 423000
80 The First Affiliated Hospital of Nanhua University Hengyang Hunan China 421001
81 Loudi City Central Hospital Loudi Hunan China 417000
82 shaoyang Central Hospital Shaoyang Hunan China
83 Xiangtan Central Hospital Xiangtan Hunan China 411100
84 Yueyang Second People's Hospital Yueyang Hunan China 414000
85 The first Affiliated Hospital of Baotou Medical College Baotou Inner Mongolia Autonomous Region China 014010
86 Baotou CentralHospital Baotou Inner Mongolia Autonomous Region China 014040
87 The second Affiliated Hospital of Baotou Medical College Baotou Inner Mongolia Autonomous Region China 14030
88 Wuyuan County People's Hospital Bayan Nur Inner Mongolia Autonomous Region China 15100
89 Hulun Buir People's Hospital Buri Inner Mongolia Autonomous Region China 21000
90 Chifeng City Hospital Chifeng Inner Mongolia Autonomous Region China 024000
91 Affiliated Hospital of Chifeng University Chifeng Inner Mongolia Autonomous Region China 024005
92 Inner Mongolia People's Hospital Hohhot Inner Mongolia Autonomous Region China 010017
93 Inner Mongolia International Mongolian Hospital Hohhot Inner Mongolia Autonomous Region China 010069
94 Shangrao City People's Hospital Shangrao Jiang XI China
95 Huaian Hospital of Traditional Chinese Medicine Huai'an Jiangsu China 223001
96 Lianshui County People's Hospital Huai'an Jiangsu China 223400
97 The Second People's Hospital of Lianyungang Lianyungang Jiangsu China 222023
98 Nanjing Jiangning Hospital Nanjing Jiangsu China 210000
99 The Second Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu China 210003
100 Nanjing Gulou Hospital Nanjing Jiangsu China 210008
101 BenQ Hospital affiliated to Nanjing Medical University Nanjing Jiangsu China 210019
102 Jiangsu Provincial Hospital of Traditional Chinese Medicine Nanjing Jiangsu China 210029
103 Nanjing Brain Hospital Nanjing Jiangsu China 210029
104 The Fourth Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu China 210031
105 Nanjing Jiangbei People's Hospital Nanjing Jiangsu China 210048
106 Nanjing Gaochun People's Hospital Nanjing Jiangsu China 211300
107 Nantong 6th People's Hospital Nantong Jiangsu China 226000
108 Nantong Hospital of Traditional Chinese Medicine Nantong Jiangsu China 226000
109 The Third People's Hospital in Tongzhou District, Nantong Nantong Jiangsu China 226000
110 Affiliated Hospital of Nantong University Nantong Jiangsu China 226001
111 Nantong First People's Hospital Nantong Jiangsu China 226001
112 Nantong Second People's Hospital Nantong Jiangsu China 226002
113 Nantong Fourth People's Hospital Nantong Jiangsu China 226005
114 Nantong Third People's Hospital Nantong Jiangsu China 22600
115 Tongzhou District People's Hospital of Nantong City Nantong Jiangsu China 226300
116 Rudong County People's Hospital Nantong Jiangsu China 226400
117 Rugao People's Hospital Nantong Jiangsu China 226500
118 Hai 'an People's Hospital Nantong Jiangsu China 226600
119 Tongzhou District 8th People's Hospital of Nantong City Nantong Jiangsu China
120 Siyang County People's Hospital Suqian Jiangsu China 223700
121 Siyang Kangda Hospital Suqian Jiangsu China 223700
122 Suqian People's Hospital Suqian Jiangsu China 223800
123 Suzhou Municipal Hospital Suzhou Jiangsu China 215000
124 The Second Affiliated Hospital of Soochow University Suzhou Jiangsu China 215004
125 Taizhou People's Hospital Taizhou Jiangsu China 225300
126 Xinghua People's Hospital Taizhou Jiangsu China 225700
127 Wuxi People's Hospital Wuxi Jiangsu China 214000
128 Affiliated Hospital of Jiangnan University Wuxi Jiangsu China 214041
129 Yixing People's Hospital Wuxi Jiangsu China 214200
130 Jiangyin People's Hospital Wuxi Jiangsu China 214400
131 xuzhou Central Hospital Xuzhou Jiangsu China 221000
132 Xuzhou coal mining group General Hospital Xuzhou Jiangsu China 221000
133 Affiliated Hospital of Xuzhou Medical University(Department of Neurology ward 1) Xuzhou Jiangsu China 221002
134 Affiliated Hospital of Xuzhou Medical University(Department of Neurology ward 2) Xuzhou Jiangsu China 221002
135 Subei People's Hospital of Jiangsu province Yangzhou Jiangsu China 225009
136 Affiliated Hospital of Yangzhou University Yangzhou Jiangsu China 225012
137 The fourth peoples hospital of zhenjiang city Zhenjiang Jiangsu China 212001
138 Ganzhou city people's Hospital Ganzhou Jiangxi China 341000
139 The First People's Hospital of Jingdehzne City Jingdezhen Jiangxi China 333000
140 Affiliated Hospital of Jiujiang College Jiujiang Jiangxi China 332000
141 Jiujiang first people's Hospital Jiujiang Jiangxi China 332000
142 First Affiliated Hospital of Nanchang University Nanchang Jiangxi China 330000
143 Jiangxi Provincial People's Hospital Nanchang Jiangxi China 330006
144 Sino-Japanese Friendship Hospital Of Jilin University Changchun Jilin China 130031
145 The First Hospital Of Jilin University Changchun Jilin China 130031
146 Jilin Provincial People's Hospital Changchun Jilin China
147 Xinhua Hospital affiliated to Dalian University Dalian Liaoning China 116023
148 Second People's Hospital of Huludao City Huludao Liaoning China
149 Shengjing Hospital of China Medical University Shenyang Liaoning China 110004
150 First People's Hospital of Shenyang Shenyang Liaoning China 110041
151 Guyuan people's hospital Guyuan Ningxia Hui Autonomous Region China 756000
152 The Fifth People's Hospital of Ningxia Hui Autonomous Region Shizuishan Ningxia Hui Autonomous Region China 753000
153 The Second People's Hospital of Shizuishan Shizuishan Ningxia Hui Autonomous Region China 753000
154 Shizuishan First People's Hospital Shizuishan Ningxia Hui Autonomous Region China 753200
155 Second people's Hospital of shizuishan Shizuishan Ningxia Hui Autonomous Region China 753400
156 General Hospital of Ningxia Medical University Yinchuan Ningxia Hui Autonomous Region China 750001
157 Yinchuan First People's Hospital Yinchuan Ningxia Hui Autonomous Region China 750001
158 Cardiovascular and Cerebrovoscular Hospital of General Hospital of Ningxia Med. Univ Yinchuan Ningxia Hui Autonomous Region China 750002
159 People's Hospital of Ningxia Hui Autonomous Region Yinchuan Ningxia Hui Autonomous Region China 750002
160 Zhongwei People's Hospital Zhongwei Ningxia Hui Autonomous Region China 755000
161 Baoji High-tech People's Hospital Baoji Shaanxi China 721000
162 weinan Central Hospital Weinan Shaanxi China 714000
163 Xi 'an Hi-tech Hospital Xi'an Shaanxi China 710000
164 Xi 'an Fengcheng Hospital Xi'an Shaanxi China 710016
165 Xian 141 Hospital Xi'an Shaanxi China 710089
166 Dezhou People's Hospital Dezhou Shandong China 2530000
167 Ningjin County People's Hospital Dezhou Shandong China 253400
168 Shandong Provincial Hospital Jinan Shandong China 250021
169 Liaocheng City Third People's Hospital Liaocheng Shandong China 252000
170 Liaocheng People's Hospital Liaocheng Shandong China 252000
171 Liaocheng Veterans Hospital Liaocheng Shandong China 252000
172 The Brain Hospital of Liaocheng People's Hospital Liaocheng Shandong China 252000
173 Guanxian People's Hospital LiaoCheng Shandong China 252500
174 Liaocheng City Second People's Hospital Liaocheng Shandong China 252601
175 Dongchangfu people's Hospital Liaocheng Shandong China
176 Liaocheng Central Hospital Liaocheng Shandong China
177 Linqing People's Hospital Linqing Shandong China 252600
178 Qingdao Municipal Hospital Qingdao Shandong China 266000
179 Affiliated Hospital of Qingdao University Medical College Qingdao Shandong China 266071
180 Qingdao West Coast New Area People's Hospital Qingdao Shandong China 266400
181 Affiliated Hospital of Weifang Medical University Weifang Shandong China
182 Sunshine Union Hospital Weifang Shandong China
183 weihai Central Hospital Weihai Shandong China 264400
184 Wendeng District People's Hospital Weihai Shandong China 264400
185 Penglai People's Hospital Yantai Shandong China 265600
186 Yantai Beihai Hospita Yantai Shandong China 265701
187 Putuo District Central Hospital Shanghai Shanghai China 200062
188 Shanghai 7th People's Hospital Shanghai Shanghai China 200137
189 Changzhi People's Hospital Changzhi Shanxi China 046000
190 Heping Hospital affiliated to Changzhi Medical College Changzhi Shanxi China 046000
191 Datong Fifth People's Hospital Datong Shanxi China 037000
192 The Third People's Hospital of Datong Datong Shanxi China 037008
193 Shanxi cardiovascular disease hospital Taiyuan Shanxi China 030024
194 Shanxi Bethune Hospital Taiyuan Shanxi China 30000
195 Taiyuan Iron and Steel (Group) Co, Ltd,General Hospital Taiyuan Shanxi China 30001
196 The First Hospital of Shanxi Medical University Taiyuan Shanxi China
197 Xi 'an First Hospital Xi'an Shanxi China
198 Shenzhen Integrated Chinese and Western Medicine Hospital Shenzhen Shenzhen China 100191
199 Shenzhen Luohu People's Hospital Shenzhen Shenzhen China 518001
200 Shenzhen Second People's Hospital Shenzhen Shenzhen China 518035
201 Huazhong University of Science and Technology Union Shenzhen Hospital Shenzhen Shenzhen China 518052
202 West China Hospital Of Sichuan University Chengdou Sichuan China 610041
203 Chengdu second Municipal People'sHospital Chengdu Sichuan China 610000
204 Sichuan Provincial People's Hospital Chengdu Sichuan China 610072
205 dazhou Central Hospital Dazhou Sichuan China 635099
206 Tianjin Medical University General Hospital Tianjin Tianjin China 300052
207 First Affiliated Hospital of Xinjiang Medical University Guiyang Xinjiang Autonomous Region China 8300054
208 People's Hospital Of Xinjiang Uygur Autonomous Region Urumqi Xinjiang Autonomous Region China 830001
209 Friendship Hospital of Ili Kazak Autonomous Prefecture Yining Xinjiang Autonomous Region China 835000
210 First People's Hospital of Yunnan Province Kunming Yunnan China 650000
211 Hangzhou first people's Hospital Hangzhou Zhejiang China 310006
212 lishui municipal Central Hospital Lishui Zhejiang China 323000
213 Zhejiang Wenzhou Medical College Third Affiliated Hospital Ruian Zhejiang China 325200
214 Taizhou First People's Hospital Taizhou Zhejiang China 318020

Sponsors and Collaborators

  • Beijing Tiantan Hospital
  • Ministry of Science and Technology of the People´s Republic of China

Investigators

  • Principal Investigator: Yongjun Wang, M.D, Beijing Tian Tan Hospital, Capital Medical University, Beijing, China

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yongjun Wang, President of Beijing Tiantan Hospital, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier:
NCT04078737
Other Study ID Numbers:
  • 2017ZX09304018001
  • NCT04952311
First Posted:
Sep 6, 2019
Last Update Posted:
Dec 2, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yongjun Wang, President of Beijing Tiantan Hospital, Beijing Tiantan Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 2, 2021