Clinical trial NCT03090113: Shuxuetong for Prevention of Recurrence in Acute Cerebrovascular Events With Embolism
Official title: A Random, Double-blind, Parallel, Placebo-controlled, Multi-center Study of Shuxuetong for Prevention of Recurrence in Acute Cerebrovascular Events With Embolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Embolic Stroke
Keywords: Stroke
Embolic Stroke
Shuxuetong
Recurrence
Symptomatic New Cerebral Infarction
Asymptomatic New Cerebral Infarction
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2017-03-24
Enrollment: 2416
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized, double blind, placebo-controlled, parallel, multicenter research in order to evaluate the effect of Shuxuetong injection in prevention of symptomatic or asymptomatic new cerebral infarction within 10 days.

Subgroup study：Evaluate the role of advanced diagnostic technique in identifying potential causes of Embolic Stroke of Undetermined Source (ESUS).

Detailed description: Shuxuetong injection or Placebo injection for 10days. About 2416 patients randomized at 80 centers all over China with 20 subgroup study centers.

Face to face interview at baseline, 10 days, and 90 days.

Eligibility criteria: Inclusion criteria

1. More than or equal to 18 years old and less than 80 years old;
2. Acute ischemic stroke, brain magnetic resonance imaging showed non lacunar infarction (subcortical infarction less than or equal to 1.5 cm);
3. Onset within 72 hours;
4. Patients or their family members are willing to sign the informed consent.

Exclusion criteria

1. Intracranial hemorrhage: cerebral hemorrhage, subarachnoid hemorrhage, etc.;
2. Transient ischemic attack;
3. Lacunar infarction;
4. History of acute stroke within 6 months;
5. Clear diagnosis of other causes of ischemic stroke (arterial dissection, arteritis, vasospasm, etc.);
6. The acute infarcts lesion more than one-half lobe in size;
7. Preceding modified Rankin Scale (mRS) score ≥ 2;
8. Cumulative usage of traditional Chinese medicine which activating blood circulation more than 3 times after onset, including but not limited to: Danhong, Xueshuantong, Xuesaitong, Ginkgo biloba, sodium ozagrel, Salvia miltiorrhiza, ligustrazine, Erigeron breviscapus, etc;
9. Chronic liver disease, liver and kidney dysfunction, lifted alanine aminotransferase (\>3 times the ULN), lifted serum creatinine (\>2 times the ULN）;
10. History of coagulopathy, systemic bleeding, thrombocytopenia or neutropenia;
11. Blood pressure \>90/60 mmHg or ≤220/120 mmHg after treatment;
12. Serious heart or lung disease, in the judgment of clinical study staff, would not suitable to participant in the trial;
13. Patients with atrial fibrillation who were scheduled or likely to receive anticoagulant therapy with unfractionated heparin or low molecular weight heparin within 2 weeks after randomization
14. A medical condition likely to limit survival to less than three months or any other condition judged by the clinic team to likely limit the adherence to study procedures;
15. Known allergies for ingredients of the drug, allergy history for food or drug;
16. Pregnant, currently trying to become pregnant, or of child-bearing potential and not using birth control;
17. Participation in another clinical trial within 30 days;
18. Unable to understand and/or comply with the study procedures and/or follow-up studies due to mental illness, cognitive or emotional disorders.

Subgroup Exclusion Criteria

1. History of atrial fibrillation
2. Atrial fibrillation in 12-lead electrocardiogram (ECG);
3. Heart rate monitoring (dynamic electrocardiogram telemetry) up to 20 hours or more detected atrial fibrillation for 6 minutes or more;
4. Intracardiac thrombosis in thoracic or esophageal echocardiography;
5. Occlusion or proximal vessel infarction for more than 50%.

Primary outcomes:
measure: Symptomatic or Asymptomatic New Cerebral Infarction
timeFrame: 10 days
Secondary outcomes:
measure: Symptomatic Cerebral Infarction
timeFrame: 10 days
measure: Asymptomatic Cerebral Infarction
timeFrame: 10 days
measure: Cerebral Infarction Volume Expansion
timeFrame: 10 days
measure: NIHSS Score Increase
timeFrame: 10 days
measure: Recurrent Symptomatic Stroke(Cerebral infarction, cerebral hemorrhage)
timeFrame: 90 days
measure: Recurrent Symptomatic Ischemic Stroke
timeFrame: 90 days
measure: Combined Vascular Events
timeFrame: 90 days
measure: Disability or Death
timeFrame: 90 days
Other outcomes:
measure: Detected an Atrial Fibrillation Persistent ≥ 30s
timeFrame: 90 days
Locations:
city: Wuhu
country: China
facility: Wuhu No.1 People's Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing Tian Tan Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Ansteel Group Hospital
state: Beijing
city: Beijing
country: China
facility: Beiujing Fengtai Youanmen Hospital
state: Beijing
city: Beijing
country: China
facility: The First Hospital of Fangshan District
state: Beijing
city: Chongqing
country: China
facility: Yongchuan hospital of Traditional Chinese Medicine
state: Chongqing
city: Dongguan
country: China
facility: Houjie Hospital
state: Guangzhou
city: Cangzhou
country: China
facility: Cangzhou Peoole's Hospital
state: Hebei
city: Cangzhou
country: China
facility: People's Hospital of Hejian
state: Hebei
city: Chengde
country: China
facility: Kuancheng County Hospital
state: Hebei
city: Handan
country: China
facility: Traditional Chinese Medicine Hospital of Qiu County
state: Hebei
city: Hengshui
country: China
facility: Hengshui Fourth Hospital
state: Hebei
city: Hengshui
country: China
facility: Jizhou District Hospital of Hengshui
state: Hebei
city: Shijiazhuang
country: China
facility: Shijiazhuang Pingan Hospital Affiliated to Hebei Medical University
state: Hebei
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Jiamusi
country: China
facility: The Second Affiliated Hospital of Jiamusi University
state: Heilongjiang
city: Mudanjiang
country: China
facility: Heilongjiang Province Agricultural Reclamation Mudanjiang Authority Central Hospital
state: Heilongjiang
city: Handan
country: China
facility: Handan Municipal Center Hospital
state: Henan
city: Hengyang
country: China
facility: The First Affiliated Hospital of University of South China
state: Henan
city: Zhengzhou
country: China
facility: People's Hospital of Zhongmu
state: Henan
city: Zhengzhou
country: China
facility: Zhengzhou Yihe Hospital Affiliated to Henan University
state: Henan
city: Jingmen
country: China
facility: Jingmen City Hospital of Traditional Chinese Medicine
state: Hubei
city: Wuhan
country: China
facility: Wuhan NO.1 Hospital,Wuhan Hospital Of Traditional Chinese And Western Medicine
state: Hubei
city: Nanjing
country: China
facility: Jiangsu Province Hospital of TCM
state: Jiangsu
city: Nantong
country: China
facility: Nantong 3rd People's Hospital
state: Jiangsu
city: Suzhou
country: China
facility: Zhangjiagang First People's Hospital
state: Jiangsu
city: Suzhou
country: China
facility: Zhangjiagang Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Chinese Medicine
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical College
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University-the Eastern Division
state: Jilin
city: Huludao
country: China
facility: The Second People's Hospital of Huludao
state: Liaoning
city: Jinzhou
country: China
facility: Jinzhou Medical University
state: Liaoning
city: Baotou
country: China
facility: The First Affiliated Hospital of Baotou Medical College
state: Neimenggu
city: Bayan Nur
country: China
facility: Wu Yuan People's Hospital
state: Neimenggu
city: Chifeng
country: China
facility: Affiliated Hospital of Chifeng University
state: Neimenggu
city: Binzhou
country: China
facility: Huimin People's Hospital
state: Shandong
city: Dezhou
country: China
facility: Ningjin County People's Hospital
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Western Hospital
state: Shandong
city: Penglai
country: China
facility: People's Hospital of Penglai
state: Shandong
city: Qingdao
country: China
facility: People's Hospital of Qingdao West Coast New Area
state: Shandong
city: Qingdao
country: China
facility: Qingdao Haci medical group hospital
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Taiyuan
country: China
facility: First Hospital of Shanxi Medical University
state: Shanxi
city: Shenzhen
country: China
facility: The Second People's Hospital of Shenzhen
state: Shenzhen
city: Dongyang
country: China
facility: Dongyang People's Hopital
state: Zhejiang
city: Lishui
country: China
facility: Lishui People's Hospital
state: Zhejiang
city: Taizhou
country: China
facility: No.1 People's Hospital of Taizhou
state: Zhejiang
city: Wenzhou
country: China
facility: Ruian People's Hospital
state: Zhejiang
Study officials:
affiliation: Beijing Tian Tan Hospital, Capital Medical University, Beijing, China
name: Wang yongjun, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gu HQ, Xie XW, Jing J, Meng X, Lv W, Yu JD, Lv XP, Li H, Wang YL, Wang YJ. Shuxuetong for Prevention of recurrence in Acute Cerebrovascular events with Embolism (SPACE) trial: rationale and design. Stroke Vasc Neurol. 2020 Sep;5(3):311-314. doi: 10.1136/svn-2019-000293. Epub 2020 Feb 27.