Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shuxuetong Injection | Experimental | Shuxuetong Injection,12ml,ivgtt,day1; Shuxuetong Injection,6ml,ivgtt,day2 to day10; |
|
| Placebo Injection | Placebo Comparator | Placebo Injection,12ml,ivgtt,day1; Placebo Injection,6ml,ivgtt,day2 to day10; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shuxuetong Injection | Drug | intravenous drip |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic or Asymptomatic New Cerebral Infarction | Those patients who are still alive at 10 days after randomization will be contacted to set up a follow-up clinical visit. Information of recurrent symptomatic cerebral infarction will be collected and MRI examination will be performed to detect asymptomatic new cerebral infarction. | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic Cerebral Infarction | Those patients who are still alive at 10 days after randomization will be contacted to set up a follow-up clinical visit. Information of recurrent symptomatic cerebral infarction will be collected. | 10 days |
| Asymptomatic Cerebral Infarction |
| Measure | Description | Time Frame |
|---|---|---|
| Detected an Atrial Fibrillation Persistent ≥ 30s | Pre-specified Outcomes for Substudy of 'Etiology Study in Patients with ESUS' | 90 days |
Inclusion criteria
Exclusion criteria
Subgroup Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wang yongjun, MD | Beijing Tian Tan Hospital, Capital Medical University, Beijing, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuhu No.1 People's Hospital | Wuhu | Anhui | China | |||
| Beijing Tian Tan Hospital, Capital Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32994371 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo Injection | Drug | intravenous drip |
|
|
Those patients who are still alive at 10 days after randomization will be contacted to set up a follow-up clinical visit. MRI examination including diffusion weighted imaging (DWI) sequence will be performed. |
| 10 days |
| Cerebral Infarction Volume Expansion | Those patients who are still alive at hospital discharge will be contacted to set up a follow-up clinical visit. MRI examination will be performed. | 10 days |
| NIHSS Score Increase | Those patients who are still alive at hospital discharge will be contacted to set up a follow-up clinical visit. Neurological and functional assessments including NIHSS will be performed. | 10 days |
| Recurrent Symptomatic Stroke(Cerebral infarction, cerebral hemorrhage) | Those patients who are still alive at 90days after onset will be contacted by telephone to set up a follow-up clinical visit. Information of recurrent symptomatic stroke will be collected. | 90 days |
| Recurrent Symptomatic Ischemic Stroke | Those patients who are still alive at 90days after onset will be contacted by telephone to set up a follow-up clinical visit. Information of recurrent symptomatic ischmemic stroke will be collected. | 90 days |
| Combined Vascular Events | Combined Vascular Events was defined as a combination of symptomatic stroke, myocardial infarction and vascular death. | 90 days |
| Disability or Death | Disability or Death was defined as a score of 3 to 6 on the modified Rankin Scale at 90days after onset. | 90 days |
| Beijing |
| Beijing Municipality |
| 100050 |
| China |
| Ansteel Group Hospital | Beijing | Beijing Municipality | China |
| Beiujing Fengtai Youanmen Hospital | Beijing | Beijing Municipality | China |
| The First Hospital of Fangshan District | Beijing | Beijing Municipality | China |
| Yongchuan hospital of Traditional Chinese Medicine | Chongqing | Chongqing Municipality | China |
| Houjie Hospital | Dongguan | Guangzhou | China |
| Cangzhou Peoole's Hospital | Cangzhou | Hebei | China |
| People's Hospital of Hejian | Cangzhou | Hebei | China |
| Kuancheng County Hospital | Chengde | Hebei | China |
| Traditional Chinese Medicine Hospital of Qiu County | Handan | Hebei | China |
| Hengshui Fourth Hospital | Hengshui | Hebei | China |
| Jizhou District Hospital of Hengshui | Hengshui | Hebei | China |
| Shijiazhuang Pingan Hospital Affiliated to Hebei Medical University | Shijiazhuang | Hebei | China |
| The Second Hospital of Hebei Medical University | Shijiazhuang | Hebei | China |
| The Second Affiliated Hospital of Jiamusi University | Jiamusi | Heilongjiang | China |
| Heilongjiang Province Agricultural Reclamation Mudanjiang Authority Central Hospital | Mudanjiang | Heilongjiang | China |
| Handan Municipal Center Hospital | Handan | Henan | China |
| The First Affiliated Hospital of University of South China | Hengyang | Henan | China |
| People's Hospital of Zhongmu | Zhengzhou | Henan | China |
| Zhengzhou Yihe Hospital Affiliated to Henan University | Zhengzhou | Henan | China |
| Jingmen City Hospital of Traditional Chinese Medicine | Jingmen | Hubei | China |
| Wuhan NO.1 Hospital,Wuhan Hospital Of Traditional Chinese And Western Medicine | Wuhan | Hubei | China |
| Jiangsu Province Hospital of TCM | Nanjing | Jiangsu | China |
| Nantong 3rd People's Hospital | Nantong | Jiangsu | China |
| Zhangjiagang First People's Hospital | Suzhou | Jiangsu | China |
| Zhangjiagang Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Chinese Medicine | Suzhou | Jiangsu | China |
| The Affiliated Hospital of Xuzhou Medical College | Xuzhou | Jiangsu | China |
| Jiangxi Provincial People's Hospital | Nanchang | Jiangxi | China |
| The First Hospital of Jilin University-the Eastern Division | Changchun | Jilin | China |
| The Second People's Hospital of Huludao | Huludao | Liaoning | China |
| Jinzhou Medical University | Jinzhou | Liaoning | China |
| The First Affiliated Hospital of Baotou Medical College | Baotou | Neimenggu | China |
| Wu Yuan People's Hospital | Bayan Nur | Neimenggu | China |
| Affiliated Hospital of Chifeng University | Chifeng | Neimenggu | China |
| Huimin People's Hospital | Binzhou | Shandong | China |
| People's Hospital of Penglai | Dengzhou | Shandong | China |
| Ningjin County People's Hospital | Dezhou | Shandong | China |
| Shandong Provincial Western Hospital | Jinan | Shandong | China |
| People's Hospital of Qingdao West Coast New Area | Qingdao | Shandong | China |
| Qingdao Haci medical group hospital | Qingdao | Shandong | China |
| The Affiliated Hospital of Qingdao University | Qingdao | Shandong | China |
| First Hospital of Shanxi Medical University | Taiyuan | Shanxi | China |
| The Second People's Hospital of Shenzhen | Shenzhen | Shenzhen | China |
| Dongyang People's Hopital | Dongyang | Zhejiang | China |
| Lishui People's Hospital | Lishui | Zhejiang | China |
| No.1 People's Hospital of Taizhou | Taizhou | Zhejiang | China |
| Ruian People's Hospital | Wenzhou | Zhejiang | China |
| ID | Term |
|---|---|
| D000083262 | Embolic Stroke |
| D020521 | Stroke |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C532053 | shuxuetong |
Not provided
Not provided
Not provided