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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
2,416
intravenous drip
intravenous drip
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.
Time frame: 10 days
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.
Time frame: 10 days
Asymptomatic Cerebral Infarction
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Wuhu No.1 People's Hospital
Wuhu, Anhui, China
Beijing Tian Tan Hospital, Capital Medical University
Beijing, Beijing Municipality, 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
...and 38 more locations
Time frame: 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.
Time frame: 90 days
Combined Vascular Events
Combined Vascular Events was defined as a combination of symptomatic stroke, myocardial infarction and vascular death.
Time frame: 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.
Time frame: 90 days