A Phase 4 interventional study of Shuxuetong Injection and Placebo Injection in Embolic Stroke, sponsored by Beijing Tiantan Hospital. Completed at 48 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-07-22.
Sponsored by Beijing Tiantan Hospital · Phase 4, Interventional, and Prevention
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.
40 studies on the registry are indexed under Embolic Stroke; 11 are open to participants now.
This study's enrollment of 2,416 is above the median of 197 across 13 interventional studies indexed under Embolic Stroke.
Browse Embolic Stroke studies →Beijing Tiantan Hospital is the lead sponsor of 489 studies on the registry; 293 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria
Subgroup Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Shuxuetong Injection,12ml,ivgtt,day1; Shuxuetong Injection,6ml,ivgtt,day2 to day10;
Drug: Shuxuetong Injection
Placebo Injection,12ml,ivgtt,day1; Placebo Injection,6ml,ivgtt,day2 to day10;
Drug: Placebo Injection
intravenous drip
Also known as: Shuxuetong
intravenous drip
Also known as: Placebo
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.
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
Detected an Atrial Fibrillation Persistent ≥ 30s
Pre-specified Outcomes for Substudy of 'Etiology Study in Patients with ESUS'
Time frame: 90 days
Plan to share: No
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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