Ischemic Stroke, Acute
Conditions
Keywords
Ischemic Stroke, Intravenous Thrombolysis, Neuroprotective Therapy, Shuxuening Injection, Randomized Controlled Trial
Brief summary
Shuxuening injection is a multi-target neuroprotective agent, it is expected to play a neuroprotective role on the basis of intravenous thrombolysis therapy. The primary purpose of this multicenter, randomized, double-blind, placebo-parallel controlled trial is to evaluate the efficacy and safety of Shuxuening injection in the treatment with intravenous thrombolysis in patients with ischemic stroke.
Detailed description
Intravenous thrombolysis with rt-PA within the time window is the most effective drug for acute ischemic stroke, but there are still more than 50% patients with functional disability. Neuroprotective agents can reduce brain cell death after cerebral ischemia by blocking all links of ischemic cascade. Shuxuening injection is a multi-target neuroprotective agent, it is expected to play a neuroprotective role on the basis of intravenous thrombolysis therapy. This study is a multicenter, randomized, double-blind, placebo-parallel controlled trial. A total of 1380 patients from 50 centers in China who could be treated within 6 hours of onset and have received or plan to undergo intravenous thrombolytic therapy will be enrolled and randomly assigned, in a 1:1 ratio, to receive Shuxuening injection (20 ml Shuxuening injection + 250 ml 0.9% sodium chloride injection), or to receive Shuxuening injection placebo (20 ml plus 250 ml 0.9% sodium chloride injection); both groups are treated for 10-14 days. The primary efficacy outcome is mRS Score 0 to 1 at 90 days, and the primary safety outcome is adverse events within 90 days.
Interventions
Receiving 20 ml Shuxuening injection plus 250ml 0.9% sodium chloride injection, intravenous drip once a day, for 10-14 days
OTHERPlacebo
Receiving 20 ml placebo Shuxuening injection plus 250ml 0.9% sodium chloride injection, intravenous drip once a day, for 10-14 days.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 or older; * Diagnosed with acute ischemic stroke; * Within 6 hours of onset; * Having received or plan to undergo intravenous thrombolytic therapy; * NIHISS score of 4 to 25 points at enrollment; * Signed informed consent.
Exclusion criteria
* mRS score greater than 1 point before the onset; * Receiving neuroprotective agents, such as edaravone, edaravone dextrocamphorol, butylphthalein, etc. after the onset; * Bleeding or other pathological brain disorders, such as vascular malformations, tumors, abscesses, or other common non-ischemic brain diseases (such as multiple sclerosis), detected by CT/MRI; * History of clotting disorders, systemic bleeding, thrombocytopenia, or neutropenia; * Severe hepatic or renal insufficiency (severe hepatic insufficiency refers to the ALT or AST levels above 3 times the upper limit of normal; severe renal insufficiency refers to the creatinine levels above 2 times the upper limit of normal); * Allergic to Shuxuening injection or preparations containing ginkgo biloba (ginkgo biloba extract); * Women who are pregnant or breastfeeding, and women of childbearing age who have a negative pregnancy test but refuse to take effective contraceptive measures; * Participation in another clinical trial with an experimental product during the last 30 days; * Other participants deemed unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of mRS score 0 to 1 at 90 days after randomization | At 90 days after randomization | The Modified Rankin Scale (mRS) score ranges from 0 to 6, with higher scores indicating worse functional outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The distribution of mRS scores at 90 days after randomization | At 90 days after randomization | The Modified Rankin Scale (mRS) score ranges from 0 to 6, with higher scores indicating worse functional outcome. |
| NIHSS score improvement ≥4 points from baseline at 14 days after randomization or on discharge | At 14 days after randomization or on discharge | The National Institutes of Health Stroke Scale (NIHSS) score ranges from 0 to 42, with higher scores indicating more severe neurological deficit. |
| EQ-5D score at 90 days after randomization | At 90 days after randomization | The European Quality of Life 5-Dimension 3-Level (EQ-5D-3L) includes five dimensions. The sum score on each of the five dimensions ranges from 5 (all domains have level 1) to 15 (all domains have level 3), with higher scores indicating worse health-related quality of life. |
| The proportion of Barthel index score ≥95 points at 90 days after randomization | At 90 days after randomization | The Barthel index score ranges from 0 to 100, with higher scores indicating greater independence. |
| The proportion of mRS score 0 to 2 at 90 days after randomization | At 90 days after randomization | The Modified Rankin Scale (mRS) score ranges from 0 to 6, with higher scores indicating worse functional outcome. |
| Serious adverse events within 90 days after randomization | Within 90 days after randomization | — |
| Symptomatic intracranial hemorrhage (ECASS-III) within 90 days after randomization | Within 90 days after randomization | — |
| Symptomatic intracranial hemorrhage (SITS-MOST PH2) within 90 days after randomization | Within 90 days after randomization | — |
| All-cause death within 90 days after randomization | Within 90 days after randomization | — |
| Adverse events within 90 days after randomization | Within 90 days after randomization | — |
Countries
China
Contacts
Primary ContactAnxin Wang
Outcome results
None listed