Acute Cerebral Stroke Within 12 Hours for the First Time
Conditions
Keywords
Acute ischemic stroke, Dl-3-n-butylphthalide, Cerebrolysin
Brief summary
The investigators conducted a randomized, double-blind, trial enrolled 60 patients within 12 hours of acute ischemic stroke (AIS) in China. Patients were randomly assigned to receive a 10-day infusion of dl-3-n-butylphthalide (NBP) or cerebrolysin, or placebo. National Institutes of Health Stroke Scale (NIHSS) and Barthel Index (BI) were used to evaluate the efficacy in the patients with AIS at 11-day and 21-day after therapy. Adverse events were also analyzed among the three groups.
Interventions
Intravenous infusion of 100 ml dl-3-n-butylphthalide and sodium chloride injection for 10 days, twice daily.
DRUGCerebrolysin
Intravenous infusion of 30 ml Cerebrolysin per day in 100 ml normal saline for 10 days.
DRUGPlacebo
100 ml saline intravenous infusion once daily for 10 days.
Sponsors
Shanghai 6th People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Acute ischemic stroke within 12 hours for the first time before entry into the study * National Institutes of Health Stroke Scale (NIHSS) score between 6 and 25
Exclusion criteria
* with lacunar infarction * with cerebral hemorrhagic infarction * with epilepsy or epileptic persons * with history of neurological diseases * with myocardial infarction, * with renal and hepatic abnormalities * with metabolic diseases * with contraindications to antiplatelet treatments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| National Institutes of Health Stroke Scale Score | At 11-day and 21-day after therapy | Scores range from 0 to 42, with higher scores indicating increasing severity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Barthel Index Score | At 11-day and 21-day after therapy | Range from 0, indicating complete dependence on help with activities of daily living, to 100, indicating independence |
Countries
China
Participant flow
Recruitment details
From January 2010 to May 2010, a randomized, double-blind trial was conducted, which involved patients with AIS in the Neurology Ward of Shanghai Jiao Tong University Affiliated Sixth People's Hospital (Shanghai, China).
Participants by arm
| Arm | Count |
|---|---|
| Dl-3-n-butylphthalide Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days. | 20 |
| Cerebrolysin Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days. | 20 |
| Placebo Intravenous infusion of 100 ml saline intravenous q.d. for 10 days. | 20 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 4 | 5 |
| Overall Study | Physician Decision | 1 | 2 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 2 | 2 |
Baseline characteristics
| Characteristic | Dl-3-n-butylphthalide | Cerebrolysin | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 67.1 years STANDARD_DEVIATION 6.3 | 66.5 years STANDARD_DEVIATION 8.1 | 68.4 years STANDARD_DEVIATION 4.2 | 67.3 years STANDARD_DEVIATION 6.2 |
| Barthel Index score | 19.75 units on a scale STANDARD_DEVIATION 6.38 | 22.25 units on a scale STANDARD_DEVIATION 7.16 | 22.00 units on a scale STANDARD_DEVIATION 6.96 | 21.33 units on a scale STANDARD_DEVIATION 6.83 |
| Diastolic blood pressure | 88.7 mmHg STANDARD_DEVIATION 10.7 | 85.1 mmHg STANDARD_DEVIATION 13.6 | 87.2 mmHg STANDARD_DEVIATION 12.5 | 87.0 mmHg STANDARD_DEVIATION 12.3 |
| National Institutes of Health Stroke Scale score | 12.4 units on a scale STANDARD_DEVIATION 4.38 | 10.6 units on a scale STANDARD_DEVIATION 4.74 | 10.2 units on a scale STANDARD_DEVIATION 3.72 | 11.1 units on a scale STANDARD_DEVIATION 4.28 |
| Sex: Female, Male Female | 11 Participants | 11 Participants | 10 Participants | 32 Participants |
| Sex: Female, Male Male | 9 Participants | 9 Participants | 10 Participants | 28 Participants |
| Systolic blood pressure | 148.6 mmHg STANDARD_DEVIATION 14.6 | 150.7 mmHg STANDARD_DEVIATION 13.7 | 152.5 mmHg STANDARD_DEVIATION 12.8 | 150.6 mmHg STANDARD_DEVIATION 13.7 |
| Time until admission | 5.4 hour STANDARD_DEVIATION 3 | 5.0 hour STANDARD_DEVIATION 3.3 | 4.8 hour STANDARD_DEVIATION 3.7 | 5.1 hour STANDARD_DEVIATION 3.3 |
| Time until treatment | 7.7 hour STANDARD_DEVIATION 5.9 | 7.6 hour STANDARD_DEVIATION 3.6 | 5.6 hour STANDARD_DEVIATION 3 | 7.0 hour STANDARD_DEVIATION 4.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 16 / 20 | 12 / 20 | 12 / 20 |
| serious Total, serious adverse events | 8 / 20 | 7 / 20 | 11 / 20 |
Outcome results
Primary
National Institutes of Health Stroke Scale Score
Scores range from 0 to 42, with higher scores indicating increasing severity
Time frame: At 11-day and 21-day after therapy
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dl-3-n-butylphthalide | National Institutes of Health Stroke Scale Score | Day 11 | 8.78 units on a scale | Standard Deviation 2.48 |
| Dl-3-n-butylphthalide | National Institutes of Health Stroke Scale Score | Day 21 | 5.48 units on a scale | Standard Deviation 2.34 |
| Cerebrolysin | National Institutes of Health Stroke Scale Score | Day 11 | 7.80 units on a scale | Standard Deviation 5.81 |
| Cerebrolysin | National Institutes of Health Stroke Scale Score | Day 21 | 5.90 units on a scale | Standard Deviation 3.96 |
| Placebo | National Institutes of Health Stroke Scale Score | Day 21 | 7.30 units on a scale | Standard Deviation 4.78 |
| Placebo | National Institutes of Health Stroke Scale Score | Day 11 | 8.85 units on a scale | Standard Deviation 4.43 |
Secondary
Barthel Index Score
Range from 0, indicating complete dependence on help with activities of daily living, to 100, indicating independence
Time frame: At 11-day and 21-day after therapy
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dl-3-n-butylphthalide | Barthel Index Score | Day 11 | 35.25 units on a scale | Standard Deviation 10.57 |
| Dl-3-n-butylphthalide | Barthel Index Score | Day 21 | 54.00 units on a scale | Standard Deviation 14.01 |
| Cerebrolysin | Barthel Index Score | Day 11 | 36.00 units on a scale | Standard Deviation 10.81 |
| Cerebrolysin | Barthel Index Score | Day 21 | 53.75 units on a scale | Standard Deviation 13.1 |
| Placebo | Barthel Index Score | Day 11 | 31.00 units on a scale | Standard Deviation 8.68 |
| Placebo | Barthel Index Score | Day 21 | 43.75 units on a scale | Standard Deviation 15.5 |