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| Name | Class |
|---|---|
| Capital Medical University | OTHER |
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The main purpose of the study: To evaluate the effect of nitrosone 1 special for patients with acute ischemic cerebral stroke. The secondary purpose of the study: To evaluate the effectiveness of the injection of nitrosone I. T for loyal patients with acute ischemic stroke All women think.
The main purpose of the study: To evaluate the effect of nitrosone 1 special for patients with acute ischemic cerebral stroke. The secondary purpose of the study: To evaluate the effectiveness of the injection of nitrosone I. T for loyal patients with acute ischemic stroke All women think.
This experiment adopts randomized, double-blind, placebo-controlled parallel design. In patients with acute, ischemic cerebral rate as the research object, after selected exclusion standard screening, if doesn't fit or don't agree with thrombolysis subjects, giving from connect to test a drug or a placebo treatment, if appropriate and agreed to thrombolysis of the subjects with an experimental drug or placebo after thrombolysis treatment.Intervention group: 30) min uniform given 1400 mg intravenous drip injection with ketone wordy, nitrate dosing volume 100 ml. Day delivery, two intervals of 12 h, for seven days in a row, namely to 14 times in total.The placebo group: 30 min to 100 ml placebo at a constant speed intravenous drip (sodium chloride injection), dosing W times a day, 12 h, for seven days in a row, namely to 14 times in total.During treatment, participants in the group after injection with nitrate ketone oxazine (giving injections with nitrate ketone oxazine time window < 6 h, that is, from "the last look normal time" to start infusion nitrate obviously time) or placebo and other foundation treatment. Record for the first time to give the time of nitrate ketone oxazine or placebo for injection, lie between 8 and 12 h 2 times to medicine."After 12 h dosing interval, until finish to 14 times (for convenient subjects out of the hospital and acceptable to 13).Allow this study drug and placebo and thrombolysis drug dosing dual channel at the same timeStop to test drug or placebo, in the group of 8 days, 14 days, 30 days, the 90th day to evaluate curative effect, respectively.In the I the ili is not ah into subgroups according to try tii statistical treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Intervention group: 30min intravenous point. Infusion of 1400 mg of tetranitrone was given to bed I with a dose of 100ml, twice a day, with an interval of 12 hours, and continued administration for 7 days, that is, a total of about 14 times. version |
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| Placebo group | Placebo Comparator | Placebo group: 30 minutes to earn pulse, I, 1, and dripping Yunmi gave 100mL placebo (sodium chloride injection). It is administered twice a day for 1 to 2 hours, and the pattern is transferred to about 7 people, that is, about 14 times in total. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitrate ketone oxazine | Drug | Intervention group: 30min intravenous point. Drop qiu was given 1400 mg of injected sichuan nitrone I bed, and the drug was given 100 mL at day F Set 12 h, and at odds with another 7 days, that is, about 14 times in total. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with NIHSS ≤1 or a reduction of 4 or more points from baseline | Percentage of patients with NIHSS ≤1 or a reduction of 4 or more points from baseline at day 14 of treatment | On the 14th day of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The change of MRS score | The change of MRS score (change detection and rate of change) at the 30th day and the 90th day of treatment compared with the plexus line. | 30th day and the 90th day of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yongjun Wang | Tiantan Hospital, Capital Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| : Beijing Dan's self technology co., LTD. | Beijing | China | ||||
| Tiantan Hospital, Capital Medical University |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Beijing |
| China |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |