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This study seeks to evaluate the efficacy and safety of mildronate injection in treating acute ischemic stroke
a randomized, double-blind, placebo-controlled phase II multicenter trial is conducted to evaluate the efficacy and safety of mildronate injection in patients with acute ischemic stroke. patients will be randomized to receive a 14-day treatment of placebo or mildronate (500mg/5ml/each).Primary end-point is the modified Rankin scale at 3 monthes. Secondary end-point is the NIHSS scores and the Barthel index at 8 days and 15days. The safety end-point is defined as the incidence of adverse events, the change of Samples for routine laboratory tests and vital signs. Analysis is by intention to treat.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mildronate | Experimental | infusion of mildronate |
|
| placebo | Placebo Comparator | infusion of placebo mildronate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| infusion of mildronate | Drug | infusion of mildronate(500mg) once a day and for 14 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| the modified Rankin scale | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| NIHSS scores | 8 days | |
| NIHSS scores | 15 days | |
| the Barthel index |
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Inclusion Criteria:
- have a clinical diagnosis of acute ischemic stroke have CT or MRI brain imaging NIHSS scores:5~22 on the first stage
Exclusion Criteria:
- have other intracranial pathologies are pregnant or nursing have significant drug or alcohol misuse have been in a clinical trial in the past 3 months are unlikely to be available for follow-up have been given thrombolytic therapy or medication forbidden by study protocol have a neurological or psychiatric disease
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gang Zhao, MD | Contact | 02984775361 | zhaogang@fmmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Gang Zhao, MD | the Department of Neurology , Xijing Hospital | Study Director |
| Yi Zhu, MD | the Department of Neurology , Xijing Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Department of Neurology , Xijing Hospital | Recruiting | Xi'an | Shaanxi | 710032 | China |
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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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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| placebo |
| Drug |
infusion of plabcebo once a day and for 14 days |
|
| aspirin | Drug | infusion of aspirin (100mg) once a day for days |
|
| 8 days |
| the Barthel index | 15 days |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |