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This study plans to enroll 1248 patients with supratentorial ICH within 24 hours of onset across multiple stroke centers. After randomization, the control group will only receive medical therapy. The experimental group, after randomization, will receive an initial dose of 200 mg of minocycline hydrochloride capsules in addition to medical ttherapy, followed by 100 mg orally every 12 hours for 7 days, resulting in a total of 14 administrations. Both groups will be followed for 180 days to evaluate the efficacy and safety of minocycline in the treatment of ICH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | The experimental group will receive an initial dose of 200 mg of minocycline hydrochloride capsules in addition to medical therapy after randomization, followed by 100 mg orally every 12 hours for 7 days, totaling 14 administrations. |
|
| Control group | No Intervention | The control group will only receive medical therapy after randomization. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minocycline | Drug | The experimental group will receive an initial dose of 200 mg of minocycline hydrochloride capsules in addition to medical therapy after randomization, followed by 100 mg orally every 12 hours for 7 days, totaling 14 administrations. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with favorable functional outcomes, defined as mRS 0-2 at 180 days. | Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome. | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with an mRS score of 0-1 at 180 days. | Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome. | 180 days |
| The proportion of patients with favorable functional outcome (mRS score of 0-2) at 90 days. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of any adverse events during the study period. | Adverse events. | 180 days |
| The incidence of serious adverse events during the study period. | Serious adverse events. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Yang, Pro | Contact | 88782378 | 0431 | doctoryangyi@163.com |
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| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D008911 | Minocycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome. |
| 90 days |
| The proportion of patients with an mRS score of 0-1 at 90 days. | Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome. | 90 days |
| The distribution of mRS scores at 90 days and 180 days. | Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome. | 90 days and 180 days |
| The NIHSS scores after 7 days of treatment. | The NIHSS is an ordinal hierarchical scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit. | 7 days |
| 180 days |
| The incidence of minocycline-related adverse events during the study period. | Minocycline-related adverse events. | 180 days |
| Mortality during the study period. | Mortality. | 180 days |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |