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This clinical trial aims to investigate the safety and efficacy of intensive blood pressure lowering after successful reperfusion with thrombectomy in patients with acute anterior circulation large artery occlusive stroke. The main questions it aims to answer are:
What is the optimal blood pressure range after revascularization with thrombectomy in patients with cerebral embolism? Can intensive blood pressure lowering improve outcomes in cerebral embolism patients following thrombectomy?
Participants will be randomly assigned to either the intervention group, which receives stricter blood pressure control (systolic blood pressure target <120 mmHg), or the control group, which follows a conventional blood pressure management approach (systolic blood pressure target 140-180 mmHg). Outcomes will be assessed during a 3-month follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive blood pressure target group | Experimental |
| |
| Standard blood pressure target group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive blood pressure management | Other | The objective is to achieve a systolic blood pressure (SBP) <120 mmHg within 1 hour after randomization and maintain this target for 48 hours. Intravenous titration is initiated immediately after randomization, with an SBP of 100 mmHg used as the threshold for discontinuing antihypertensive therapy or initiating vasopressors. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional independence at 3 months | A modified Rankin Scale (mRS) score of 0 to 2 | At 90 days after randomization |
| Symptomatic intracerebral hemorrhage | Defined by the Heidelberg Bleeding Classification criteria | At 24±12 hours after randomization |
| All-cause mortality | At 90 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Excellent outcome | A modified Rankin Scale (mRS) score of 0 to 1 | At 90 days after randomization |
| Serious adverse outcome | A modified Rankin Scale (mRS) score of 5 to 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fourth Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215000 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 3, 2024 | Dec 20, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Conventional blood pressure management | Other | The objective is to maintain an SBP of 140-180 mmHg within 1 hour after randomization and sustain this range for 48 hours. Intravenous antihypertensive agents are administered when SBP exceeds 180 mmHg and discontinued once SBP is ≤150 mmHg. |
|
| At 90 days after randomization |
| Shift in scores on the mRS | At 90 days after randomization |
| Infarct volume at follow-up CT scan (24±12h) | At 24±12 hours after randomization |
| NIHSS score at 24 hours | At 24 hours after randomization |
| Change in National Institute of Health Stroke Scale (NIHSS) at 24 hours | At 24 hours after randomization |
| Excellent recovery of NIHSS score at 24 hours | NIHSS 0-1 or improvement of more than 8 | At 24 hours after randomization |
| Change in National Institute of Health Stroke Scale (NIHSS) at 7 days | At 7 days after randomization |
| Edema volume assessed by CT | At 7 days after randomization |
| Health-related quality of life (EQ-5D-3L index score) | Health-related quality of life assessed using the EuroQol EQ-5D-3L descriptive system, converted to an index score using [country]-specific value set. | At 90 days after randomization |
| Health-related quality of life (EQ-5D VAS) | Self-rated health status assessed using the EuroQol visual analog scale (EQ-VAS), ranging from 0 (worst imaginable health) to 100 (best imaginable health). | At 90 days after randomization |
| Asymptomatic ICH | At 24±12 hours after randomization |
| Large cerebral infarction or intracranial hemorrhage requiring neurosurgical intervention | At 7 days after randomization |
| Extracranial hemorrhage | Examples include gastrointestinal bleeding, urinary tract bleeding, oral or nasal mucosal bleeding, and subcutaneous hematoma. | An 7 days after randomization |
| Non-hemorrhagic serious adverse events | At 7 days after randomization |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |