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| Name | Class |
|---|---|
| Shanghai 7th People's Hospital | OTHER |
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This study is a Phase II, exploratory, prospective, multicenter, open-label, randomized controlled clinical trial with blinded endpoint assessment setting on the safety of an adjusted versus a conventional blood pressure management strategy during intravenous thrombolysis in AIS patients, with a key focus on the incidence of symptomatic intracranial hemorrhage (sICH).
This study is a Phase II, exploratory, prospective, multicenter, open-label, randomized controlled clinical trial with blinded endpoint assessment. EAST-BP aims to investigate the safety of an adjusted versus a conventional blood pressure management strategy during intravenous thrombolysis in AIS patients, according to an ordinal analysis of Proportion of symptomatic intracranial hemorrhage within 24 hours after thrombolysis, proportion of severe or life-threatening major hemorrhage, DNT time for intravenous thrombolysis patients, proportion of independent functional prognosis at 90 days (90-day mRS 0-2), sequential analysis of improved 90-day mRS score for patients, proportion of death at 90 days, and neurological function status at 7 days or at discharge (if hospital stay is less than 7 days) .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual BP management group | Other |
| |
| Adjusted BP management group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjusted BP management group | Procedure | For patients intended to receive intravenous thrombolysis, when the blood pressure ranges from 180/100 mmHg to 200/110 mmHg, simultaneous initiation of both intravenous thrombolysis and antihypertensive treatment can be considered. If the blood pressure exceeds 200/110 mmHg, antihypertensive treatment should be initiated first. Intravenous thrombolysis can be commenced after the blood pressure is reduced to below 200/110 mmHg. Before thrombolysis and within 24 hours after the initiation of intravenous thrombolysis, efforts should be made to control the extent of blood pressure reduction. When the blood pressure drops below 180/100 mmHg, antihypertensive treatment should be terminated. Twenty-four hours later, the routine blood pressure management protocol should be reinstated. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of symptomatic intracranial hemorrhage | The proportion of symptomatic intracranial hemorrhage within 24 hours after thrombolysis according to ECASS III criteria | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of symptomatic intracranial hemorrhage within 24 hours | The proportion of symptomatic intracranial hemorrhage within 24 hours after thrombolysis (ECASS II criteria, SIST-MOST criteria, NINDS criteria) | DAY 1 |
| The proportion of intracranial hemorrhage transformation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gang Li | Contact | +86 021-38804518 | ligang@tongji.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai East Hospital | Recruiting | Shanghai | China |
Data will be shared with bona fide researchers after 1 year following conclusion of the study.
1 year after conclusion of the study
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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central randomization with stratification
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Outcome assessor is independent of the treatment team
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| Usual BP management group | Procedure | To receive blood pressure management according to standard local guidelines. In China, for patients scheduled for intravenous thrombolysis who present with elevated blood pressure, it is advised to maintain blood pressure below 180/100 mmHg for 24 hours, after which standard guideline-based blood pressure management should be resumed. |
|
The proportion of any intracranial hemorrhage transformation within 24 hours after thrombolysis |
| Day 1 |
| The proportion of major substantive hemorrhage | The proportion of major substantive hemorrhage occurring within 24 hours after thrombolysis (PH2) |
| The proportion of severe or life-threatening major hemorrhage | The proportion of severe or life-threatening major bleeding (as defined by GUSTO) | DAY 90 |
| time to use of reperfusion treatment | Door-to-needle time for intravenous thrombolysis patients | DAY 1 |
| level of physical function | Level of function defined across 7 categories of disability on the modified Rankin scale (mRS 0-6) in which scores of 0 or 1 indicate good function without or with symptoms but not disability, socress of 2 indicates slight disability but independence, 3 to 5 indicate increasing levels of disability (and dependency), and a score of 6 indicates death. | DAY 90 |
| death or dependency measured by a shift in mRS | Level of function defined across 7 categories of disability on the modified Rankin scale (mRS 0-6) in which scores of 0 or 1 indicate good function without or with symptoms but not disability, socress of 2 indicates slight disability but independence, 3 to 5 indicate increasing levels of disability (and dependency), and a score of 6 indicates death. | DAY 90 |
| Death | DAY 90 |
| Neurological function measured by NIHSS | NIHSS score at 7 days or at discharge (if the length of hospital stay is less than 7 days) | day 7 or at discharge |
| Neurological function measured by mRS | mRS score at 7 days or at discharge (if the length of hospital stay is less than 7 days) | DAY 7 or at discharge |
| number of patients with serious adverse events | total number of serious adverse events reported during follow-up, according to standard definitions | DAY 90 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |