A Phase 2 interventional study of Adjusted BP management group and Usual BP management group in Stroke, Acute Ischemic Stroke and Thrombolysis, sponsored by Shanghai East Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by Shanghai East Hospital · Phase 2, Interventional, and Treatment
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) .
7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's planned enrollment of 340 is above the median of 50 across 5,366 interventional studies indexed under Stroke.
Browse Stroke studies →Shanghai East Hospital is the lead sponsor of 92 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Procedure: Usual BP management group
Procedure: Adjusted BP management group
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.
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 symptomatic intracranial hemorrhage
The proportion of symptomatic intracranial hemorrhage within 24 hours after thrombolysis according to ECASS III criteria
Time frame: Day 1
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)
Time frame: DAY 1
The proportion of intracranial hemorrhage transformation
The proportion of any intracranial hemorrhage transformation within 24 hours after thrombolysis
Time frame: Day 1
The proportion of major substantive hemorrhage
Time frame: 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)
Time frame: DAY 90
time to use of reperfusion treatment
Door-to-needle time for intravenous thrombolysis patients
Time frame: 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.
Time frame: 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.
Time frame: DAY 90
Death
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: DAY 90
Plan to share: Yes — Data will be shared with bona fide researchers after 1 year following conclusion of the study.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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Shanghai East Hospital