Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT07279259
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-12
First Post:
2025-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thrombolysis in Early Acute Ischemic Stroke Trial-Blood Pressure Management
Sponsor:
Shanghai East Hospital
Organization:
Study Overview
Official Title:
Thrombolysis in Early Acute Ischemic Stroke Trial-Blood Pressure Management, EAST-BP
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EAST-BP
Brief Summary:
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).
Detailed Description:
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) .
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: