Thrombolysis in Early Acute Ischemic Stroke Trial-Blood Pressure Management (EAST-BP)

Thrombolysis in Early Acute Ischemic Stroke Trial-Blood Pressure Management, EAST-BP

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).

Study Overview

• Status: Recruiting
• Conditions: Stroke; Acute Ischemic Stroke; Thrombolysis
• Intervention / Treatment: Procedure: Usual BP management group; Procedure: Adjusted BP management group

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 Type: Interventional
• Enrollment (Estimated): 340
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Gang Li; Phone Number: +86 021-38804518; Email: ligang@tongji.edu.cn

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Shanghai East Hospital
    • Contact: Gang Li; Phone Number: +86 021-38804518; Email: ligang@tongji.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18 to 80 years (inclusive);
2. Patients with acute ischemic stroke;
3. Planned to receive intravenous thrombolysis within 4.5 hours of onset;
4. Elevated blood pressure: Before receiving intravenous thrombolysis treatment, blood pressure is elevated: systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg (defined as two consecutive measurements within 2 minutes);
5. Informed consent signed (or signed by a proxy).

Exclusion Criteria:

1. Intracranial hemorrhage is indicated on CT or MRI (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural or epidural hematoma).
2. History of intracranial hemorrhage; severe head trauma or stroke within the last 3 months.
3. Intracranial tumors, giant intracranial aneurysms.
4. Intracranial or spinal surgery within the last 3 months; major surgery within the last 2 weeks; arterial puncture at a site not easily compressed for hemostasis within the last 7 days.
5. Gastrointestinal or urinary system bleeding within the last 3 weeks.
6. Aortic dissection.
7. Acute bleeding tendency, including platelet count < 100×10^9/L or other bleeding tendencies.
8. Received low-molecular-weight heparin orally within 24 hours; taking warfarin with INR > 1.7 or PT > 15 seconds; used a new oral anticoagulant within 48 hours.
9. Blood glucose < 2.8 mmol/L or > 22.2 mmol/L.
10. Large area cerebral infarction indicated on head CT or MRI (infarction area > 1/3 of the middle cerebral artery territory).
11. Active visceral hemorrhage, known bleeding diathesis or significant bleeding disorders within the past 6 months
12. Severe ischemic stroke (NIHSS score > 25)
13. Epileptic seizures at the time of stroke onset
14. Pregnant or lactating women
15. Various terminal diseases with an expected survival of ≤ 3 months
16. Any other physical conditions where the doctor deems participation in this study may be detrimental to the patient
17. Currently participating in other drug or device clinical trials
18. mRS score > 2 before onset of the disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Usual BP management group	Procedure: Usual BP management group; 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.
Experimental: Adjusted 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Shanghai East Hospital
• Collaborators: Shanghai 7th People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): August 5, 2028

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 30, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 18, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: thrombolysis; blood pressure; acute ischemic stroke
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Ischemic Stroke; Stroke
• Other Study ID Numbers: EAST-BP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared with bona fide researchers after 1 year following conclusion of the study.
• IPD Sharing Time Frame: 1 year after conclusion of the study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No