Thrombolysis in Early Acute Ischemic Stroke Trial-Blood Pressure Management

NCT07279259 | Recruiting Phase 2 DMC

• 1 other identifier: EAST-BP
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

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).

Conditions

Stroke; Acute Ischemic Stroke; Thrombolysis

Keywords

acute ischemic stroke; blood pressure; thrombolysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• The proportion of symptomatic intracranial hemorrhage within 24 hours

  DAY 1

• The proportion of intracranial hemorrhage transformation

  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

  DAY 90

• time to use of reperfusion treatment

  DAY 1

Study Arms (2)

Usual BP management group

OTHER

Procedure: Usual BP management group

Adjusted BP management group

EXPERIMENTAL

Procedure: Adjusted BP management group

Interventions

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.

Adjusted BP management group

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.

Usual BP management group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 80 years (inclusive);
• Patients with acute ischemic stroke;
• Planned to receive intravenous thrombolysis within 4.5 hours of onset;
• 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);
• Informed consent signed (or signed by a proxy).

You may not qualify if:

• Intracranial hemorrhage is indicated on CT or MRI (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural or epidural hematoma).
• History of intracranial hemorrhage; severe head trauma or stroke within the last 3 months.
• Intracranial tumors, giant intracranial aneurysms.
• 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.
• Gastrointestinal or urinary system bleeding within the last 3 weeks.
• Aortic dissection.
• Acute bleeding tendency, including platelet count \< 100×10\^9/L or other bleeding tendencies.
• 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.
• Blood glucose \< 2.8 mmol/L or \> 22.2 mmol/L.
• Large area cerebral infarction indicated on head CT or MRI (infarction area \> 1/3 of the middle cerebral artery territory).
• Active visceral hemorrhage, known bleeding diathesis or significant bleeding disorders within the past 6 months
• Severe ischemic stroke (NIHSS score \> 25)
• Epileptic seizures at the time of stroke onset
• Pregnant or lactating women
• Various terminal diseases with an expected survival of ≤ 3 months

Sponsors & Collaborators

• Shanghai East Hospital: lead
• Shanghai 7th People's Hospital: collaborator

Study Sites (1)

Shanghai East Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Gang Li

CONTACT

+86 021-38804518; ligang@tongji.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor is independent of the treatment team
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: central randomization with stratification

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 12, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): August 5, 2028
• Last Updated: January 21, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 1 year after conclusion of the study

Locations

CN (1)