Blood pressure management during early clot‑busting treatment for acute ischemic stroke

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

This trial will test whether an adjusted blood pressure approach is safer than usual care for people with acute ischemic stroke who are receiving IV thrombolysis and have high blood pressure.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 340 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shanghai East Hospital (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT07279259 on ClinicalTrials.gov

What this trial studies

EAST-BP is a Phase II, multicenter, open-label randomized trial with blinded endpoint assessment comparing an adjusted blood pressure management strategy to conventional management during intravenous thrombolysis for acute ischemic stroke. Adults aged 18–80 who present within 4.5 hours and have elevated blood pressure before treatment (SBP ≥180 mmHg or DBP ≥100 mmHg) are randomized to one of the two BP strategies. The primary safety focus is symptomatic intracranial hemorrhage within 24 hours after thrombolysis, with additional outcomes including major hemorrhage, door-to-needle time, 90-day functional independence (mRS 0–2), 90-day mortality, and early neurological status. Outcomes are followed through 90 days with blinded adjudication of bleeding events and functional endpoints.

Who should consider this trial

Good fit: Adults aged 18–80 with acute ischemic stroke who present within 4.5 hours, are planned for IV thrombolysis, and have elevated blood pressure (SBP ≥180 mmHg or DBP ≥100 mmHg) are the intended participants.

Not a fit: Patients with evidence of intracranial hemorrhage, recent major head trauma or intracranial surgery, certain intracranial lesions, or those outside the thrombolysis window are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could reduce dangerous brain bleeding after thrombolysis and improve chances of independent recovery at 90 days.

How similar studies have performed: Prior trials of perithrombolysis blood pressure lowering have produced mixed results—some showed reduced hemorrhage risk without clear benefit on overall disability—so this approach remains an active but not yet settled area of study.

Eligibility criteria

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.

Where this trial is running

Shanghai

• Shanghai East Hospital — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Gang Li

Conditions Stroke; Acute Ischemic Stroke; Thrombolysis; acute ischemic stroke; blood pressure; thrombolysis