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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Shanghai East Hospital
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Gang Li
• Email: ligang@tongji.edu.cn
• Phone: +86 021-38804518

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.