Thrombolysis in Early Acute Ischemic Stroke Trial-Blood Pressure Management

Last updated: January 18, 2026
Sponsor: Shanghai East Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Stroke

Cerebral Ischemia

Blood Clots

Treatment

Usual BP management group

Adjusted BP management group

Clinical Study ID

NCT07279259
EAST-BP
  • Ages 18-80
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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, bloodpressure 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

Exclusion Criteria:

  1. Intracranial hemorrhage is indicated on CT or MRI (including parenchymal hemorrhage,intraventricular hemorrhage, subarachnoid hemorrhage, subdural or epiduralhematoma).

  2. History of intracranial hemorrhage; severe head trauma or stroke within the last 3months.

  3. Intracranial tumors, giant intracranial aneurysms.

  4. Intracranial or spinal surgery within the last 3 months; major surgery within thelast 2 weeks; arterial puncture at a site not easily compressed for hemostasiswithin 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 bleedingtendencies.

  8. Received low-molecular-weight heparin orally within 24 hours; taking warfarin withINR > 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 ofthe middle cerebral artery territory).

  11. Active visceral hemorrhage, known bleeding diathesis or significant bleedingdisorders 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 maybe detrimental to the patient

  17. Currently participating in other drug or device clinical trials

  18. mRS score > 2 before onset of the disease.

Study Design

Total Participants: 340
Treatment Group(s): 2
Primary Treatment: Usual BP management group
Phase: 2
Study Start date:
January 15, 2026
Estimated Completion Date:
August 05, 2028

Study 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) .

Connect with a study center

  • Shanghai East Hospital

    Shanghai 1796236,
    China

    Active - Recruiting

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