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

Tongji University

Status and phase

Enrolling

Phase 2

Conditions

Stroke

Thrombolysis

Acute Ischemic Stroke

Treatments

Procedure: Usual BP management group

Procedure: Adjusted BP management group

Study type

Interventional

Funder types

Other

Identifiers

NCT07279259

EAST-BP

Details and patient eligibility

About

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).

Full 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) .

Enrollment

340 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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).

Exclusion criteria

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
Any other physical conditions where the doctor deems participation in this study may be detrimental to the patient
Currently participating in other drug or device clinical trials
mRS score > 2 before onset of the disease.