Thrombolysis in Early Acute Ischemic Stroke Trial-Blood Pressure Management

Official title

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

Overview

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).

Detailed 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) .

Interventions

• Procedure Adjusted BP management group
  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 intra
• Procedure Usual BP management group
  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.

Primary outcome measures

• The proportion of symptomatic intracranial hemorrhage [Time frame: Day 1]

Secondary outcome measures (11)

• The proportion of symptomatic intracranial hemorrhage within 24 hours [Time frame: DAY 1]
• The proportion of intracranial hemorrhage transformation [Time frame: Day 1]
• The proportion of major substantive hemorrhage [Time frame: The proportion of major substantive hemorrhage occurring within 24 hours after thrombolysis (PH2)]
• The proportion of severe or life-threatening major hemorrhage [Time frame: DAY 90]
• time to use of reperfusion treatment [Time frame: DAY 1]
• level of physical function [Time frame: DAY 90]
• death or dependency measured by a shift in mRS [Time frame: DAY 90]
• Death [Time frame: DAY 90]
• Neurological function measured by NIHSS [Time frame: day 7 or at discharge]
• Neurological function measured by mRS [Time frame: DAY 7 or at discharge]
• number of patients with serious adverse events [Time frame: DAY 90]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• Shanghai East Hospital — Shanghai

Identifiers

NCT: NCT07279259 · EAST-BP

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗