Thrombolysis in Early Acute Ischemic Stroke Trial-Blood Pressure Management

NCT07279259 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai East Hospital

Phase

Phase 2

Started

2026-01-15

Last updated

2026-01-21

Condition(s) studied

StrokeAcute Ischemic StrokeThrombolysis

Investigational drug(s) / intervention(s)

Adjusted BP management groupUsual BP management group

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 intravenous thrombolysis, efforts should be made to control the extent of blood pressure reduction. When the blood pressure drops below 180/100 mmHg, antihypertensive treatment should be terminated. Twenty-four hours later, the routine blood pressure management protocol should be reinstated.

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.

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

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

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.

Primary outcome measure(s)

The proportion of symptomatic intracranial hemorrhage — Day 1
The proportion of symptomatic intracranial hemorrhage within 24 hours after thrombolysis according to ECASS III criteria

Trial sites (1)

Facility	City	Region	Status
Shanghai East Hospital	Shanghai	China	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07279259 on ClinicalTrials.gov ↗ ← All trials in China