Actively Recruiting
Thrombolysis in Early Acute Ischemic Stroke Trial-Blood Pressure Management
Led by Shanghai East Hospital · Updated on 2026-01-21
340
Participants Needed
1
Research Sites
133 weeks
Total Duration
On this page
Sponsors
S
Shanghai East Hospital
Lead Sponsor
S
Shanghai 7th People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is 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).
CONDITIONS
Official Title
Thrombolysis in Early Acute Ischemic Stroke Trial-Blood Pressure Management
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years (inclusive)
- Diagnosis of acute ischemic stroke
- Planned intravenous thrombolysis within 4.5 hours of stroke onset
- Elevated blood pressure before thrombolysis: systolic ≥ 180 mmHg or diastolic ≥ 100 mmHg (two consecutive measurements within 2 minutes)
- Signed informed consent (by patient or proxy)
You will not qualify if you...
- Intracranial hemorrhage shown on CT or MRI
- History of intracranial hemorrhage, severe head trauma or stroke within last 3 months
- Presence of intracranial tumors or giant intracranial aneurysms
- Intracranial or spinal surgery within last 3 months; major surgery within last 2 weeks; arterial puncture at a non-compressible site within last 7 days
- Gastrointestinal or urinary bleeding within last 3 weeks
- Aortic dissection
- Acute bleeding tendency including platelet count < 100×10⁹/L or other bleeding disorders
- Recent use of low-molecular-weight heparin orally within 24 hours; warfarin with INR > 1.7 or PT > 15 seconds; or new oral anticoagulant within 48 hours
- Blood glucose less than 2.8 mmol/L or greater than 22.2 mmol/L
- Large cerebral infarction area greater than one-third of the middle cerebral artery territory on CT or MRI
- Active visceral hemorrhage, bleeding disorders within past 6 months
- Severe ischemic stroke with NIHSS score over 25
- Epileptic seizures at stroke onset
- Pregnant or breastfeeding women
- Terminal diseases with expected survival of 3 months or less
- Any other physical condition considered unsafe by the doctor
- Participation in other drug or device clinical trials
- Modified Rankin Scale score over 2 before stroke onset
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai East Hospital
Shanghai, China
Actively Recruiting
Research Team
G
Gang Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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