Actively Recruiting
Early Antiplatelet Therapy After Hemorrhagic Infarction in Acute Ischemic Stroke Treated With Intravenous Thrombolysis in China (HITs): a Randomized Clinical Trial
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-06-15
294
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
Sponsors
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor
S
Shaoxing People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a randomized clinical trial to study acute ischemic stroke patients who have experienced hemorrhagic infarction after intravenous thrombolysis. The trial aims to explore the safety and effectiveness of starting antiplatelet therapy early in these patients. Previous research showed that hemorrhagic infarction often occurs after this treatment but is mostly asymptomatic and not linked to worse outcomes. The study compares two approaches: early antiplatelet therapy with aspirin given within 24 to 48 hours after stroke onset, and delayed antiplatelet therapy started beyond 48 hours or after hemorrhagic infarction has been confirmed absorbed. The aspirin dose will be determined by the clinician. Participants are randomly assigned to one of these two groups in a double-blind design. Participants will be monitored for several outcomes including the proportion with a favorable modified Rankin scale score at 90 days, changes in hemorrhage size at 7 days, stroke severity progress by NIHSS scores, and stroke recurrence rates up to one year. The trial includes clinical assessments, imaging at 24 to 36 hours post-thrombolysis, and follow-up visits to assess recovery and safety. The study is sponsored by the Second Affiliated Hospital, School of Medicine, Zhejiang University.
CONDITIONS
Brief Title
Early Antiplatelet Therapy After Hemorrhagic Infarction in Acute Ischemic Stroke Treated With Intravenous Thrombolysis (HITs)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Acute ischemic stroke patients who received intravenous thrombolysis within 24 hours of stroke onset
- Confirmed hemorrhagic infarction by CT scan 24 to 36 hours after intravenous thrombolysis
- Patient or family member has signed informed consent
You will not qualify if you...
- Use of anticoagulant drugs within 1 week after intravenous thrombolysis
- Use of Tirofiban after endovascular treatment
- Intraoperative stent placement after endovascular treatment
- Presence of subarachnoid hemorrhage or ventricular hemorrhage
- Contraindications to aspirin use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 90 days
Participants receive antiplatelet therapy starting within 24 to 48 hours after stroke onset, with aspirin dose determined by the clinician. Some participants may start therapy later than 48 hours depending on hemorrhagic infarction absorption.
Regular visits during the treatment period
Trial Site Locations
Total: 1 location
1
the second affiliated hospital of Zhejiang University
Hangzhou, China
Actively Recruiting
Research Team
M
Min Lou, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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