Early Antiplatelet Therapy After Hemorrhagic Infarction in Acute Ischemic Stroke Treated With Intravenous Thrombolysis (HITs)

Study Overview
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Brief Summary
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Previous study showed that the proportions of hemorrhagic Infarction after intravenous thrombolysis were 24.2% and 32.5% in the control group and the alteplase group, and most of them were asymptomatic. Hemorrhagic Infarction was a part of the natural progression after acute ischemic stroke. Previous study have shown no significant relationship between hemorrhagic Infarction and poor outcome in acute ischemic stroke (AIS) patients. In this study, a randomized controlled trial will be conducted to explore the efficacy and safety of early antiplatelet therapy after hemorrhagic infarction in acute ischemic stroke treated with intravenous thrombolysis.

Official Title
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Early Antiplatelet Therapy After Hemorrhagic Infarction in Acute Ischemic Stroke Treated With Intravenous Thrombolysis in China (HITs)：a Randomized Clinical Trial

Conditions
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Antiplatelet Therapy, Hemorrhagic Infarction

Intervention / Treatment
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* Drug: Early aspirin Therapy
* Drug: Non-Early aspirin Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute ischemic patients receiving intravenous thrombolysis within 4.5 hours upon stroke onset Be confirmed as Hemorrhagic Infarction at 24 to 36 hours after intravenous thrombolysis by computerized tomography The patient or family member signed an informed consent Exclusion Criteria: Early use of anticoagulant drugs within 1 week after intravenous thrombolysis; Tirofiban was used after receiving endovascular treatment; Intraoperative stent placement after receiving endovascular treatment; Subarachnoid hemorrhage or ventricular hemorrhage; There are contraindications for aspirin use;
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early Antiplatelet Therapy<br> | Drug: Early aspirin Therapy<br>* Early Antiplatelet Therapy is administered within 24 to 48 hours after stroke onset and the dose is determined by the clinician. Aspirin was chosen for antiplatelet therapy.<br>|
| Placebo Comparator: Non-Early Antiplatelet Therapy<br> | Drug: Non-Early aspirin Therapy<br>* Antiplatelet therapy will be delayed to beyond 48 hours after stroke onset and may not be initiated until hemorrhagic Infarction has been confirmed absorbed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with modified Rankin scale (mRS) ≤2 | The proportion of patients with modified Rankin scale (mRS) ≤2 at 90 days, on which scores range from 0 (no neurologic deficit) to 6 (death)]. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemorrhage volume enlargement after intravenous thrombolysis | Hemorrhage volume enlargement after intravenous thrombolysis at 7 days | 7 days | 
| Hemorrhage volume reduction after intravenous thrombolysis | Hemorrhage volume reduction after intravenous thrombolysis at 7 days | 7 days | 
| the progress of National Institute of Health Stroke Scale (NIHSS) scores | the progress of National Institute of Health Stroke Scale (NIHSS) scores at 7 days, on which scores range from 0 (no neurologic deficit) to 42 (severe)] | 7 days | 
| Enlarged infarct volume within 7 days | Enlarged infarct volume within 7 days | 7 days | 
| the distribution of modified Rankin scale (mRS) | the distribution of modified Rankin scale (mRS) at 90 days, on which scores range from 0 (no neurologic deficit) to 6 (death)] | 90 days | 
| Recurrence rate of acute ischemic stroke | Recurrence rate of acute ischemic stroke at 90 days | 90 days | 
| Recurrence rate of cerebrovascular disease | Recurrence rate of cerebrovascular disease at 90 days | 90 days | 
| Recurrence rate of acute ischemic stroke | Recurrence rate of acute ischemic stroke at 1 years | 1 year | 
| Recurrence rate of cerebrovascular disease | Recurrence rate of cerebrovascular disease at 1 year | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute ischemic stroke, intravenous thrombolysis, Hemorrhagic Infarction, antiplatelet therapy