RecruitingPhase 4NCT04624295

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

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


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

294 participants

Start Date

Jan 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Inclusion Criteria3

  • Acute ischemic patients receiving intravenous thrombolysis within 24 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 Criteria5

  • 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;

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Interventions

DRUGEarly aspirin Therapy

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.

DRUGNon-Early aspirin Therapy

Antiplatelet therapy will be delayed to beyond 48 hours after stroke onset and may not be initiated until hemorrhagic Infarction has been confirmed absorbed.


Locations(1)

the second affiliated hospital of Zhejiang University

Hangzhou, China

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