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

NCT04624295 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 294

Last updated 2025-06-15

No results posted yet for this study

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.

Conditions

  • Antiplatelet Therapy
  • Hemorrhagic Infarction

Interventions

DRUG

Early 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.

DRUG

Non-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.

Sponsors & Collaborators

  • Shaoxing People's Hospital

    collaborator OTHER
  • Affiliated Hospital of Jiaxing University

    collaborator OTHER
  • Huzhou Central Hospital

    collaborator OTHER
  • The Second Affiliated Hospital of Jiaxing University

    collaborator OTHER
  • Jinhua Central Hospital

    collaborator OTHER
  • Taizhou Hospital

    collaborator OTHER
  • Ningbo Medical Center Lihuili Hospital

    collaborator OTHER_GOV
  • Ningbo No.2 Hospital

    collaborator OTHER
  • Lishui Country People's Hospital

    collaborator OTHER
  • Wenzhou Central Hospital

    collaborator OTHER
  • The Fourth Affiliated Hospital of Zhejiang University School of Medicine

    collaborator OTHER
  • Shenzhen Second People's Hospital

    collaborator OTHER
  • The Affiliated Hospital of Xuzhou Medical University

    collaborator OTHER
  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Min Lou, PhD · Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2025-12-31
Completion
2026-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04624295 on ClinicalTrials.gov