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NCT Number: NCT04624295

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

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.

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Key information

Conditions

Antiplatelet Therapy Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhagic Infarction Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

the second affiliated hospital of Zhejiang University

Hangzhou, China

Location status: Recruiting

Location contact

Min Lou

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 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;

Treatment and study plan

Early aspirin Therapy

Drug

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.

Non-Early aspirin Therapy

Drug

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

Primary outcomes

  1. The proportion of patients with modified Rankin scale (mRS) ≤2

    Time frame: 90 days

    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)].

Secondary outcomes

  1. Hemorrhage enlargement after intravenous thrombolysis

    Time frame: 7 days

    Hemorrhage enlargement after intravenous thrombolysis at 7 days

  2. Hemorrhage reduction after intravenous thrombolysis

    Time frame: 7 days

    Hemorrhage reduction after intravenous thrombolysis at 7 days

  3. the progress of National Institute of Health Stroke Scale (NIHSS) scores

    Time frame: 7 days

    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)]

  4. the distribution of modified Rankin scale (mRS)

    Time frame: 90 days

    the distribution of modified Rankin scale (mRS) at 90 days, on which scores range from 0 (no neurologic deficit) to 6 (death)]

  5. Recurrence rate of acute ischemic stroke

    Time frame: 90 days

    Recurrence rate of acute ischemic stroke at 90 days

  6. Recurrence rate of cerebrovascular disease

    Time frame: 90 days

    Recurrence rate of cerebrovascular disease at 90 days

  7. Recurrence rate of acute ischemic stroke

    Time frame: 1 year

    Recurrence rate of acute ischemic stroke at 1 years

  8. Recurrence rate of cerebrovascular disease

    Time frame: 1 year

    Recurrence rate of cerebrovascular disease at 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Min Lou, PhD

CONTACT

[email protected]

+8657187784810

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

  • Affiliated Hospital of Jiaxing University
  • Huzhou Central Hospital
  • Jinhua Central Hospital
  • Lishui Country People's Hospital
  • Ningbo Medical Center Lihuili Hospital
  • Ningbo No.2 Hospital
  • Shaoxing People's Hospital
  • Shenzhen Second People's Hospital
  • Taizhou Hospital
  • The Affiliated Hospital of Xuzhou Medical University
  • The Fourth Affiliated Hospital of Zhejiang University School of Medicine
  • The Second Affiliated Hospital of Jiaxing University
  • Wenzhou Central Hospital

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Nov 10, 2020
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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