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

NCT ID: NCT04624295

Last Updated: 2025-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

294 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2026-06-30

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.

Detailed Description

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Conditions

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Antiplatelet Therapy Hemorrhagic Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Early Antiplatelet Therapy

Group Type ACTIVE_COMPARATOR

Early aspirin Therapy

Intervention Type 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 Antiplatelet Therapy

Group Type PLACEBO_COMPARATOR

Non-Early aspirin Therapy

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Acute ischemic patients receiving intravenous thrombolysis within 24 hours upon stroke onset
2. Be confirmed as Hemorrhagic Infarction at 24 to 36 hours after intravenous thrombolysis by computerized tomography
3. The patient or family member signed an informed consent

Exclusion Criteria

1. Early use of anticoagulant drugs within 1 week after intravenous thrombolysis;
2. Tirofiban was used after receiving endovascular treatment;
3. Intraoperative stent placement after receiving endovascular treatment;
4. Subarachnoid hemorrhage or ventricular hemorrhage;
5. There are contraindications for aspirin use;
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shaoxing People's Hospital

OTHER

Sponsor Role collaborator

Affiliated Hospital of Jiaxing University

OTHER

Sponsor Role collaborator

Huzhou Central Hospital

OTHER

Sponsor Role collaborator

The Second Affiliated Hospital of Jiaxing University

OTHER

Sponsor Role collaborator

Jinhua Central Hospital

OTHER

Sponsor Role collaborator

Taizhou Hospital

OTHER

Sponsor Role collaborator

Ningbo Medical Center Lihuili Hospital

OTHER_GOV

Sponsor Role collaborator

Ningbo No.2 Hospital

OTHER

Sponsor Role collaborator

Lishui Country People's Hospital

OTHER

Sponsor Role collaborator

Wenzhou Central Hospital

OTHER

Sponsor Role collaborator

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

OTHER

Sponsor Role collaborator

Shenzhen Second People's Hospital

OTHER

Sponsor Role collaborator

The Affiliated Hospital of Xuzhou Medical University

OTHER

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Min Lou, PhD

Role: STUDY_DIRECTOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

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the second affiliated hospital of Zhejiang University

Hangzhou, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Min Lou, PhD

Role: CONTACT

+8657187784810

Facility Contacts

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Min Lou

Role: primary

Other Identifiers

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HITs

Identifier Type: -

Identifier Source: org_study_id

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