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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

294 Participants
are divided into 2 treatment groups
Group A: Early Antiplatelet TherapyActive comparator 1 intervention
Group B: Non-Early Antiplatelet TherapyPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)\].

Time frame
90 days

Secondary outcomes

1

Hemorrhage enlargement after intravenous thrombolysis

Hemorrhage enlargement after intravenous thrombolysis at 7 days

Time frame
7 days
2

Hemorrhage reduction after intravenous thrombolysis

Hemorrhage reduction after intravenous thrombolysis at 7 days

Time frame
7 days
3

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)\]

Time frame
7 days
4

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)\]

Time frame
90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Shaoxing People's Hospital

Collaborator

Affiliated Hospital of Jiaxing University

Collaborator

Huzhou Central Hospital

Collaborator

The Second Affiliated Hospital of Jiaxing University

Collaborator

Jinhua Central Hospital

Collaborator

Taizhou Hospital

Collaborator

Ningbo Medical Center Lihuili Hospital

Collaborator

Ningbo No.2 Hospital

Collaborator

Lishui Country People's Hospital

Collaborator

Wenzhou Central Hospital

Collaborator

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Collaborator

Shenzhen Second People's Hospital

Collaborator

The Affiliated Hospital of Xuzhou Medical University

Collaborator