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

Zhejiang University

Status and phase: Enrolling; Phase 4

Conditions: Hemorrhagic Infarction; Antiplatelet Therapy

Treatments: Drug: Early aspirin Therapy; Drug: Non-Early aspirin Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04624295

HITs

Details and patient eligibility

About

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.

Enrollment: 294 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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294 participants in 2 patient groups, including a placebo group

Early Antiplatelet Therapy

Active Comparator group

Treatment:

Drug: Early aspirin Therapy

Non-Early Antiplatelet Therapy

Placebo Comparator group

Treatment:

Drug: Non-Early aspirin Therapy