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

Phase 4

Recruiting

• Conditions: Antiplatelet Therapy; Hemorrhagic Infarction
• Interventions: Drug: Non-Early aspirin Therapy; Drug: Early aspirin Therapy

• Registration Number: NCT04624295
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-29
• Study First Submitted QC: 2020-11-05
• Study First Posted: 2020-11-10
• Study Start: 2021-01-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 294

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-Early Antiplatelet Therapy	Non-Early aspirin Therapy	-
Early Antiplatelet Therapy	Early aspirin Therapy	-

Primary Outcome Measures

Name	Time	Method
The proportion of patients with modified Rankin scale (mRS) ≤2	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 Outcome Measures

Name	Time	Method
Hemorrhage volume enlargement after intravenous thrombolysis	7 days	Hemorrhage volume enlargement after intravenous thrombolysis at 7 days
Hemorrhage volume reduction after intravenous thrombolysis	7 days	Hemorrhage volume reduction after intravenous thrombolysis at 7 days
the progress of National Institute of Health Stroke Scale (NIHSS) scores	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)\]
Enlarged infarct volume within 7 days	7 days	Enlarged infarct volume within 7 days
the distribution of modified Rankin scale (mRS)	90 days	the distribution of modified Rankin scale (mRS) at 90 days, on which scores range from 0 (no neurologic deficit) to 6 (death)\]
Recurrence rate of acute ischemic stroke	1 year	Recurrence rate of acute ischemic stroke at 1 years
Recurrence rate of cerebrovascular disease	1 year	Recurrence rate of cerebrovascular disease at 1 year

Trial Locations

Locations (1)

the second affiliated hospital of Zhejiang University; 🇨🇳 Hangzhou, China