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

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

Study Overview

• Status: Recruiting
• Conditions: Antiplatelet Therapy; Hemorrhagic Infarction
• Intervention / Treatment: Drug: Early aspirin Therapy; Drug: Non-Early aspirin Therapy

• Study Type: Interventional
• Enrollment (Estimated): 294
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Min Lou, PhD; Phone Number: +8657187784810; Email: loumingxc@vip.sina.com

Study Locations

• China
  • Hangzhou, China
    • Recruiting
    • The Second Affiliated Hospital of Zhejiang University
    • Contact: Min Lou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Early Antiplatelet Therapy	Drug: 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.
Placebo Comparator: Non-Early Antiplatelet Therapy	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)].	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)]	7 days
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)]	90 days
Recurrence rate of acute ischemic stroke	Recurrence rate of acute ischemic stroke at 90 days	90 days
Recurrence rate of cerebrovascular disease	Recurrence rate of cerebrovascular disease at 90 days	90 days
Recurrence rate of acute ischemic stroke	Recurrence rate of acute ischemic stroke at 1 years	1 year
Recurrence rate of cerebrovascular disease	Recurrence rate of cerebrovascular disease at 1 year	1 year
Hemorrhage enlargement after intravenous thrombolysis	Hemorrhage enlargement after intravenous thrombolysis at 7 days	7 days
Hemorrhage reduction after intravenous thrombolysis	Hemorrhage reduction after intravenous thrombolysis at 7 days	7 days

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Ningbo Medical Center Lihuili Hospital; Shenzhen Second People's Hospital; Shaoxing People's Hospital; Wenzhou Central Hospital; Jinhua Central Hospital; The Affiliated Hospital of Xuzhou Medical University; Taizhou Hospital; Ningbo No.2 Hospital; The Second Affiliated Hospital of Jiaxing University; Lishui Country People's Hospital; The Fourth Affiliated Hospital of Zhejiang University School of Medicine; Affiliated Hospital of Jiaxing University; Huzhou Central Hospital
• Investigators: Study Director: Min Lou, PhD, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: October 29, 2020
• First Submitted That Met QC Criteria: November 5, 2020
• First Posted (Actual): November 10, 2020

Study Record Updates

• Last Update Posted (Actual): June 15, 2025
• Last Update Submitted That Met QC Criteria: June 11, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: acute ischemic stroke; antiplatelet therapy; intravenous thrombolysis; Hemorrhagic Infarction
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Necrosis; Ischemia; Stroke; Ischemic Stroke; Infarction; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Fibrin Modulating Agents; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Antipyretics; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Fibrinolytic Agents; Platelet Aggregation Inhibitors; Aspirin
• Other Study ID Numbers: HITs

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No