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

Antiplatelet Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04624295
• Other study ID #: HITs
• Status: Recruiting
• Phase: Phase 4
• Start date: November 1, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Min Lou, PhD
• Phone: +8657187784810
• Email: loumingxc[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 290
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Acute ischemic patients receiving intravenous thrombolysis within 4.5 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;

Related Conditions & MeSH terms

• Antiplatelet Therapy
• Hemorrhagic Infarction
• Infarction
• Ischemic Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	the second affiliated hospital of Zhejiang University	Hangzhou

Sponsors (14)

Lead Sponsor

Collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

First Affiliated Hospital of Jiaxing University, Huizhou Municipal Central Hospital, Jinhua Central Hospital, Lishui Country People's Hospital, Ningbo Medical Center Lihuili Hospital, Ningbo No.2 Hospital, Shaoxing People's Hospital, Shenzhen Second People's Hospital, Taizhou Hospital, The Affiliated Hospital of Xuzhou Medical University, The Fourth Affiliated Hospital of Zhejiang University School of Medicine, The Second Affiliated Hospital of Jiaxing University, Wenzhou Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hemorrhage volume enlargement after intravenous thrombolysis	Hemorrhage volume enlargement after intravenous thrombolysis at 7 days	7 days
Secondary	Hemorrhage volume reduction after intravenous thrombolysis	Hemorrhage volume reduction after intravenous thrombolysis at 7 days	7 days
Secondary	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
Secondary	Enlarged infarct volume within 7 days	Enlarged infarct volume within 7 days	7 days
Secondary	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
Secondary	Recurrence rate of acute ischemic stroke	Recurrence rate of acute ischemic stroke at 90 days	90 days
Secondary	Recurrence rate of cerebrovascular disease	Recurrence rate of cerebrovascular disease at 90 days	90 days
Secondary	Recurrence rate of acute ischemic stroke	Recurrence rate of acute ischemic stroke at 1 years	1 year
Secondary	Recurrence rate of cerebrovascular disease	Recurrence rate of cerebrovascular disease at 1 year	1 year