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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04624295

Collaborator

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

290

Enrollment

Location

Arms

43.9

Anticipated Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Antiplatelet Therapy Hemorrhagic Infarction	Drug: Early aspirin Therapy Drug: Non-Early aspirin Therapy	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

290 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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 [90 days]
Recurrence rate of acute ischemic stroke at 90 days
Recurrence rate of cerebrovascular disease [90 days]
Recurrence rate of cerebrovascular disease at 90 days
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Acute ischemic patients receiving intravenous thrombolysis within 4.5 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