Antiplatelet Therapy, Hemorrhagic Infarction
Conditions
Keywords
acute ischemic stroke, intravenous thrombolysis, Hemorrhagic Infarction, antiplatelet therapy
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.
Interventions
DRUGEarly 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.
DRUGNon-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.
Sponsors
Shaoxing People's Hospital
Affiliated Hospital of Jiaxing University
Huzhou Central Hospital
The Second Affiliated Hospital of Jiaxing University
Jinhua Central Hospital
Taizhou Hospital
Ningbo Medical Center Lihuili Hospital
Ningbo No.2 Hospital
Lishui Country People's Hospital
Wenzhou Central Hospital
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Shenzhen Second People's Hospital
The Affiliated Hospital of Xuzhou Medical University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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)\] |
| 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)\] |
| Hemorrhage reduction after intravenous thrombolysis | 7 days | Hemorrhage reduction after intravenous thrombolysis at 7 days |
| 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 |
| Hemorrhage enlargement after intravenous thrombolysis | 7 days | Hemorrhage enlargement after intravenous thrombolysis at 7 days |
Countries
China
Contacts
Primary ContactMin Lou, PhD
Outcome results
None listed