Early Antiplatelet Therapy After Hemorrhagic Infarction in Acute Ischemic Stroke Treated With Intravenous Thrombolysis (HITs)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Early aspirin Therapy, Non-Early aspirin Therapy.
- Who it may be relevant to
- Registry conditions: Antiplatelet Therapy, Hemorrhagic Infarction. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Early Antiplatelet Therapy After Hemorrhagic Infarction in Acute Ischemic Stroke Treated With Intravenous Thrombolysis in China (HITs)：a Randomized Clinical Trial
Overview
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
- 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. - 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.
Primary outcome measures
- The proportion of patients with modified Rankin scale (mRS) ≤2 [Time frame: 90 days]
Secondary outcome measures (8)
- Hemorrhage enlargement after intravenous thrombolysis [Time frame: 7 days]
- Hemorrhage reduction after intravenous thrombolysis [Time frame: 7 days]
- the progress of National Institute of Health Stroke Scale (NIHSS) scores [Time frame: 7 days]
- the distribution of modified Rankin scale (mRS) [Time frame: 90 days]
- Recurrence rate of acute ischemic stroke [Time frame: 90 days]
- Recurrence rate of cerebrovascular disease [Time frame: 90 days]
- Recurrence rate of acute ischemic stroke [Time frame: 1 year]
- Recurrence rate of cerebrovascular disease [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- Acute ischemic patients receiving intravenous thrombolysis within 24 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
Exclusion criteria
- Early use of anticoagulant drugs within 1 week after intravenous thrombolysis;
- Tirofiban was used after receiving endovascular treatment;
- Intraoperative stent placement after receiving endovascular treatment;
- Subarachnoid hemorrhage or ventricular hemorrhage;
- There are contraindications for aspirin use;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- the second affiliated hospital of Zhejiang University — Hangzhou
Identifiers
NCT: NCT04624295 · HITs