Clinical trial NCT04624295: Early Antiplatelet Therapy After Hemorrhagic Infarction in Acute Ischemic Stroke Treated With Intravenous Thrombolysis (HITs)
Official title: Early Antiplatelet Therapy After Hemorrhagic Infarction in Acute Ischemic Stroke Treated With Intravenous Thrombolysis in China (HITs)：a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Antiplatelet Therapy
Hemorrhagic Infarction
Keywords: acute ischemic stroke
intravenous thrombolysis
Hemorrhagic Infarction
antiplatelet therapy
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Shaoxing People's Hospital
name: Affiliated Hospital of Jiaxing University
name: Huzhou Central Hospital
name: The Second Affiliated Hospital of Jiaxing University
name: Jinhua Central Hospital
name: Taizhou Hospital
name: Ningbo Medical Center Lihuili Hospital
name: Ningbo No.2 Hospital
name: Lishui Country People's Hospital
name: Wenzhou Central Hospital
name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
name: Shenzhen Second People's Hospital
name: The Affiliated Hospital of Xuzhou Medical University
First posted: 2020-11-10
Enrollment: 294
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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;

Primary outcomes:
measure: The proportion of patients with modified Rankin scale (mRS) ≤2
timeFrame: 90 days
Secondary outcomes:
measure: Hemorrhage enlargement after intravenous thrombolysis
timeFrame: 7 days
measure: Hemorrhage reduction after intravenous thrombolysis
timeFrame: 7 days
measure: the progress of National Institute of Health Stroke Scale (NIHSS) scores
timeFrame: 7 days
measure: the distribution of modified Rankin scale (mRS)
timeFrame: 90 days
measure: Recurrence rate of acute ischemic stroke
timeFrame: 90 days
measure: Recurrence rate of cerebrovascular disease
timeFrame: 90 days
measure: Recurrence rate of acute ischemic stroke
timeFrame: 1 year
measure: Recurrence rate of cerebrovascular disease
timeFrame: 1 year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the second affiliated hospital of Zhejiang University
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Min Lou, PhD
role: STUDY_DIRECTOR
References: