Back to resultsEarly Antiplatelet Therapy After Hemorrhagic Infarction in Acute Ischemic Stroke Treated With Intravenous Thrombolysis (HITs)
Primary Purpose
Antiplatelet Therapy, Hemorrhagic Infarction
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Early aspirin Therapy
Non-Early aspirin Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Antiplatelet Therapy focused on measuring acute ischemic stroke, intravenous thrombolysis, Hemorrhagic Infarction, antiplatelet therapy
Eligibility Criteria
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
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;
Sites / Locations
- the second affiliated hospital of Zhejiang UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Early Antiplatelet Therapy
Non-Early Antiplatelet Therapy
Arm Description
Outcomes
Primary Outcome Measures
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)].
Secondary Outcome Measures
Hemorrhage volume enlargement after intravenous thrombolysis
Hemorrhage volume enlargement after intravenous thrombolysis at 7 days
Hemorrhage volume reduction after intravenous thrombolysis
Hemorrhage volume reduction after intravenous thrombolysis at 7 days
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)]
Enlarged infarct volume within 7 days
Enlarged infarct volume within 7 days
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)]
Recurrence rate of acute ischemic stroke
Recurrence rate of acute ischemic stroke at 90 days
Recurrence rate of cerebrovascular disease
Recurrence rate of cerebrovascular disease at 90 days
Recurrence rate of acute ischemic stroke
Recurrence rate of acute ischemic stroke at 1 years
Recurrence rate of cerebrovascular disease
Recurrence rate of cerebrovascular disease at 1 year
Full Information
NCT ID
NCT04624295
First Posted
October 29, 2020
Last Updated
May 5, 2022
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Shaoxing People's Hospital, Affiliated Hospital of Jiaxing University, Huizhou Municipal 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
1. Study Identification
Unique Protocol Identification Number
NCT04624295
Brief Title
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
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Shaoxing People's Hospital, Affiliated Hospital of Jiaxing University, Huizhou Municipal 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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antiplatelet Therapy, Hemorrhagic Infarction
Keywords
acute ischemic stroke, intravenous thrombolysis, Hemorrhagic Infarction, antiplatelet therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
290 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early Antiplatelet Therapy
Arm Type
Active Comparator
Arm Title
Non-Early Antiplatelet Therapy
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Early aspirin Therapy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Non-Early aspirin Therapy
Intervention Description
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 Measure Information:
Title
The proportion of patients with modified Rankin scale (mRS) ≤2
Description
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)].
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Hemorrhage volume enlargement after intravenous thrombolysis
Description
Hemorrhage volume enlargement after intravenous thrombolysis at 7 days
Time Frame
7 days
Title
Hemorrhage volume reduction after intravenous thrombolysis
Description
Hemorrhage volume reduction after intravenous thrombolysis at 7 days
Time Frame
7 days
Title
the progress of National Institute of Health Stroke Scale (NIHSS) scores
Description
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)]
Time Frame
7 days
Title
Enlarged infarct volume within 7 days
Description
Enlarged infarct volume within 7 days
Time Frame
7 days
Title
the distribution of modified Rankin scale (mRS)
Description
the distribution of modified Rankin scale (mRS) at 90 days, on which scores range from 0 (no neurologic deficit) to 6 (death)]
Time Frame
90 days
Title
Recurrence rate of acute ischemic stroke
Description
Recurrence rate of acute ischemic stroke at 90 days
Time Frame
90 days
Title
Recurrence rate of cerebrovascular disease
Description
Recurrence rate of cerebrovascular disease at 90 days
Time Frame
90 days
Title
Recurrence rate of acute ischemic stroke
Description
Recurrence rate of acute ischemic stroke at 1 years
Time Frame
1 year
Title
Recurrence rate of cerebrovascular disease
Description
Recurrence rate of cerebrovascular disease at 1 year
Time Frame
1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Lou, PhD
Phone
+8657187784810
Email
loumingxc@vip.sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Lou, PhD
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Study Director
Facility Information:
Facility Name
the second affiliated hospital of Zhejiang University
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Lou
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Early Antiplatelet Therapy After Hemorrhagic Infarction in Acute Ischemic Stroke Treated With Intravenous Thrombolysis (HITs)
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