Antiplatelet TherapyPhase 4NCT04624295
Early Antiplatelet Therapy After Hemorrhagic Infarction in Acute Ischemic Stroke Treated With Intravenous Thrombolysis (HITs)
A Phase 4 study testing Early aspirin Therapy and Non-Early aspirin Therapy in people with Antiplatelet Therapy and Hemorrhagic Infarction, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Antiplatelet Therapy, Hemorrhagic Infarction
- What is being tested?
- Early aspirin Therapy and Non-Early aspirin Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 294 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 30 Jun 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the second affiliated hospital of Zhejiang University
Hangzhou
Min Lou
About this study
Official title: Early Antiplatelet Therapy After Hemorrhagic Infarction in Acute Ischemic Stroke Treated With Intravenous Thrombolysis in China (HITs)：a Randomized Clinical Trial
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.
- Conditions
- Antiplatelet Therapy, Hemorrhagic Infarction
- Being tested
- Early aspirin Therapy, Non-Early aspirin Therapy
- Keywords
- acute ischemic stroke, intravenous thrombolysis, Hemorrhagic Infarction, antiplatelet therapy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early aspirin TherapyDrug
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.
Non-Early aspirin TherapyDrug
Antiplatelet therapy will be delayed to beyond 48 hours after stroke onset and may not be initiated until hemorrhagic Infarction has been confirmed absorbed.
| Study group | Role | What they receive |
|---|---|---|
| Early Antiplatelet Therapy | Active comparator | Not described Receives: Drug: Early aspirin Therapy |
| Non-Early Antiplatelet Therapy | Placebo comparator | Not described Receives: Drug: Non-Early aspirin Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)].
Measured: 90 days
Secondary outcomes (8)
Hemorrhage enlargement after intravenous thrombolysis
Hemorrhage enlargement after intravenous thrombolysis at 7 days
Measured: 7 days
Hemorrhage reduction after intravenous thrombolysis
Hemorrhage reduction after intravenous thrombolysis at 7 days
Measured: 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)]
Measured: 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)]
Measured: 90 days
Recurrence rate of acute ischemic stroke
Recurrence rate of acute ischemic stroke at 90 days
Measured: 90 days
Recurrence rate of cerebrovascular disease
Recurrence rate of cerebrovascular disease at 90 days
Measured: 90 days
Recurrence rate of acute ischemic stroke
Recurrence rate of acute ischemic stroke at 1 years
Measured: 1 year
Recurrence rate of cerebrovascular disease
Recurrence rate of cerebrovascular disease at 1 year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start1 Jan 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antiplatelet TherapyStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 294 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
- Investigators
- Min Lou, PhD, Study director, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04624295
- Sponsor's protocol ID
- HITs
- Status last verified
- May 2025
- First submitted
- 29 Oct 2020
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Antiplatelet Therapy After Hemorrhagic Infarction in Acute Ischemic Stroke Treated With Intravenous Thrombolysis in China (HITs)：a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04624295
- Acronym / sponsor ID
- HITs
- Conditions
- Antiplatelet Therapy, Hemorrhagic Infarction
- Keywords
- acute ischemic stroke, intravenous thrombolysis, Hemorrhagic Infarction, antiplatelet therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- 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
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 10 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Antiplatelet Therapy | Active comparator | Drug: Early aspirin Therapy |
| Non-Early Antiplatelet Therapy | Placebo comparator | Drug: Non-Early aspirin Therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early aspirin TherapyEarly 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 | Early Antiplatelet Therapy |
| Non-Early aspirin TherapyAntiplatelet therapy will be delayed to beyond 48 hours after stroke onset and may not be initiated until hemorrhagic Infarction has been confirmed absorbed. | Drug | Non-Early Antiplatelet Therapy |
Primary outcome
The proportion of patients with modified Rankin scale (mRS) ≤2
Time frame: 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)].
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Min Lou, PhD study director
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Early aspirin Therapy and Non-Early aspirin Therapy in people with Antiplatelet Therapy and Hemorrhagic Infarction, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min Lou, PhD (+8657187784810, loumingxc@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with modified Rankin scale (mRS) ≤2 (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.