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Taking people in ChinaPhase 4

Early Aspirin After Bleeding in the Brain Following Stroke Clot-Dissolving Treatment

Tests early aspirin in adults with a stroke and bleeding after clot-dissolving treatment.

Key facts

Who runs it
Second Affiliated Hospital, Zhejiang University, School of Medicine
Where
Hangzhou, ChinaSee the site
Trial code
Registry title
Early Antiplatelet Therapy After Hemorrhagic Infarction in Acute Ischemic Stroke Treated With Intravenous Thrombolysis (HITs)
Status
Recruiting
Phase
Phase 4
People taking part
294 people, planned
Started
1 Jan 2021
Planned end
30 Jun 2026
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Early aspirin Therapy
  • Non-Early aspirin Therapy
Record updated
15 June 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who had a stroke caused by a blocked blood vessel, were treated with a clot-dissolving drug through a vein, and then showed bleeding within the damaged brain area on a CT scan.

Sex
Men and women can join.
Disease stage
Stroke caused by a blocked blood vessel (acute ischemic stroke), treated with intravenous thrombolysis within 24 hours of stroke onset. A CT scan 24 to 36 hours later must confirm hemorrhagic infarction.
Earlier treatment
Must have had intravenous thrombolysis within 24 hours of stroke onset. Cannot have used anticoagulant drugs within 1 week after thrombolysis.

Main reasons for not taking part

  • Anticoagulant drugs used within 1 week after intravenous thrombolysis
  • Tirofiban used after endovascular treatment
  • Stent placed during endovascular treatment
  • Subarachnoid hemorrhage or ventricular hemorrhage
  • Reasons why aspirin cannot be used

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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 take part

  • 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

Where in China

  • The Second Affiliated Hospital of Zhejiang UniversityHangzhou, ChinaContact: Min LouTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Early Antiplatelet TherapyExisting treatment, for comparison

    Treatment: Early aspirin Therapy

  • Non-Early Antiplatelet TherapyPlacebo, for comparison

    Treatment: Non-Early aspirin Therapy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Early Antiplatelet Therapy After Hemorrhagic Infarction in Acute Ischemic Stroke Treated With Intravenous Thrombolysis in China (HITs)：a Randomized Clinical Trial
Plain-language title
Early Aspirin After Bleeding in the Brain Following Stroke Clot-Dissolving TreatmentGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
15 June 2025