Early antiplatelet therapy for stroke patients after hemorrhagic infarction
Early Antiplatelet Therapy After Hemorrhagic Infarction in Acute Ischemic Stroke Treated With Intravenous Thrombolysis in China (HITs)：a Randomized Clinical Trial
This study is testing if giving aspirin early to stroke patients who had a bleeding problem can help them recover better after treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 294 (estimated) |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou) |
| Trial ID | NCT04624295 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy and safety of early antiplatelet therapy, specifically aspirin, in patients who have experienced a hemorrhagic infarction following intravenous thrombolysis for acute ischemic stroke. Participants will be randomly assigned to receive either early or non-early aspirin therapy after confirming hemorrhagic infarction through CT imaging. The study aims to determine whether early intervention can improve outcomes for these patients, who are at risk of complications from their condition.
Who should consider this trial
Good fit: Ideal candidates include acute ischemic stroke patients who have received intravenous thrombolysis within 24 hours and have been confirmed to have a hemorrhagic infarction.
Not a fit: Patients who have contraindications for aspirin use or have received anticoagulant drugs within one week after thrombolysis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for stroke patients, potentially reducing complications associated with hemorrhagic infarction.
How similar studies have performed: Previous studies have shown mixed results regarding the relationship between hemorrhagic infarction and outcomes in stroke patients, making this approach both relevant and potentially novel.
Eligibility criteria
Show full inclusion / exclusion 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;
Where this trial is running
Hangzhou
- the second affiliated hospital of Zhejiang University — Hangzhou, China (Recruiting)
Study contacts
- Study coordinator: Min Lou, PhD
- Email: loumingxc@vip.sina.com
- Phone: +8657187784810
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.