Combining Edaravone Dexborneol with thrombolysis for acute ischemic stroke treatment
A Multicenter, Randomized, Controlled Study of Rt-PA Thrombolysis Combined With Edaravone Dexborneol in Reducing Hemorrhagic Transformation in Patients With Acute Ischemic Stroke
This study is testing if adding Edaravone Dexborneol to a common stroke treatment can help people with acute ischemic stroke have better outcomes and less bleeding.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The Second Hospital of Hebei Medical University Academic / other |
| Locations | 1 site (Shijiazhuang, Hebei) |
| Trial ID | NCT06248242 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized, controlled study investigates the effects of Edaravone Dexborneol when combined with recombinant tissue-type plasminogen activator (rt-PA) in patients experiencing acute ischemic stroke. The study aims to reduce the incidence of bleeding transformation after thrombolysis and improve patient outcomes by protecting the blood-brain barrier and enhancing early recanalization rates. By dynamically monitoring changes related to bleeding transformation, the research seeks to elucidate the mechanisms by which Edaravone Dexborneol may mitigate complications associated with thrombolytic therapy.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with acute ischemic stroke who present with symptoms within 4.5 hours and have a neurological deficit score of 4 or higher.
Not a fit: Patients with a history of intracranial hemorrhage, severe infections, or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the safety and efficacy of thrombolytic treatment for acute ischemic stroke patients.
How similar studies have performed: While the combination of Edaravone Dexborneol with thrombolytic therapy is a novel approach, previous studies have shown promise in reducing complications associated with thrombolysis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. All patients met the diagnostic criteria of the Chinese acute ischemic stroke diagnosis and treatment guidelines. 2. Patients developed clinical symptoms for the first time, with an onset time of less than 4.5 hours. 3. Patients with the National Institutes of Health Stroke Scale (NIHSS) neurological deficit score was ≥4. 4. The study was approved by the hospital's theoretical committee and the patients provided consent. Exclusion Criteria: 1. Patients were allergic to the drugs used in this study. 2. Patients with a history of intracranial hemorrhage or subarachnoid hemorrhage, a recent history of head trauma, myocardial infarction, hemorrhage, and major surgical surgery 3. Patients with cerebral hemorrhage and large-area imaging cerebral infarction characteristics 4. Patients with severe infection, immune system and blood system diseases 5. Patients with severe injury to other important organs 6. Patients with severe coma or mental disorders 7. Patients undergoing surgical treatment within 2 weeks
Where this trial is running
Shijiazhuang, Hebei
- The Second Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Recruiting)
Study contacts
- Study coordinator: Guojun Tan, Dr
- Email: tandyshine@163.com
- Phone: 15803210587
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.