Comparing two treatments for acute ischemic stroke using a mobile stroke unit
Intravenous Tenecteplase Versus Alteplase for Acute Ischemic Stroke Treatment on Mobile Stroke Units, a Prospective Multicenter Randomized Controlled Trial
PHASE4 · Mahidol University · NCT06498323
This study is testing if a new stroke treatment called tenecteplase works better than the standard treatment, alteplase, for people having an acute ischemic stroke.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mahidol University (other) |
| Locations | 1 site (Bangkok) |
| Trial ID | NCT06498323 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of intravenous tenecteplase compared to the standard treatment of intravenous alteplase for patients experiencing acute ischemic stroke. The study is conducted in a multicenter format, utilizing mobile stroke units to provide timely treatment within 4.5 hours of symptom onset. Participants will be monitored for safety and efficacy outcomes to determine if tenecteplase offers advantages over alteplase in this acute setting. The trial aims to provide insights into optimizing thrombolytic therapy for stroke patients.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who have been diagnosed with acute ischemic stroke within 4.5 hours of symptom onset and have no contraindications for thrombolytic therapy.
Not a fit: Patients who have experienced stroke symptoms for more than 4.5 hours or have contraindications for thrombolytic drugs will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for acute ischemic stroke, potentially enhancing recovery and reducing disabilities.
How similar studies have performed: Previous studies have shown that tenecteplase is comparable in efficacy and safety to alteplase, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed as Acute ischemic stroke within 4.5 hr of symptom onset * Age \> 18 years old * No contraindication for thrombolytic drug * Informed consent from patients Exclusion Criteria: * Diagnosed as Acute ischemic stroke with more than 4.5 hours of symptom onset or uncontained onset * Have contraindication for thrombolytic drugs
Where this trial is running
Bangkok
- Siriraj Stroke Center,Siriraj Hospital — Bangkok, Thailand (RECRUITING)
Study contacts
- Study coordinator: Yongchai Nilanont
- Email: ynilanon@gmail.com
- Phone: 924245898
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.
Conditions: Intravenous, Thrombosis, Acute Ischemic Stroke, Acute ischemic stroke, Mobile stroke unit, Intravenous Tenecteplase