Comparing two treatments for basilar artery occlusive stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the efficacy and safety of intravenous thrombolysis (IVT) followed by endovascular treatment (EVT) against EVT alone in patients suffering from acute ischemic stroke caused by basilar artery occlusion. The study will be conducted as a multicenter, prospective, open-label, blinded endpoint evaluation, randomized controlled trial. It seeks to address the current lack of direct comparisons between these two treatment strategies, which have shown varying results in previous studies. By enrolling eligible patients within 4.5 hours of symptom onset, the trial will provide valuable insights into the best treatment approach for this severe condition.

Why it matters

Who can join: the full rules

Inclusion criteria:

1. A clinical diagnosis of AIS.
2. Caused by BAO confirmed by CTA, MRA, or DSA. (BAO is defined as the absence of visualization of the basilar artery on CTA, MRA or DSA. Bilateral vertebral artery occlusions or occlusion of a unilateral vertebral artery that is the sole supplier of the basilar artery, even in the presence of patent basilar artery, will be considered de facto BAO.)
3. CT or MRI ruling out intracranial hemorrhage,
4. Eligible for IVT and EVT (within 4.5 hours of symptom onset). (Symptoms onset is defined as point in time the patient was last seen well \[at baseline\] if patients are unable to provide a reliable history or the point in time when symptoms have started if patients can provide a reliable history. Symptoms onset includes diplopia, midline ataxia, visual loss, sensory or motor deficits, and conscious disturbance. Isolated vertigo \[not accompanied by dysarthria, motor weakness, sensory symptoms, double vision, depressed level of consciousness\] is not considered onset of symptoms.)
5. NIHSS score ≥ 6.
6. Age ≥ 18 years.
7. Signed informed consent by the patient or legal representative.

Exclusion criteria:

1. mRS score \> 2 before this stroke.
2. Any contraindication to IVT as per the 2019 AHA/ASA guidelines for early management of AIS:

1) Blood pressure \> 185/110 mmHg and cannot be controlled by standard medication, 2) Blood glucose \< 50mg/dL (2.8 mmol/L) or \> 400mg/dL (22.2 mmol/L), 3) Had a cerebral infarction in the previous 6 weeks with residual neurological deficit or signs of recent infarction on neuroimaging, 4) Severe head trauma in the previous 3 months, 5) Major surgery or severe trauma in the previous 2 weeks, 6) Gastrointestinal or urinary bleeding in the previous 3 weeks, 7) previous intracranial hemorrhage, 8) Using anticoagulants and International normalized ratio (INR) \> 1.7, 9) Known platelet count \< 100 × 109/L, 10) treatment with direct thrombin or factor X inhibitors, 11) Heparin treatment in the previous 48 hours with the activated partial thromboplastin time (APTT) exceeding the upper limit of normal.

(3) Pregnancy, breastfeeding, or intention to conceive during the study period. (4) Other conditions deemed unsuitable by the investigator.

Where it's running

• Banan Hospital Affiliated to Chongqing Medical University
  Chongqing, Chongqing, China Recruiting
• Chongqing University Affiliated S Central Hospital
  Chongqing, Chongqing, China Recruiting
• Chongqing University Medical University Affiliated Yongchuan Hospital
  Chongqing, Chongqing, China Recruiting
• Liangping District People's Hospital
  Chongqing, Chongqing, China Recruiting
• Zhangzhou Hospital
  Zhangzhou, Fujian, China Recruiting
• Maoming County Traditional Chinese Medicine Hospital
  Maoming, Guangdong, China Recruiting

+35 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Fu-Qiang Guo, M.D. — Sichuan Academy of Medical Sciences
• Study coordinator: Fu-Qiang Guo, M.D.
• Email: guofuqiang2005@126.com
• Phone: +8618981838913

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Sevoflurane vs. Propofol for anesthesia in stroke patients undergoing clot-removal

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  Recruiting Phase 3 Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Barcelona · NCT07902791

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.