Combining Tenecteplase with Thrombectomy for Basilar Artery Occlusion

Intravenous Tenecteplase Plus Endovascular Thrombectomy Versus Endovascular Thrombectomy Alone on 4.5 to 24 Hours After Stroke Due to Basilar Artery Occlusion -a Multicenter, Randomized Controlled, Clinical Trial

This study is testing if adding a medication called tenecteplase to a procedure for removing blood clots can help people who have had a stroke from a blocked basilar artery recover better than with the procedure alone.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 332 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital of University of Science and Technology of China (Academic / other)
• Locations: 1 site (Hefei, Anhui)
• Trial ID: NCT05701956 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of intravenous tenecteplase combined with endovascular thrombectomy (EVT) compared to EVT alone in patients who have suffered a stroke due to basilar artery occlusion. It is a multicenter, prospective, controlled trial that employs an open-label treatment design with blinded outcome assessment. The study aims to determine if the addition of tenecteplase improves outcomes for patients treated within a 4.5 to 24-hour window after stroke onset. Participants will undergo neuroimaging assessments at baseline and follow-up to evaluate the primary outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who present with acute ischemic stroke symptoms due to basilar artery occlusion within the specified time frame.

Not a fit: Patients who do not have a confirmed basilar artery or vertebral artery occlusion or those with a baseline NIHSS score below 10 may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve recovery outcomes for patients suffering from basilar artery occlusion strokes.

How similar studies have performed: Previous studies, such as the ATTENTION and BAOCHE trials, have shown positive outcomes for EVT in similar patient populations, indicating potential for success with this approach.

Eligibility criteria

Inclusion Criteria:

1. Patients presenting with posterior circulation ischemic stroke symptoms due to basilar artery occlusion or vertebral artery occlusions that prevent antegrade flow into the basilar artery;
2. Time from stroke onset to randomization within 4.5-24 hours of estimated time of basilar artery occlusion;
3. Patient's age≥18 years;
4. Presence of basilar artery or vertebral artery occlusion, confirmed by CT Angiography (CTA), MR Angiography (MRA) or Digital Subtraction Angiography (DSA). In cases of vertebral artery occlusion, the occlusion must completely prevent antegrade flow into the basilar artery;
5. Patients presenting with acute ischemic stroke eligible using standard criteria (except for time window) to receive both endovascular thrombectomy and intravenous thrombolysis;
6. Baseline National Institutes of Health Stroke Scale (NIHSS) score≥ 10 at the time of neuroimaging;
7. The patient or patient's legal representative signs the informed consent form.

Exclusion Criteria:

1. CT or MR evidence of intracerebral hemorrhage (the presence of \< 10 microbleeds is allowed);
2. Pre-stroke modified Rankin scale (mRS) score of ≥ 2;
3. Posterior circulation Acute Stroke Prognosis Early CT Score (PC-ASPECTS) on CT/ CTA-Source Images\<6; PC-ASPECTS on magnetic resonance imaging-diffusion weighted imaging (MRI-DWI) \<5;
4. Pregnant or lactating women;
5. Allergy to contrast agent or nitinol alloy;
6. Life expectancy\<1 year;
7. CTA/MRA/DSA show vascular tortuosity, vascular variation or artery dissection, which would make it difficult to perform endovascular treatment;
8. Participating in other clinical trials;
9. Systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg, which cannot be controlled by antihypertensive drugs;
10. Genetic or acquired hemorrhagic diathesis, lack of anticoagulant factor; or oral anticoagulant with international normalized ratio (INR) \> 1.7, or novel oral anticoagulant within prior 48 hours;
11. Blood glucose \<50 mg/dl (2.8 mmol/L) or \>400 mg/dl (22.2 mmol/L), platelet\< 100\*109/L;
12. Renal insufficiency defined as serum creatinine \>2.0 mg/dl (or 176.8 μ mol/l) or a glomerular filtration rate \<30 mL/min or the need for hemodialysis or peritoneal dialysis;
13. Patients who cannot complete 90-day follow-up (such as patients without fixed residence, overseas patients, etc);
14. The patient has acute ischemic cerebral infarction within 3 months from randomization;
15. The patient had a history of or clinical suspicion for cerebral vasculitis or infectious endocarditis;
16. The patient has nervous system disease or mental disorder before stroke onset, which may affect the assessment of their condition;
17. CT or MR examination showed large cerebellar infarction with obvious space occupying effect and compression of the fourth ventricle;
18. Patients with extensive bilateral thalamic or extensive bilateral brainstem infarction on CT or MR examination;
19. CTA/MRA/DSA show both anterior and posterior circulation large vessel occlusion;
20. Patients with intracranial tumors (except small meningiomas);
21. Patients who received intravenous thrombolytics treatment before the randomization;

Where this trial is running

Hefei, Anhui

• The First Affiliated Hospital of University of Science and Technology of China — Hefei, Anhui, China (Recruiting)

Study contacts

• Study coordinator: Wei Hu, MD

Conditions Basilar Artery Occlusion; Acute Cerebrovascular Accident; Stroke Due to Basilar Artery Occlusion; Thrombectomy; Tenecteplase; Mechanical Thrombectomy