Intravenous Tenecteplase Plus EVT Versus EVT Alone on 4.5 to 24 Hours After Basilar Artery Occlusion

Last updated: September 30, 2024
Sponsor: The First Affiliated Hospital of University of Science and Technology of China
Overall Status: Active - Recruiting

Phase

3

Condition

Stroke

Cerebral Ischemia

Treatment

Endovascular thrombectomy

Tenecteplase

Clinical Study ID

NCT05701956
ATTENTION LATE
  • Ages > 18
  • All Genders

Study Summary

To assess the effect of intravenous tenecteplase plus endovascular thrombectomy (EVT) compared to EVT alone on 4.5 to 24 hours after stroke due to basilar artery occlusion.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients presenting with posterior circulation ischemic stroke symptoms due tobasilar artery occlusion or vertebral artery occlusions that prevent antegrade flowinto the basilar artery;

  2. Time from stroke onset to randomization within 4.5-24 hours of estimated time ofbasilar artery occlusion;

  3. Patient's age≥18 years;

  4. Presence of basilar artery or vertebral artery occlusion, confirmed by CTAngiography (CTA), MR Angiography (MRA) or Digital Subtraction Angiography (DSA). Incases of vertebral artery occlusion, the occlusion must completely prevent antegradeflow 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 intravenousthrombolysis;

  6. Baseline National Institutes of Health Stroke Scale (NIHSS) score≥ 10 at the time ofneuroimaging;

  7. The patient or patient's legal representative signs the informed consent form.

Exclusion

Exclusion Criteria:

  1. CT or MR evidence of intracerebral hemorrhage (the presence of < 10 microbleeds isallowed);

  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 weightedimaging (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, whichwould 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, whichcannot be controlled by antihypertensive drugs;

  10. Genetic or acquired hemorrhagic diathesis, lack of anticoagulant factor; or oralanticoagulant with international normalized ratio (INR) > 1.7, or novel oralanticoagulant 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 aglomerular filtration rate <30 mL/min or the need for hemodialysis or peritonealdialysis;

  13. Patients who cannot complete 90-day follow-up (such as patients without fixedresidence, overseas patients, etc);

  14. The patient has acute ischemic cerebral infarction within 3 months fromrandomization;

  15. The patient had a history of or clinical suspicion for cerebral vasculitis orinfectious endocarditis;

  16. The patient has nervous system disease or mental disorder before stroke onset, whichmay affect the assessment of their condition;

  17. CT or MR examination showed large cerebellar infarction with obvious space occupyingeffect and compression of the fourth ventricle;

  18. Patients with extensive bilateral thalamic or extensive bilateral brainsteminfarction 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;

Study Design

Total Participants: 332
Treatment Group(s): 2
Primary Treatment: Endovascular thrombectomy
Phase: 3
Study Start date:
March 16, 2023
Estimated Completion Date:
March 31, 2026

Study Description

Background and Rationale: Recently, two prospective multicenter RCT (ATTENTION and BAOCHE trials) have shown a significantly beneficial effect of EVT in patients with an acute symptomatic basilar artery occlusion. The EXTEND-IA TNK trial demonstrated that intravenous thrombolysis with tenecteplase is superior to alteplase before EVT for anterior circulation large vessel occlusion strokes. However, it is unclear whether intravenous tenecteplase bridging with EVT is superior to EVT alone in the extended window patients with basilar artery occlusion. Therefore, additional studies are needed to explore the potential benefit of intravenous tenecteplase in these patients.

Study design: Multicenter, prospective, controlled clinical trial with open-label treatment and blind outcome assessment (PROBE) of intravenous tenecteplase plus EVT versus EVT alone. The trial has observer blinded assessment of the primary outcome and neuroimaging at baseline and follow up.

Connect with a study center

  • The First Affiliated Hospital of University of Science and Technology of China

    Hefei, Anhui 230001
    China

    Active - Recruiting

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