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NCT05701956CompletedPhase 3

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

Source: ClinicalTrials.gov · Last updated 18 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
330 (actual)
First submitted
18 Jan 2023
Start date
16 Mar 2023
Primary completion date
4 Feb 2025
Lead sponsor
The First Affiliated Hospital of University of Science and Technology of China
Diseases
Stroke
NCT number
NCT05701956

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 330
  • From 16 Mar 2023 to the primary completion date, 4 Feb 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg, which cannot be controlled by antihypertensive drugs;
  • Patients who received intravenous thrombolytics treatment before the randomization;

Other illness

  • CT or MR evidence of intracerebral hemorrhage (the presence of \< 10 microbleeds is allowed);
  • Pre-stroke modified Rankin scale (mRS) score of ≥ 2;
  • 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;
  • Allergy to contrast agent or nitinol alloy;
  • The patient had a history of or clinical suspicion for cerebral vasculitis or infectious endocarditis;
  • The patient has nervous system disease or mental disorder before stroke onset, which may affect the assessment of their condition;

Lab values

  • 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;
  • Blood glucose \<50 mg/dl (2.8 mmol/L) or \>400 mg/dl (22.2 mmol/L), platelet\< 100\*109/L;
  • 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;

Other

  • Pregnant or lactating women;
  • Life expectancy\<1 year;
  • CTA/MRA/DSA show vascular tortuosity, vascular variation or artery dissection, which would make it difficult to perform endovascular treatment;
  • Participating in other clinical trials;
  • Patients who cannot complete 90-day follow-up (such as patients without fixed residence, overseas patients, etc);
  • The patient has acute ischemic cerebral infarction within 3 months from randomization;
  • CT or MR examination showed large cerebellar infarction with obvious space occupying effect and compression of the fourth ventricle;
  • Patients with extensive bilateral thalamic or extensive bilateral brainstem infarction on CT or MR examination;
  • CTA/MRA/DSA show both anterior and posterior circulation large vessel occlusion;
  • Patients with intracranial tumors (except small meningiomas);

Who the study is looking for

  • 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;
  • Time from stroke onset to randomization within 4.5-24 hours of estimated time of basilar artery occlusion;
  • Patient's age≥18 years;
  • 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;
  • Patients presenting with acute ischemic stroke eligible using standard criteria (except for time window) to receive both endovascular thrombectomy and intravenous thrombolysis;
  • Baseline National Institutes of Health Stroke Scale (NIHSS) score≥ 10 at the time of neuroimaging;
  • The patient or patient's legal representative signs the informed consent form.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital of University of Science and Technology of China
Coordinator of this site? Confirm its status
HefeiChinaUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.