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

NCT05701956 | Completed Phase 3 DMC

• 1 other identifier: ATTENTION LATE
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Basilar Artery Occlusion; Acute Cerebrovascular Accident; Stroke Due to Basilar Artery Occlusion

Keywords

Thrombectomy; Tenecteplase; Mechanical Thrombectomy

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with modified Rankin Score 0-2 at day 90 (±14 days)

  modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)

  90 (± 14 days) after procedure

Secondary Outcomes (12)

• Proportion of patients with modified Rankin Score 0-3 at day 90 (±14 days)

  90 (± 14 days) after procedure

• Ordinal Shift analysis of modified Rankin Score at day 90 (±14 days)

  90 (± 14 days) after procedure

• Score on the NIHSS at 24 hours

  24 hours after procedure

• Score on the NIHSS at 5-7 days or discharge

  5-7 days or discharge after procedure

• Proportion of patients with modified Rankin Score 0-1 at day 90 (±14 days)

  90 (± 14 days) after procedure

Other Outcomes (3)

• Overall mortality at 7 (± 2 days) and 90 (± 14 days)

  7 (± 2 days) and 90 (± 14 days) after procedure

• Symptomatic intracerebral hemorrhage (sICH) within 72 hours

  Within 72 hours after procedure

• Any intracerebral hemorrhage within 72 hours

  Within 72 hours after procedure

Study Arms (2)

Intravenous tenecteplase+endovascular thrombectomy

EXPERIMENTAL

Patients will receive intravenous tenecteplase (0.25mg/kg, max 25mg) plus endovascular thrombectomy.

Drug: Tenecteplase; Procedure: Endovascular thrombectomy

Endovascular thrombectomy alone

ACTIVE COMPARATOR

Patients will receive endovascular thrombectomy alone.

Procedure: Endovascular thrombectomy

Interventions

Tenecteplase DRUG

Patients will receive intravenous tenecteplase (0.25mg/kg, maximum 25mg, administered as a bolus over 5-10 seconds) before endovascular thrombectomy

Also known as: TNK, TNK-tPA, TNKase, rhTNK-tPA

Intravenous tenecteplase+endovascular thrombectomy

Endovascular thrombectomy PROCEDURE

The choice of endovascular thrombectomy strategy will be made by the treating neurointerventionist. All thrombectomy devices for endovascular treatment, which are approved by CFDA for this purpose, are allowed in the trial.

Also known as: thrombectomy

Endovascular thrombectomy alone; Intravenous tenecteplase+endovascular thrombectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Pregnant or lactating women;
• Allergy to contrast agent or nitinol alloy;
• 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;
• Systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg, which cannot be controlled by antihypertensive drugs;
• 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;
• 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;
• The patient had a history of or clinical suspicion for cerebral vasculitis or infectious endocarditis;

Sponsors & Collaborators

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

Study Sites (1)

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

Hefei, Anhui, 230001, China

Location

MeSH Terms

Conditions

Stroke

Interventions

Tenecteplase; TNK-tissue plasminogen activator; Thrombectomy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tissue Plasminogen Activator; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Wei Hu, MD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: January 27, 2023
• Study Start: March 16, 2023
• Primary Completion: February 4, 2025
• Study Completion: May 4, 2025
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)