Endovascular Thrombectomy Alone Versus Intravenous Thrombolysis Plus Thrombectomy on Acute Basilar Artery Occlusion

NCT05827042 | Recruiting Phase 3 DMC

• 1 other identifier: ATTENTION IV
• Study Type: interventional
• Target: 338
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the effect of endovascular thrombectomy alone compared to intravenous thrombolysis plus endovascular thrombectomy in acute basilar artery occlusion patients within 4.5 hours from onset on efficacy and safety outcomes.

Conditions

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

Keywords

Thrombectomy; thrombolysis

Outcome Measures

Primary Outcomes (1)

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

  The modified Rankin Score is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability.

  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

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

  90 (± 14 days) after procedure

• Proportion of patients with modified Rankin Score 0-4 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 National Institute of Health Stroke Scale (NIHSS) at 24 hours

  24 hours after procedure

Other Outcomes (3)

• Symptomatic intracerebral hemorrhage (sICH) within 72 hours

  Within 72 hours after procedure

• Any intracerebral hemorrhage within 72 hours

  Within 72 hours after procedure

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

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

Study Arms (2)

Endovascular thrombectomy alone

EXPERIMENTAL

Patients will receive endovascular thrombectomy without intravenous thrombolysis.

Procedure: Endovascular thrombectomy

Intravenous thrombolysis plus endovascular thrombectomy

ACTIVE COMPARATOR

Patients will receive intravenous alteplase (0.9mg/kg, maximum 90mg) or tenecteplase (0.25mg/kg, maximum 25mg) before endovascular thrombectomy.

Drug: Intravenous thrombolysis; Procedure: Endovascular thrombectomy

Interventions

Intravenous thrombolysis DRUG

Patients will receive intravenous alteplase (0.9mg/kg, maximum 90mg) or tenecteplase (0.25mg/kg, maximum 25mg) before endovascular thrombectomy.

Also known as: Alteplase or Tenecteplase

Intravenous thrombolysis plus endovascular thrombectomy

Endovascular thrombectomy PROCEDURE

Endovascular thrombectomy

Endovascular thrombectomy alone; Intravenous thrombolysis plus 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 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 case of vertebral artery occlusion, the occlusion must completely prevent antegrade flow into the basilar artery;
• Patients presenting with acute ischemic stroke eligible to receive both endovascular thrombectomy and intravenous thrombolysis using standard criteria;
• Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 10;
• 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 ≥ 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, anatomical 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 can not be controlled by antihypertensive drugs;
• Genetic or acquired hemorrhagic diathesis, lack of anticoagulant factor; 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), glomerular filtration rate \<30 mL/min, 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

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Tissue Plasminogen Activator; Tenecteplase

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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; Biological Factors

Study Officials

• Wei Hu, MD

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

  STUDY CHAIR

Central Study Contacts

Wei Hu, MD

CONTACT

+8615155510611; andinghu@ustc.edu.cn

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: SPONSOR

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: April 24, 2023
• Study Start: May 9, 2023
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: October 1, 2024

Record last verified: 2024-08

Locations

CN (1)