Intra-Arterial Tenecteplase Following Endovascular Thrombectomy for Large Vessel Occlusion Stroke

Phase 2

Not yet recruiting

• Conditions: Acute Ischemic Stroke
• Interventions: Drug: Intra-arterial Tenecteplase; Drug: Intra-arterial Saline

• Registration Number: NCT06781385
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

The purpose of this study is to determine the safety and feasibility of using intra-arterial Tenecteplase in patients undergoing blood clot extraction for treatment of acute ischemic (non-bleeding) stroke. Tenecteplase is a drug that is currently FDA-approved to treat a heart attack but not currently approved for stroke treatment.

Detailed Description

The primary objective of this study is to determine the safety and feasibility of intra-arterial Tenecteplase in selected patients with persistent post-thrombectomy hypoperfusion on computed tomography perfusion based on symptomatic intracranial hemorrhage (parenchymal hematoma type 2, subarachnoid hemorrhage, and/or intraventricular hemorrhage producing decline from the initial NIHSS of ≥ 4 points) at 24-36 hours.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2025-01-13
• Study First Submitted QC: 2025-01-13
• Study First Posted: 2025-01-17
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-18
• Study Start: 2025-05
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patient/legally authorized representative has signed the Informed Consent Form
• Ability to comply with the study protocol, in the investigator's judgment
• Functionally independent (modified Rankin scale 0-2) prior to presentation
• Baseline National Institutes of Health Stroke Scale (NIHSS) ≥ 6
• Clinical syndrome consistent with occlusion of the internal carotid artery (ICA) or proximal middle cerebral artery (MCA), presenting within 4.5- to 24-hours of TLKW
• Evidence of ICA, MCA-M1, or MCA-M2 occlusion on baseline computed tomography angiogram (CTA) or magnetic resonance angiogram (MRA). ICA/MCA tandem occlusions may be enrolled
• Alberta Stroke Program Early Computed Tomography Score ≥ 6 on pre-thrombectomy unenhanced CT as determined by treating neurologist or reading radiologist
• Pre-thrombectomy computed tomography perfusion (CTP) or magnetic resonance perfusion (MRP) with core infarction (cerebral blood flow < 30%) < 70 ml, mismatch ratio ≥ 1.8, mismatch volume ≥ 15 ml (completed within 120 minutes of skin puncture for thrombectomy)
• Endovascular thrombectomy of ICA, MCA-M1 or MCA-M2 occlusion performed according to local standard of care, defined as at least completing the initial diagnostic angiogram
• CTP performed with RAPID AI AngioFlowTM within 30 minutes of thrombectomy completion
• Modified thrombolysis in cerebral infarction (mTICI) 2b-3 revascularization following endovascular thrombectomy (EVT) (or after initial diagnostic angiogram)
• Presence of Tm > 6 lesion on post-EVT CTP of adequate quality for interpretation in the distribution of the symptomatic occlusion

Exclusion Criteria

• Current participation in another investigational drug or device study
• Known hypersensitivity or allergy to any ingredients of tenecteplase
• Active internal bleeding
• Known bleeding diathesis (e.g., Alzheimer's patients taking lecanemab)
• Systolic blood pressure > 185 mm Hg or diastolic blood pressure > 110 mm Hg after EVT, refractory to medical therapy
• Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; recent oral anticoagulant therapy with INR > 1.7
• Use of one of the new oral anticoagulants within the last 48 hours (dabigatran, rivaroxaban, apixaban, edoxaban)
• Treatment with a thrombolytic within the last 3 months prior to randomization
• Baseline platelet count < 100,000/mcL (results must be available prior to treatment)
• Baseline blood glucose > 400 mg/dL (22.20 mmol/L)
• Baseline blood glucose < 50 mg/dL; needs to be normalized prior to randomization
• Intracranial or intraspinal surgery or trauma within 2 months
• Intracranial malignant neoplasm, arteriovenous malformation, or unsecured aneurysm > 1 cm
• Other serious, advanced, or terminal illness (investigator's judgment) or life expectancy is less than 6 months
• History of acute ischemic stroke in the last 90 days
• History of hemorrhagic stroke
• Presumed septic embolus; suspicion of bacterial endocarditis
• Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the patient if an endovascular procedure was to be performed
• Pregnant
• Acute intracranial hemorrhage on pre-thrombectomy imaging or suspected acute intracranial hemorrhage after EVT
• Acute bilateral strokes on initial imaging
• Multiple acute intracranial occlusions (except ICA/MCA) on initial CTA or MRA
• Significant hemispheric mass effect or any amount of midline shift due to acute stroke
• Placement of cervical carotid or intracranial stent during thrombectomy procedure requiring dual antiplatelet therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intra-arterial Tenecteplase	Intra-arterial Tenecteplase	Following endovascular thrombectomy for large vessel occlusion stroke one-time dose of intra-arterial Tenecteplase (0.125 mg/kg, maximum dose 12.5 mg) will be delivered over 5-10 seconds by the treating neuro-interventionalist through a microcatheter positioned as close as possible to the residual thrombus or as distal as possible in the originating vessel, per the discretion of the neuro-interventionalist.
Intra-arterial Saline	Intra-arterial Saline	Following endovascular thrombectomy for large vessel occlusion stroke one-time dose of saline (0.9% NaCl solution) will be delivered over 5-10 seconds by the treating neuro-interventionalist through a microcatheter positioned as close as possible to the residual thrombus or as distal as possible in the originating vessel, per the discretion of the neuro-interventionalist.

Primary Outcome Measures

Name	Time	Method
30-Day Mortality Count	Day 30	Number of patients expired
Participants with Change in Symptomatic Intracranial Hemorrhage	Hour 36	Number of participants with symptomatic intracranial hemorrhage (parenchymal hematoma type 2, subarachnoid hemorrhage, and/or intraventricular hemorrhage) producing decline from the initial National Institutes of Health Stroke Scale (NIHSS) of ≥ 4 points.
Participants with Parenchymal Hematoma Type 1	24 Hours	Number of participants with parenchymal hematoma type 1
Participants with Parenchymal Hematoma Type 2	24 Hours	Number of participants with parenchymal hematoma type 2
90-Day Mortality Count	Day 90	Number of patients expired
Number of Grade 3 Adverse Events	Day 90	Total number of grade 3 adverse events

Trial Locations

Locations (1)

Atrium Health Neurosciences Institute; 🇺🇸 Charlotte, North Carolina, United States