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

NCT06781385 | Enrolling By Invitation Phase 2 DMC FDA Drug

• 2 other identifiers: IRB0012106640010317
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. Intravenous Tenecteplase is FDA-approved to treat patients with an ischemic stroke presenting within the 0-3-hour time window.

Conditions

Acute Ischemic Stroke

Keywords

brain hemorrhage; stroke; blood clot

Outcome Measures

Primary Outcomes (9)

• Participants with Change in Symptomatic Intracranial Hemorrhage

  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.

  Hour 36

• Participants with Parenchymal Hematoma Type 1

  Number of participants with parenchymal hematoma type 1

  24 Hours

• Participants with Parenchymal Hematoma Type 2

  Number of participants with parenchymal hematoma type 2

  24 Hours

• 30-Day Mortality Count

  Number of patients expired

  Day 30

• 90-Day Mortality Count

  Number of patients expired

  Day 90

• Number of Grade 3 Adverse Events

  Total number of grade 3 adverse events

  Hour 24

• Number of Grade 3 Adverse Events

  Total number of grade 3 adverse events

  Day 5

• Number of Grade 3 Adverse Events

  Total number of grade 3 adverse events

  Day 30

• Number of Grade 3 Adverse Events

  Total number of grade 3 adverse events

  Day 90

Other Outcomes (9)

• Proportion of subjects achieving early neurological improvement

  Hour 24

• Proportion of subjects achieving delayed neurological improvement

  Day 30, Day 90

• Ordinal Modified Rankin Scale score

  Day 90

Study Arms (2)

Intra-arterial Tenecteplase

EXPERIMENTAL

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.

Drug: Intra-arterial Tenecteplase

Intra-arterial Saline

PLACEBO COMPARATOR

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.

Drug: Intra-arterial Saline

Interventions

Intra-arterial Tenecteplase DRUG

One-time dose of intra-arterial tenecteplase post-thrombectomy

Intra-arterial Tenecteplase

Intra-arterial Saline DRUG

One-time dose of intra-arterial saline post-thrombectomy

Intra-arterial Saline

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Atrium Health Neurosciences Institute

Charlotte, North Carolina, 28207, United States

Location

MeSH Terms

Conditions

Ischemic Stroke; Intracranial Hemorrhages; Stroke; Thrombosis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis

Study Officials

• Rahul Karamchandani, MD

  Atrium Health Neurosciences Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 17, 2025
• Study Start: September 22, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)