Intra-Arterial Tenecteplase Following Endovascular Thrombectomy for Large Vessel Occlusion Stroke
Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Jan 13, 2025
Trial Information
Current as of July 22, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is exploring the safety and effectiveness of a drug called Tenecteplase when given directly into the arteries of patients who are undergoing a procedure to remove a blood clot caused by an acute ischemic stroke. While Tenecteplase is already approved for treating heart attacks, it is not yet approved for stroke treatment, and this study aims to see if it can be safely used in this new way.
To be eligible for the trial, participants need to be 65 years or older, have had a certain level of disability before the stroke, and show specific signs of a blockage in critical brain arteries on brain scans. They must also be able to give consent, either themselves or through a legally authorized representative. If chosen to participate, individuals will receive Tenecteplase during their treatment for the stroke, and doctors will monitor their response to see how well it works and if it is safe. This trial is not yet recruiting participants, so there will be more information available as it progresses.
Gender
ALL
Eligibility criteria
- 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
About Wake Forest University Health Sciences
Wake Forest University Health Sciences is a leading academic research institution dedicated to advancing healthcare through innovative clinical trials and translational research. With a strong emphasis on multidisciplinary collaboration, the organization leverages its extensive expertise in medical research, patient care, and education to develop and evaluate new therapies and interventions. Committed to improving patient outcomes and public health, Wake Forest University Health Sciences fosters a dynamic environment for scientific inquiry, engaging in a wide range of clinical studies that address pressing health challenges. Through its rigorous methodologies and ethical standards, the institution aims to contribute significantly to the medical field and enhance the quality of life for diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Charlotte, North Carolina, United States
Patients applied
Trial Officials
Rahul Karamchandani, MD
Principal Investigator
Atrium Health Neurosciences Institute
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported