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New treatment option for Acute Ischemic Stroke From Large Vessel Occlusion
Official title Intra-Arterial Tenecteplase to Improve the Microvascular Hemodynamics After Mechanical Thrombectomy
ClinicalTrials.gov ID: NCT06904911
What this study is testing
What is intra-arterial tenecteplase administration?
intra-arterial tenecteplase administration is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute ischemic stroke from large vessel occlusion.
Also referred to as intra-arterial thrombolysis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a prospective, single-arm, open-label study to evaluate the efficacy of intra-arterial tenecteplase in improving microvascular reperfusion following successful large vessel recanalization. Acute ischemic stroke patients with large anterior circulation large vessel occlusion will receive a single weight-based dose of intra-arterial tenecteplase after achieving successful large vessel recanalization (defined as TICI ≥ 2b) via standard of care mechanical thrombectomy.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient/legally authorized representative has signed the Informed Consent Form
- At least 18 years of age
- Ability to comply with the study protocol, in the investigator's judgment
- Acute ischemic stroke attributed to anterior circulation large vessel occlusion (of the internal carotid artery or first segment of the middle...
- NIHSS ≥ 6 at the initiation of endovascular therapy (arterial puncture)
You likely can't join 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 (Alzheimer's patients taking lecanemab)
- 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)
See the full eligibility criteria
- Patient/legally authorized representative has signed the Informed Consent Form
- At least 18 years of age
- Ability to comply with the study protocol, in the investigator's judgment
- Acute ischemic stroke attributed to anterior circulation large vessel occlusion (of the internal carotid artery or first segment of the middle cerebral artery based on CTA, MRA, or catheter angiogram) being treated with...
- NIHSS ≥ 6 at the initiation of endovascular therapy (arterial puncture)
- Time from stroke onset to IA-TNK administration \< 24 hours. Stroke onset is defined as the time the patient was last known to be at their neurologic baseline
- ASPECTS ≥ 6 on pre-MT CT imaging
- If treated \> 6 hours from stroke onset, CTP imaging must demonstrates favorable mismatch profile (based on RAPID processing: infarct core \<70 mL, mismatch ratio ≥ 1.8 and mismatch volume ≥ 15 mL)
- Qualifying neuroimaging (CT and CTP, if applicable) must be obtained \<120 minutes prior to arterial puncture.
- Current participation in another investigational drug or device study
- Known hypersensitivity or allergy to any ingredients of tenecteplase
- Active internal bleeding
- Known bleeding diathesis (Alzheimer's patients taking lecanemab)
- 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, inclusive of intravenous thrombolysis during the index stroke.
- Baseline platelet count \< 100,000/microliter (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
- 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
- Systolic BP \>185 mmHg or diastolic BP \>110 mmHg, refractory to treatment
- Suspicion of aortic dissection
- Known allergy to iodine or iodinated contrast
- Subject who requires hemodialysis or peritoneal dialysis, or who have a contraindication to an angiogram
- Renal failure as defined by a serum creatinine \> 3.0 mg/dl or GFR \< 30
- Known intracranial neoplasm
- GI bleeding within the past 21 days
- Pre-existing medical or neurological disease that will confound the neurological or functional evaluations
- Premorbid (prior to the index stroke) modified Rankin Scale (mRS) score ≥ 3 Additional neuroimaging exclusion criteria:
- ASPECTS \<6 on pre-MT CT imaging
- Acute intracranial hemorrhage or contrast extravasation on CT before or immediately after MT (prior to study drug administration)
- Significant mass effect with midline shift on non-contrast CT before or immediately after MT
- Cervical or intracranial stent placement during endovascular therapy
- Acute symptomatic arterial occlusions in more than one vascular territory confirmed on CTA, MRA, or catheter angiography
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.