Clinical trial 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?
An investigational drug being studied as a potential treatment for acute ischemic stroke from large vessel occlusion. is designed to dissolve blood clots by activating plasminogen into plasmin.
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
- The study wants to see if giving tenecteplase directly into the artery after a clot is removed helps blood flow in tiny vessels and reduces brain damage.
- Who it's for
- It is for adults who have had a large‑vessel stroke in the front part of the brain and have just had a clot‑removal procedure.
- What's involved
- Participants receive a single weight‑based dose of tenecteplase through a catheter after the clot is cleared. Blood flow is measured before and after the drug, and brain scans are done at 24 and 72 hours. Stroke severity is checked soon after and again at 90 days.
- Time commitment
- The study lasts about 90 days, with visits for imaging and stroke assessments shortly after treatment and a final follow‑up at 90 days.
- 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
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.