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New treatment option for Ischemic Stroke
Official title Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy (ALLY) II Trial
ClinicalTrials.gov ID: NCT06949228
What this study is testing
What is tenecteplase?
tenecteplase is an investigational medicine, being studied as a potential treatment for ischemic stroke.
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 objective is to evaluate the safety and efficacy of Intra arterial (IA) Tenecteplase (TNK) as an adjunctive therapy in acute ischemic stroke (AIS) patients with large vessel occlusions (LVO) in the anterior circulation of Internal Carotid Artery (ICA), Middle Cerebral Arteries (M1 and M2) who achieve a reperfusion grade of Modified Treatment in Cerebral Ischemia Scale (mTICI) 2b or higher post-mechanical thrombectomy using Food and Drug Administration (FDA) approved devices.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Age 18-85
- Anterior circulation ischemic stroke symptoms with confirmed occlusion (ICA, M1, or M2) on angiogram and mechanical thrombectomy initiated within 24...
- Alberta Stroke Program Early CT Score (ASPECTS) Score ≥6 on baseline Non-contrast Head CT (NCCT)
- Post-mechanical thrombectomy with ≤5 device passes and mTICI grade 2b or higher.
- Ability to obtain signed informed consent prior to randomization from LAR or Subject
You likely can't join if
- Premorbid modified Rankin scale (mRS) score \>1
- Imaging evidence of hemorrhage or mass effect at baseline
- Platelet count \<100,000
- Active hemorrhagic diathesis, or known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
- Active anticoagulation treatment with novel oral anticoagulant (NOACs) taken within the last 48 hours, or INR \>1.7
- Patients requiring active treatment with dual antiplatelet agents (e.g. proximal cervical carotid artery stenting)
See the full eligibility criteria
- Age 18-85
- Anterior circulation ischemic stroke symptoms with confirmed occlusion (ICA, M1, or M2) on angiogram and mechanical thrombectomy initiated within 24 hours since last known well
- Alberta Stroke Program Early CT Score (ASPECTS) Score ≥6 on baseline Non-contrast Head CT (NCCT)
- Post-mechanical thrombectomy with ≤5 device passes and mTICI grade 2b or higher.
- Ability to obtain signed informed consent prior to randomization from LAR or Subject
- Premorbid modified Rankin scale (mRS) score \>1
- Imaging evidence of hemorrhage or mass effect at baseline
- Platelet count \<100,000
- Active hemorrhagic diathesis, or known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
- Active anticoagulation treatment with novel oral anticoagulant (NOACs) taken within the last 48 hours, or INR \>1.7
- Patients requiring active treatment with dual antiplatelet agents (e.g. proximal cervical carotid artery stenting)
- Pregnant or lactating
- Previous known allergy to TNK
- Major surgery in past 30 days
- Patient is on or requires dialysis
- History of intracranial hemorrhage or serious head trauma at any time
- Any condition in the opinion of the enrolling physician that would preclude the patient from participating
- Pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluation
- Severe, uncontrolled hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg) that is refractory to treatment
- History of acute ischemic stroke in the last 60 days and/or has received previous treatment with a thrombolytic within the last 90 days
- Presumed septic embolus; suspicion of bacterial endocarditis
- Suspicion of aortic dissection
- Intracranial neoplasm
- Any terminal medical condition with life expectancy less than 6 months
- Concurrent enrollment in another trial that could confound the results of this study
- Patient is unlikely to return for 90-day follow-up.
- Intravenous tissue plasminogen activator (tPA) administered concurrently with Intra-arterial TNK
The study team makes the final eligibility decision.
Where it's taking place
- Toledo, Ohio, 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 to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toledo, Ohio, 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.