NCT06949228 · ProMedica Health System
Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy (ALLY) II Trial
(ALLY II TNK)
What this study is about
The study objective is to evaluate the safety and effectiveness 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.
View original scientific description
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.
Interventions
DRUG
tenecteplase
Patients treated with standard of care mechanical thrombectomy (MT) that achieved mTICI 2b or higher revascularization. Patients will be randomized into one of two arms: IA TNK or control.
Primary outcome measures
Primary Efficacy Endpoint- Modified Rankin Scale (mRS)
Time frame: 90 days (+/- 30 days) post treatment.
Proportion of patients with Modified Rankin Scale (mRS) 0-1 at 90-days. The mRS is the standard tool to assess neurological outcome in trials with acute severe brain disease. The scale runs from 0-6, running from perfect health without symptoms (= 0) to death (= 6).
Primary Safety Endpoint- Incidence of Intracranial hemorrhage and Neurologic Worsening
Time frame: 24 hours (+/-12 hours) post treatment.
Incidence of any intracranial hemorrhage and neurologic worsening of at least 4 points on the National Institute of Health Stroke Scale (NIHSS) associated with a Parenchymal hematoma, Type 2 (PH2) brain hemorrhage, according to the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST) criteria, within 24 (±12) hours from randomization.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
Where
- Toledo, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 21, 2026 · Source of record for eligibility and locations