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Recruiting NCT06949228

Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy (ALLY) II Trial

Phase II / Phase III Interventional Ischemic Stroke Acute Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: tenecteplase.
Who it may be relevant to
Registry conditions: Ischemic Stroke, Acute Disease. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.]
  • Primary Safety Endpoint- Incidence of Intracranial hemorrhage and Neurologic Worsening [Time frame: 24 hours (+/-12 hours) post treatment.]
Secondary outcome measures (8)
  • Ordinal Modified Rankin Scale (mRS) [Time frame: 90 days (+/-30 days) post treatment.]
  • Functional Independence [Time frame: 90 days (+/- 30 days) post treatment.]
  • Final Revascularization Grade [Time frame: Immediate post treatment.]
  • Mortality rate at 90 days [Time frame: Mortality rate at 90-days (+/- 30 days) post treatment.]
  • Mortality Rate at discharge [Time frame: Day 6 (+/-1 day) or Discharge post treatment.]
  • Infarct Volume Post Procedure [Time frame: 24 hours (+/- 12 hours) post treatment.]
  • Asymptomatic Intracranial hemorrhage [Time frame: 24 hours (+/- 12 hours) post treatment.]
  • Mean Number of Boluses [Time frame: Immediate post procedure.]

Eligibility criteria

Inclusion 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • ProMedica Toledo Hospital — Toledo

Publications

  • Zaidi SF, Castonguay AC, Zaidat OO, Jadhav AP, Sheth SA, Haussen DC, Nguyen TN, Burgess RE, Alhajala HS, Gharaibeh K, Salahuddin H, Rao R, Oliver MJ, Jumaa MA. Safety of Adjunctive Intraarterial Tenecteplase Following Mechanical Thrombectomy: The ALLY Pilot Trial. Stroke. 2025 Feb;56(2):355-361. doi: 10.1161/STROKEAHA.124.048846. Epub 2025 Jan 8. PMID 39772606

Identifiers

NCT: NCT06949228 · ALLY II

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗