Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy (ALLY) II Trial
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorProMedica Health System
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
tenecteplase
DrugPatients 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.
Treatment groups
132 Participants
are divided into 2 treatment groupsGroup A: Randomized to Intra Arterial (IA) Tenecteplase (TNK)Experimental treatment 1 intervention
Group B: Randomized to best medical practiceNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Primary Efficacy Endpoint- Modified Rankin Scale (mRS)
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).
Time frame
90 days (+/- 30 days) post treatment.2
Primary Safety Endpoint- Incidence of Intracranial hemorrhage and Neurologic Worsening
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.
Time frame
24 hours (+/-12 hours) post treatment.Secondary outcomes
1
Ordinal Modified Rankin Scale (mRS)
Ordinal mRS at 90 day. 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).
Time frame
90 days (+/-30 days) post treatment.2
Functional Independence
Proportion of patients with functional independence, defined as a mRS of 0-2 at 90 days.
Time frame
90 days (+/- 30 days) post treatment.3
Final Revascularization Grade
Final revascularization grade at end of IA treatment among those with less than mTICI 3 prior to IA-TNK administration.
Time frame
Immediate post treatment.4
Mortality rate at 90 days
Mortality rate at 90-days
Time frame
Mortality rate at 90-days (+/- 30 days) post treatment.Sponsors and contacts
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Source ClinicalTrials.gov