ALLY II Trial: Tenecteplase for Ischemic Stroke After Thrombectomy
This study, called the ALLY II Trial, is looking at whether adding a medicine called tenecteplase directly into an artery (intra-arterial) can help patients who have had a severe type of stroke (ischemic stroke) and have already undergone a procedure to remove a clot (mechanical thrombectomy). Researchers want to see if tenecteplase is safe and effective in improving recovery for patients whose blood flow was largely restored after the initial procedure. You might be able to join if you are 18-85 years old, had a specific type of stroke within 24 hours, and meet certain brain scan criteria after your thrombectomy. The study will measure your recovery at 90 days and check for any safety concerns within 24 hours.
- Study design
- This is an interventional study with a planned enrollment of 132 participants. Patients will be randomly assigned to receive either tenecteplase or a control.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your recovery will be measured at 90 days after treatment, and safety will be checked at 24 hours after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy (ALLY) II Trial
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Primary Efficacy Endpoint- Modified Rankin Scale (mRS)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 Worsening24 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.