Using Tenecteplase after Mechanical Thrombectomy for Stroke

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

This study is testing if adding a drug called Tenecteplase after a procedure to remove a blood clot can help people who have had a stroke feel better and recover more effectively.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 132 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: ProMedica Health System (Academic / other)
• Locations: 1 site (Toledo, Ohio)
• Trial ID: NCT06949228 on ClinicalTrials.gov

What this trial studies

This trial evaluates the safety and effectiveness of intra-arterial Tenecteplase as an additional treatment for patients experiencing acute ischemic stroke due to large vessel occlusions. Participants must have undergone mechanical thrombectomy and achieved a specific level of blood flow restoration. The study focuses on patients with anterior circulation strokes and aims to determine if this adjunctive therapy can improve outcomes following thrombectomy. The trial is conducted at ProMedica Toledo Hospital in Ohio.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-85 who have experienced an anterior circulation ischemic stroke and have undergone mechanical thrombectomy.

Not a fit: Patients with significant premorbid disability, active hemorrhagic conditions, or those on certain anticoagulant therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients suffering from acute ischemic strokes.

How similar studies have performed: Other studies have shown promise with similar thrombolytic approaches, suggesting potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

1. Age 18-85
2. 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
3. Alberta Stroke Program Early CT Score (ASPECTS) Score ≥6 on baseline Non-contrast Head CT (NCCT)
4. Post-mechanical thrombectomy with ≤5 device passes and mTICI grade 2b or higher.
5. Ability to obtain signed informed consent prior to randomization from LAR or Subject

Exclusion Criteria:

1. Premorbid modified Rankin scale (mRS) score \>1
2. Imaging evidence of hemorrhage or mass effect at baseline
3. Platelet count \<100,000
4. Active hemorrhagic diathesis, or known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
5. Active anticoagulation treatment with novel oral anticoagulant (NOACs) taken within the last 48 hours, or INR \>1.7
6. Patients requiring active treatment with dual antiplatelet agents (e.g. proximal cervical carotid artery stenting)
7. Pregnant or lactating
8. Previous known allergy to TNK
9. Major surgery in past 30 days
10. Patient is on or requires dialysis
11. History of intracranial hemorrhage or serious head trauma at any time
12. Any condition in the opinion of the enrolling physician that would preclude the patient from participating
13. Pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluation
14. Severe, uncontrolled hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg) that is refractory to treatment
15. History of acute ischemic stroke in the last 60 days and/or has received previous treatment with a thrombolytic within the last 90 days
16. Presumed septic embolus; suspicion of bacterial endocarditis
17. Suspicion of aortic dissection
18. Intracranial neoplasm
19. Any terminal medical condition with life expectancy less than 6 months
20. Concurrent enrollment in another trial that could confound the results of this study
21. Patient is unlikely to return for 90-day follow-up.
22. Intravenous tissue plasminogen activator (tPA) administered concurrently with Intra-arterial TNK

Where this trial is running

Toledo, Ohio

• ProMedica Toledo Hospital — Toledo, Ohio, United States (Recruiting)

Study contacts

• Study coordinator: Syed Fazal Zaidi, MD

Conditions Ischemic Stroke; Acute Disease; Stroke; TNK; Thrombolytic