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

NCT ID: NCT06949228

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-30
• Study Completion Date: 2028-05-30

Brief Summary

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.

Conditions

Ischemic Stroke; Acute Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Randomized to Intra Arterial (IA) Tenecteplase (TNK)

Patients will receive IA- TNK

Group Type: EXPERIMENTAL

tenecteplase

Intervention Type: DRUG

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.

Randomized to best medical practice

Patients will receive best medical practice treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ProMedica Health System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ProMedica Toledo Hospital

Toledo, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Syed Fazal Zaidi, MD

Role: CONTACT

Syed.Zaidi2@utoledo.edu

(419)- 291-8027

Tanya Siddiqui

Role: CONTACT

4192913498

References

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.

Reference Type: BACKGROUND

PMID: 39772606 (View on PubMed)

Other Identifiers

ALLY II

Identifier Type: -

Identifier Source: org_study_id