Recruiting
Phase 2
Phase 3

IA Tenecteplase

Sponsor:

ProMedica Health System

Code:

NCT06949228

Conditions

Ischemic Stroke

Acute Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

tenecteplase

Study Details

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 ID

NCT06949228

Start date

Jul 30, 2025

Status verified date

Jan, 2026

Completion date

May 30, 2028

Anticipated

Primary completion date

May 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

132 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Randomized to Intra Arterial (IA) Tenecteplase (TNK)

Patients will receive IA- TNK

no intervention: Randomized to best medical practice

Patients will receive best medical practice treatment

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.

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Tanya Siddiqui

4192913498

Locations

ProMedica Toledo Hospital

Recruiting

Toledo, Ohio, United States, 43606

More Information

Sponsor

ProMedica Health System

Last update posted

Jan 21, 2026

Last verified

Jan, 2026

Keywords

  • Stroke
  • TNK
  • Thrombolytic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by ProMedica Health System on 2026-01-21.