NCT06949228

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P75+ for phase_2

Timeline
26mo left

Started Jul 2025

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Jul 2025May 2028

First Submitted

Initial submission to the registry

April 17, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 29, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

July 30, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2028

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

2.8 years

First QC Date

April 17, 2025

Last Update Submit

January 20, 2026

Conditions

Ischemic StrokeAcute Disease

Keywords

StrokeTNKThrombolytic

Outcome Measures

Primary Outcomes (2)

  • 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).

    90 days (+/- 30 days) post treatment.

  • 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.

    24 hours (+/-12 hours) post treatment.

Secondary Outcomes (8)

  • Ordinal Modified Rankin Scale (mRS)

    90 days (+/-30 days) post treatment.

  • Functional Independence

    90 days (+/- 30 days) post treatment.

  • Final Revascularization Grade

    Immediate post treatment.

  • Mortality rate at 90 days

    Mortality rate at 90-days (+/- 30 days) post treatment.

  • Mortality Rate at discharge

    Day 6 (+/-1 day) or Discharge post treatment.

  • +3 more secondary outcomes

Study Arms (2)

Randomized to Intra Arterial (IA) Tenecteplase (TNK)

EXPERIMENTAL

Patients will receive IA- TNK

Drug: tenecteplase

Randomized to best medical practice

NO INTERVENTION

Patients will receive best medical practice treatment

Interventions

tenecteplaseDRUG

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 Intra Arterial (IA) Tenecteplase (TNK)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Ability to obtain signed informed consent prior to randomization from LAR or Subject

You may not qualify if:

  • 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
  • Active anticoagulation treatment with novel oral anticoagulant (NOACs) taken within the last 48 hours, or INR \>1.7
  • Patients requiring active treatment with dual antiplatelet agents (e.g. proximal cervical carotid artery stenting)
  • Pregnant or lactating
  • Previous known allergy to TNK
  • Major surgery in past 30 days
  • Patient is on or requires dialysis
  • History of intracranial hemorrhage or serious head trauma at any time
  • Any condition in the opinion of the enrolling physician that would preclude the patient from participating
  • Pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluation
  • Severe, uncontrolled hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg) that is refractory to treatment
  • History of acute ischemic stroke in the last 60 days and/or has received previous treatment with a thrombolytic within the last 90 days
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ProMedica Toledo Hospital

Toledo, Ohio, 43606, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39772606RESULT

MeSH Terms

Conditions

Ischemic StrokeAcute DiseaseStroke

Interventions

Tenecteplase

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tissue Plasminogen ActivatorSerine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesPlasminogen ActivatorsBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and Proteins

Central Study Contacts

Syed Fazal Zaidi, MD

CONTACT

(419)- 291-8027Syed.Zaidi2@utoledo.edu

Tanya Siddiqui

CONTACT

4192913498

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2025

First Posted

April 29, 2025

Study Start

July 30, 2025

Primary Completion (Estimated)

May 30, 2028

Study Completion (Estimated)

May 30, 2028

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)