Tenecteplase for Stroke

(ALLY II TNK Trial)

Overseen By Syed Fazal Zaidi, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: ProMedica Health System

Must not be taking: NOACs, Dual antiplatelets, tPA

Disqualifiers: Hemorrhage, Dialysis, Hypertension, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate post procedure

132 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults aged 18-85 who've had a stroke with specific large vessel blockages in the brain and have already undergone mechanical thrombectomy. They should have started treatment within 24 hours of symptom onset, have a certain level of brain health on CT scans, and be able to give consent.

Inclusion Criteria

My initial brain scan score is 6 or higher.

I had a stroke with a blocked artery in my brain and received clot removal treatment within 24 hours.

I had a clot removal with a device used ≤5 times and good blood flow restoration.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive Intra Arterial Tenecteplase (IA-TNK) or best medical practice following mechanical thrombectomy

Immediate post procedure

Initial Follow-up

Participants are monitored for intracranial hemorrhage and neurologic worsening

24 hours (+/- 12 hours)

Extended Follow-up

Participants are assessed for neurological outcomes and mortality at 90 days

90 days (+/- 30 days)

Treatment Details

Interventions

• Tenecteplase

Trial Overview The ALLEY II Trial is testing if adding Tenecteplase directly into the artery after mechanical clot removal (thrombectomy) can improve outcomes for acute stroke patients with major blood vessel blockage in the brain.

Participant Groups

Group I: Randomized to Intra Arterial (IA) Tenecteplase (TNK) Experimental Treatment 1 Intervention

Patients will receive IA- TNK

Group II: Randomized to best medical practice Active Control 1 Intervention

Patients will receive best medical practice treatment

Who Is Running the Clinical Trial?

ProMedica Health System

Lead Sponsor

Trials

14

Recruited

760+