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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Tenecteplase, a clot-busting drug, to determine its effectiveness for stroke patients with a blocked blood vessel in the brain. Researchers aim to assess the safety and efficacy of this treatment when combined with a procedure that removes the blockage. Participants will receive either Tenecteplase or the current best medical care. Individuals who have recently experienced a stroke due to a blockage in certain major brain arteries and have already undergone a procedure to remove the blockage may be suitable for this trial. As a Phase 2, Phase 3 trial, this study measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking stroke treatment advancements.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking certain medications, like novel oral anticoagulants (NOACs) within 48 hours before the trial, and you cannot be on dual antiplatelet therapy. If you're on these medications, you may need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In a previous study, researchers examined the safety of using intra-arterial tenecteplase (IA-TNK) to treat strokes, focusing on symptomatic intracranial hemorrhage (sICH), which involves brain bleeding that can cause symptoms. The study found that the rate of sICH within 48 hours of treatment was not higher with IA-TNK compared to other treatments.

Researchers also assessed death rates within 90 days after treatment. The results showed that IA-TNK did not increase the number of deaths compared to other methods, suggesting that IA-TNK is generally safe for treating strokes in patients who have already undergone clot removal (thrombectomy).

These findings support the safety of IA-TNK, but individual results can vary. Patients should consult their healthcare provider to understand the risks and benefits for their specific situation. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for stroke?

Tenecteplase is unique because, unlike the standard clot-busting drugs used for strokes, it is delivered directly into the artery (intra-arterial), which could enhance its effectiveness and precision. This method might allow tenecteplase to better target and dissolve clots quickly, potentially reducing the time to see improvements in stroke symptoms. Researchers are excited about tenecteplase because it could offer a more targeted approach to treatment, possibly leading to better outcomes and fewer side effects compared to current options like intravenous alteplase.

What evidence suggests that Tenecteplase might be an effective treatment for acute ischemic stroke?

This trial will compare intra-arterial tenecteplase (IA-TNK) with the best medical practice for stroke treatment. Studies have shown that administering tenecteplase directly into the arteries can improve recovery from severe strokes following a procedure called mechanical thrombectomy. Research indicates that patients receiving this treatment are more likely to have excellent brain function 90 days later compared to those who do not. Additionally, this treatment does not appear to increase the risk of side effects. These findings suggest that tenecteplase could be a valuable addition to current stroke treatments, particularly for strokes caused by large blood vessel blockages. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.125.053256

Tenecteplase for Acute Ischemic Stroke at 4.5 to 24 Hours The efficacy outcomes comprised: (1) excellent functional outcome (mRS score, 0–1 at 90 days), (2) good functional outcome (mRS score, 0–2 at 90 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40616323/

Intra-arterial Tenecteplase for Acute Stroke After ... Intra-arterial tenecteplase after successful thrombectomy had a greater likelihood of excellent neurological outcome at 90 days without increasing the risk of ...

3. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2829205

Intra-Arterial Tenecteplase Following Endovascular ... This randomized clinical trial assesses the effect of adjunctive intra-arterial tenecteplase on freedom from disability at 90 days in ...

4. jnis.bmj.com jnis.bmj.com/content/early/2025/10/23/jnis-2025-024129

Occlusion site and outcomes in intra-arterial tenecteplase ... Intra-arterial (IA) tenecteplase shows potential for large vessel occlusion (LVO) stroke, but prior research did not stratify its efficacy/ ...

5. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2023.1155269/full

Intra-arterial tenecteplase is safe and may improve the first- ... This is the first study to report that intra-arterial TNK during the first pass of EVT seems safe and feasible in AIS-LVO patients.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41106193/

Efficacy and safety of adjunctive intra-arterial tenecteplase ... Our meta-analysis suggests that IA-TNK may offer a modest benefit in achieving excellent functional outcomes (mRS 0-1), particularly in ...

7. ahajournals.org ahajournals.org/doi/10.1161/SVIN.125.001847

Intra‐Arterial Thrombolysis After Successful Thrombectomy BackgroundThis study aims to conduct a systematic review and meta‐analysis of randomized controlled trials (RCTs) to assess the efficacy and ...

8. jwatch.org jwatch.org/na58989/2025/09/26/intra-arterial-tenecteplase-after-stroke-thrombectomy-more

Intra-Arterial Tenecteplase After Stroke Thrombectomy Safety endpoints included symptomatic intracranial hemorrhage (sICH) within 48 hours and mortality within 90 days. Key results included: The ...