Ischemic StrokePhase 2/3ALLY II TNKNCT06949228
Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy (ALLY) II Trial
A Phase 2/3 study testing tenecteplase in people with Ischemic Stroke and Acute Disease, run by ProMedica Health System at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic Stroke, Acute Disease
- What is being tested?
- tenecteplase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2025to 30 May 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 22Show fewer
- 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
- Presumed septic embolus; suspicion of bacterial endocarditis
- Suspicion of aortic dissection
- Intracranial neoplasm
- Any terminal medical condition with life expectancy less than 6 months
- Concurrent enrollment in another trial that could confound the results of this study
- Patient is unlikely to return for 90-day follow-up.
- Intravenous tissue plasminogen activator (tPA) administered concurrently with Intra-arterial TNK
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tanya Siddiqui contact
United States1 site, 1 recruiting
- Recruiting
ProMedica Toledo Hospital
Toledo, Ohio, 43606
About this study
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
- Being tested
- tenecteplase
- Keywords
- Stroke, TNK, Thrombolytic
- Medical subject headings
- Ischemic Stroke, Acute Disease, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Randomized to Intra Arterial (IA) Tenecteplase (TNK) | Experimental | Patients will receive IA- TNK Receives: Drug: tenecteplase |
| Randomized to best medical practice | No intervention | Patients will receive best medical practice treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 24 hours (+/-12 hours) post treatment.
Secondary outcomes (8)
Ordinal Modified Rankin Scale (mRS)
Ordinal mRS at 90 day. 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).
Measured: 90 days (+/-30 days) post treatment.
Functional Independence
Proportion of patients with functional independence, defined as a mRS of 0-2 at 90 days.
Measured: 90 days (+/- 30 days) post treatment.
Final Revascularization Grade
Final revascularization grade at end of IA treatment among those with less than mTICI 3 prior to IA-TNK administration.
Measured: Immediate post treatment.
Mortality rate at 90 days
Mortality rate at 90-days
Measured: Mortality rate at 90-days (+/- 30 days) post treatment.
Mortality Rate at discharge
Mortality rate at discharge.
Measured: Day 6 (+/-1 day) or Discharge post treatment.
Infarct Volume Post Procedure
Infarct volume on post-procedure follow-up scans performed at 24 ± 12 hours following mechanical thrombectomy.
Measured: 24 hours (+/- 12 hours) post treatment.
Asymptomatic Intracranial hemorrhage
Incidence of any asymptomatic intracranial hemorrhage
Measured: 24 hours (+/- 12 hours) post treatment.
Mean Number of Boluses
Mean number of boluses to achieve improvement in reperfusion to mTICI 2c and mTICI 3 among those without mTICI3 prior to IA-TNK administration.
Measured: Immediate post procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start30 Jul 2025
- Primary completion30 May 2028 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ProMedica Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06949228
- Sponsor's protocol ID
- ALLY II
- Acronym
- ALLY II TNK
- Status last verified
- Jan 2026
- First submitted
- 17 Apr 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39772606
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy (ALLY) II Trial
- ClinicalTrials.gov ID
- NCT06949228
- Acronym / sponsor ID
- ALLY II TNK / ALLY II
- Conditions
- Ischemic Stroke, Acute Disease
- Keywords
- Stroke, TNK, Thrombolytic
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- ProMedica Health SystemUniversity, hospital or other
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Randomized to Intra Arterial (IA) Tenecteplase (TNK) | Experimental | Drug: tenecteplasePatients will receive IA- TNK |
| Randomized to best medical practice | No intervention | –Patients will receive best medical practice treatment |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tenecteplasePatients 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. | Drug | Randomized to Intra Arterial (IA) Tenecteplase (TNK) |
Primary outcome
Primary Efficacy Endpoint- Modified Rankin Scale (mRS)
Time frame: 90 days (+/- 30 days) post treatment.
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).
Primary Safety Endpoint- Incidence of Intracranial hemorrhage and Neurologic Worsening
Time frame: 24 hours (+/-12 hours) post treatment.
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.
8 secondary outcomes
Ordinal Modified Rankin Scale (mRS)
Time frame: 90 days (+/-30 days) post treatment.
Functional Independence
Time frame: 90 days (+/- 30 days) post treatment.
Final Revascularization Grade
Time frame: Immediate post treatment.
Mortality rate at 90 days
Time frame: Mortality rate at 90-days (+/- 30 days) post treatment.
Mortality Rate at discharge
Time frame: Day 6 (+/-1 day) or Discharge post treatment.
Infarct Volume Post Procedure
Time frame: 24 hours (+/- 12 hours) post treatment.
Asymptomatic Intracranial hemorrhage
Time frame: 24 hours (+/- 12 hours) post treatment.
Mean Number of Boluses
Time frame: Immediate post procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Results publication: PubMed 39772606Zaidi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tanya Siddiqui contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing tenecteplase in people with Ischemic Stroke and Acute Disease, run by ProMedica Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Syed Fazal Zaidi, MD ((419)- 291-8027, Syed.Zaidi2@utoledo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Endpoint- Modified Rankin Scale (mRS) (time frame: 90 days (+/- 30 days) post treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06949228, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.