Basilar Artery OcclusionPhase 2NCT05580822
Additive Effects of Intra-arterial Tenecteplase for Successful Thrombectomy Due to Acute Basilar Artery Occlusion
A Phase 2 study testing Tenecteplase for Injection and Saline in people with Basilar Artery Occlusion and Thrombectomy, run by First Hospital of China Medical University.
Trial summary
Recent studies revealed the safety and effectiveness of EVT in patients with acute occlusion at basilar artery, showing that up to 46% of patients receiving EVT had favorable functional outcome at 3 months (ATTENTION and BAOCHE trials, ESOC). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Basilar Artery Occlusion, Thrombectomy, Tenecteplase
- What is being tested?
- Tenecteplase for Injection and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 520 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 80 yro；
- Acute symptomatic basilar artery occlusion identified by neuroimaging modalities (CTA/MRA/DSA)；
- NIHSS ≥ 6 before thrombectomy；
- Time from symptom onset (or last seen normal) to arterial TNK/placebo is less than 24 hours；
- pc-ASPECTS ≥ 6 and Pons-midbrain-index ≤ 2
- Successful recanalization（eTICI 2b-3）at the end of procedure（The maximum will be six passes or six aspirations for the patient）；Patients with an eTICI score 2b/3 on the diagnostic cerebral angiography before the onset of MT are also eligible for the study.
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- Exclusion of parenchymal hemorrhagic transformation (DynaCT/XpertCT) before intra-arterial agent administration；
- Pre-morbid mRS ≤ 1；
- Patient or legal proxy is able to understand and willing to provide written inform and consent.
Who cannot join
- Patient received thrombolysis prior to EVT
- NIHSS score on admission >25
- Contraindication to IA TNK as per local national guidelines (except time to therapy)
- Use of stents during the endovascular procedure requiring dual antiplatelet therapy during the first 24h
- Female who is pregnant or lactating or has a positive pregnancy test at time of admission
- Current participation in another investigation drug or device treatment study (except observational study)
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- Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
- Known coagulopathy, INR >1.7 or use of novel anticoagulants < 48h from symptom onset
- Platelets <100,000
- Renal Failure as defined by a serum creatinine >3.0 mg/dl (or 265.2 μmol/l) or glomerular Filtration Rate [GFR] <30.
- Subject who requires hemodialysis or peritoneal dialysis, or who have a contraindication to an angiogram for whatever reason
- Any hemorrhage on CT/MRI
- Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal
- Suspicion of aortic dissection
- Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol
- History of life threatening allergy (more than rash) to TNK or contrast medium
- SBP >185 mmHg or DBP >110 mmHg refractory to treatment
- Serious, advanced, terminal illness with anticipated life expectancy <6 months
- Pre-existing neurological or psychiatric disease that would confound evaluation
- Presumed vasculitis or septic embolization
- Unlikely to be available for 90-day follow-up (e.g. no fixed home address, visitor from overseas)
- Other conditions at investigators' discretion which are not appropriate for participation.
About this study
Official title: Additive Effects of Intra-arterial Tenecteplase for Successful Thrombectomy Due to Acute Basilar Artery Occlusion (ARTERIAL TNK BAO)：a Prospective, Randomized, Open-label, Blinded Endpoint, Multicenter, Phase 2 Study
Recent studies revealed the safety and effectiveness of EVT in patients with acute occlusion at basilar artery, showing that up to 46% of patients receiving EVT had favorable functional outcome at 3 months (ATTENTION and BAOCHE trials, ESOC). Although the rate of successful recanalization can be as high as 90% , a large number of these patients remains to be functionally independent while recovery. In addition, a number of recent studies indicated the functional outcome of patients with successful recanalization of TICI 2b was not as good as those with TICI 3 grade. Therefore, restoring reperfusion of distal vessels and territorial microcirculation may be pivotal to further improvement of neurological outcomes for AIS patients receiving EVT. Correspondingly, a very recent Spanish multicenter randomized trial showed the effect of further functional improvement of post-EVT intra-arterial alteplase for successful mechanical thrombectomy in anterior circulation More importantly, head-to-head comparison between TNK and tPA showed the former has a significantly higher chance of reperfusion, indicating that TNK may be a potentially better candidate for post-EVT bridging.
Based on the above findings, we hypothesize in the present study that, adjunct intra-arterial tenecteplase after successful thrombectomy could enhance the functional improvement in patients with acute basilar artery occlusion.
- Conditions
- Basilar Artery Occlusion, Thrombectomy, Tenecteplase
- Being tested
- Tenecteplase for Injection, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenecteplase for InjectionDrug
intra-arterial TNK infusing after successful thrombectomy for patient with acute basilar artery occlusion via support/access catheter
SalineDrug
intra-arterial saline infusing after successful thrombectomy for patient with acute basilar artery occlusion via support/access catheter
| Study group | Role | What they receive |
|---|---|---|
| intra-arterial TNK infusion (0.4mg/min) via support/access catheter, over 15 minutes | Experimental | Not described Receives: Drug: Tenecteplase for Injection |
| intra-arterial TNK infusion (0.25mg/min) via support/access catheter, over 15 minutes | Experimental | Not described Receives: Drug: Tenecteplase for Injection |
| intra-arterial placebo infusion via support/access catheter, over 15 minutes | Placebo comparator | Not described Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
mRS 0-3
The proportion of patients with a modified Rankin Scale 0 to 3 at 90 days
Measured: 90 days
symptomatic ICH
The proportion of symptomatic ICH within 24 hours after allocated intervention
Measured: 24 hours
Secondary outcomes (6)
mRS 0-1
The proportion of patients with a mRS 0 to 1 at 90 days
Measured: 90 days
mRS 0-2
The proportion of patients with a mRS 0 to 2 at 90 days
Measured: 90 days
mRS shift
The proportion of patients with a mRS shift at 90 days
Measured: 90 days
early neurological improvement
The proportion of patients with early neurological improvement (NIHSS reduction > 4) at 48 hours
Measured: 48 hours
PH1 and PH2 sICH
The proportion of subtypes (PH1 and PH2) of sICH within 24 hours after allocated intervention
Measured: 24 hours
mortality
The proportion of mortality at 90 days
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start1 Jan 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basilar Artery OcclusionStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Hospital of China Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chuansheng Zhao, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580822
- Sponsor's protocol ID
- ARTERIAL-TNK-BAO-202201
- Status last verified
- Oct 2022
- First submitted
- 12 Oct 2022
- Last updated
- 14 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additive Effects of Intra-arterial Tenecteplase for Successful Thrombectomy Due to Acute Basilar Artery Occlusion (ARTERIAL TNK BAO)：a Prospective, Randomized, Open-label, Blinded Endpoint, Multicenter, Phase 2 Study
- ClinicalTrials.gov ID
- NCT05580822
- Acronym / sponsor ID
- ARTERIAL-TNK-BAO-202201
- Conditions
- Basilar Artery Occlusion, Thrombectomy, Tenecteplase
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Oct 2022 (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.
Recent studies revealed the safety and effectiveness of EVT in patients with acute occlusion at basilar artery, showing that up to 46% of patients receiving EVT had favorable functional outcome at 3 months (ATTENTION and BAOCHE trials, ESOC). Although the rate of successful recanalization can be as high as 90% , a large number of these patients remains to be functionally independent while recovery. In addition, a number of recent studies indicated the functional outcome of patients with successful recanalization of TICI 2b was not as good as those with TICI 3 grade. Therefore, restoring reperfusion of distal vessels and territorial microcirculation may be pivotal to further improvement of neurological outcomes for AIS patients receiving EVT. Correspondingly, a very recent Spanish multicenter randomized trial showed the effect of further functional improvement of post-EVT intra-arterial alteplase for successful mechanical thrombectomy in anterior circulation More importantly, head-to-head comparison between TNK and tPA showed the former has a significantly higher chance of reperfusion, indicating that TNK may be a potentially better candidate for post-EVT bridging.
Based on the above findings, we hypothesize in the present study that, adjunct intra-arterial tenecteplase after successful thrombectomy could enhance the functional improvement in patients with acute basilar artery occlusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| intra-arterial TNK infusion (0.4mg/min) via support/access catheter, over 15 minutes | Experimental | Drug: Tenecteplase for Injection |
| intra-arterial TNK infusion (0.25mg/min) via support/access catheter, over 15 minutes | Experimental | Drug: Tenecteplase for Injection |
| intra-arterial placebo infusion via support/access catheter, over 15 minutes | Placebo comparator | Drug: Saline |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 - 80 yro；
- Acute symptomatic basilar artery occlusion identified by neuroimaging modalities (CTA/MRA/DSA)；
- NIHSS ≥ 6 before thrombectomy；
- Time from symptom onset (or last seen normal) to arterial TNK/placebo is less than 24 hours；
- pc-ASPECTS ≥ 6 and Pons-midbrain-index ≤ 2
Key exclusion criteria (22 listed)
- Patient received thrombolysis prior to EVT
- NIHSS score on admission >25
- Contraindication to IA TNK as per local national guidelines (except time to therapy)
- Use of stents during the endovascular procedure requiring dual antiplatelet therapy during the first 24h
- Female who is pregnant or lactating or has a positive pregnancy test at time of admission
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 |
|---|---|---|
| Tenecteplase for Injectionintra-arterial TNK infusing after successful thrombectomy for patient with acute basilar artery occlusion via support/access catheter | Drug | intra-arterial TNK infusion (0.25mg/min) via support/access catheter, over 15 minutes, intra-arterial TNK infusion (0.4mg/min) via support/access catheter, over 15 minutes |
| Salineintra-arterial saline infusing after successful thrombectomy for patient with acute basilar artery occlusion via support/access catheter | Drug | intra-arterial placebo infusion via support/access catheter, over 15 minutes |
Primary outcome
mRS 0-3
Time frame: 90 days
The proportion of patients with a modified Rankin Scale 0 to 3 at 90 days
symptomatic ICH
Time frame: 24 hours
The proportion of symptomatic ICH within 24 hours after allocated intervention
6 secondary outcomes
mRS 0-1
Time frame: 90 days
mRS 0-2
Time frame: 90 days
mRS shift
Time frame: 90 days
early neurological improvement
Time frame: 48 hours
PH1 and PH2 sICH
Time frame: 24 hours
mortality
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tenecteplase for Injection and Saline in people with Basilar Artery Occlusion and Thrombectomy, run by First Hospital of China Medical University.
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 9 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: status not confirmed, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mRS 0-3 (time frame: 90 days). 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?
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 14 Oct 2022; AzTrials last refreshed its copy on 7 Nov 2026.