AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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
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.
Show all 9Show fewer
  • 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)
Show all 22Show fewer
  • 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.

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 groups in NCT05580822
Study groupRoleWhat they receive
intra-arterial TNK infusion (0.4mg/min) via support/access catheter, over 15 minutesExperimentalNot described
Receives: Drug: Tenecteplase for Injection
intra-arterial TNK infusion (0.25mg/min) via support/access catheter, over 15 minutesExperimentalNot described
Receives: Drug: Tenecteplase for Injection
intra-arterial placebo infusion via support/access catheter, over 15 minutesPlacebo comparatorNot described
Receives: Drug: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. mRS 0-3

    The proportion of patients with a modified Rankin Scale 0 to 3 at 90 days

    Measured: 90 days

  2. symptomatic ICH

    The proportion of symptomatic ICH within 24 hours after allocated intervention

    Measured: 24 hours

Secondary outcomes (6)

  1. mRS 0-1

    The proportion of patients with a mRS 0 to 1 at 90 days

    Measured: 90 days

  2. mRS 0-2

    The proportion of patients with a mRS 0 to 2 at 90 days

    Measured: 90 days

  3. mRS shift

    The proportion of patients with a mRS shift at 90 days

    Measured: 90 days

  4. early neurological improvement

    The proportion of patients with early neurological improvement (NIHSS reduction > 4) at 48 hours

    Measured: 48 hours

  5. PH1 and PH2 sICH

    The proportion of subtypes (PH1 and PH2) of sICH within 24 hours after allocated intervention

    Measured: 24 hours

  6. 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.

  1. First posted14 Oct 2022
  2. Study start1 Jan 2023 (estimated)
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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)
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

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?

On the ClinicalTrials.gov record for NCT05580822.

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 uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in