Additive Effects of Intra-arterial Tenecteplase for Successful Thrombectomy Due to Acute Basilar Artery Occlusion

NCT05580822 | Unknown Phase 2

• 1 other identifier: ARTERIAL-TNK-BAO-202201
• Study Type: interventional
• Target: 520
• Locations: 0 countries
• Sites: N/A

Brief 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). 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

Outcome Measures

Primary Outcomes (2)

• mRS 0-3

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

  90 days

• symptomatic ICH

  The proportion of symptomatic ICH within 24 hours after allocated intervention

  24 hours

Secondary Outcomes (6)

• mRS 0-1

  90 days

• mRS 0-2

  90 days

• mRS shift

  90 days

• early neurological improvement

  48 hours

• PH1 and PH2 sICH

  24 hours

Study Arms (3)

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

Interventions

Tenecteplase for Injection DRUG

intra-arterial TNK infusing after successful thrombectomy for patient with acute basilar artery occlusion via support/access catheter

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

Saline DRUG

intra-arterial saline infusing after successful thrombectomy for patient with acute basilar artery occlusion via support/access catheter

intra-arterial placebo infusion via support/access catheter, over 15 minutes

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Pre-morbid mRS ≤ 1；
• Patient or legal proxy is able to understand and willing to provide written inform and consent.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• First Hospital of China Medical University: lead

MeSH Terms

Interventions

Tenecteplase; Injections; Sodium Chloride

Intervention Hierarchy (Ancestors)

Tissue Plasminogen Activator; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Drug Administration Routes; Drug Therapy; Therapeutics; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 14, 2022
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: October 14, 2022

Record last verified: 2022-10