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

Primary Purpose

Basilar Artery Occlusion, Thrombectomy, Tenecteplase

Status

Not yet recruiting

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Tenecteplase for Injection

Saline

About this trial

This is an interventional treatment trial for Basilar Artery Occlusion

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
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.

Exclusion Criteria:

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
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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

intra-arterial TNK infusion (0.4mg/min) via support/access catheter, over 15 minutes

intra-arterial TNK infusion (0.25mg/min) via support/access catheter, over 15 minutes

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

Arm Description

Outcomes

Primary Outcome Measures

mRS 0-3

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

symptomatic ICH

The proportion of symptomatic ICH within 24 hours after allocated intervention

Secondary Outcome Measures

mRS 0-1

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

mRS 0-2

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

mRS shift

The proportion of patients with a mRS shift at 90 days

early neurological improvement

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

PH1 and PH2 sICH

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

mortality

The proportion of mortality at 90 days

Full Information

NCT ID

NCT05580822

First Posted

October 12, 2022

Last Updated

October 12, 2022

Sponsor

First Hospital of China Medical University

1. Study Identification

Unique Protocol Identification Number

NCT05580822

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 1, 2023 (Anticipated)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

First Hospital of China Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Basilar Artery Occlusion, Thrombectomy, Tenecteplase

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

520 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

intra-arterial TNK infusion (0.4mg/min) via support/access catheter, over 15 minutes

Arm Type

Experimental

Arm Title

intra-arterial TNK infusion (0.25mg/min) via support/access catheter, over 15 minutes

Arm Type

Experimental

Arm Title

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

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Tenecteplase for Injection

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Saline

Intervention Description

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

Primary Outcome Measure Information:

Title

mRS 0-3

Description

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

Time Frame

90 days

Title

symptomatic ICH

Description

The proportion of symptomatic ICH within 24 hours after allocated intervention

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

mRS 0-1

Description

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

Time Frame

90 days

Title

mRS 0-2

Description

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

Time Frame

90 days

Title

mRS shift

Description

The proportion of patients with a mRS shift at 90 days

Time Frame

90 days

Title

early neurological improvement

Description

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

Time Frame

48 hours

Title

PH1 and PH2 sICH

Description

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

Time Frame

24 hours

Title

mortality

Description

The proportion of mortality at 90 days

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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. Exclusion Criteria: 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 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.

12. IPD Sharing Statement

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

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