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NCT Number: NCT05684172

Intra-arterial TNK Following Endovascular Thrombectomy in Patients With Large Vessel Occlusion of Posterior Circulation

Rationale: Recently, one prospective multicenter RCT reported a potential beneficial effect of intra-arterial alteplase following successful endovascular thrombectomy (EVT) in patients with an acute intracranial large vessel occlusion. In 2018, another prospective multicenter RCT supported the superiority of tenecteplase over alteplase in ischemic stroke patients with large vessel occlusion.

Objective: To assess the effect of EVT in addition to intra-arterial tenecteplase compared to EVT alone, in patients with large vessel occlusion of posterior circulation, on functional and safety outcomes.

Study design: This is a parallel group, randomized clinical trial of EVT with IA-TNK versus EVT. The trial has observer blind assessment of the primary outcome and of neuro-imaging at baseline and follow-up.

Study population: Patients with acute intracranial large vessel occlusion of posterior circulation and an eTICI 2b-3 after EVT.

Main study parameters/outcomes: The primary effect parameter will be excellent functional status at day 90 defined as a modified Rankin Score (mRS) of 0-1. The estimate will be adjusted for the known prognostic variables age, pre-stroke mRS, time from onset to randomization, stroke severity (NIHSS) and collaterals and adjusted and unadjusted estimates with corresponding 95% confidence intervals will be reported.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Endovascular Thrombectomy Intracranial Artery Occlusion Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine

Hefei, Anhui, 239300, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute ischemic stroke patients with symptomatic intracranial large vessel occlusion (LVO) in the intracranial vertebral artery, basilar artery, or the P1 segment of the posterior cerebral artery.
  • Treated with endovascular thrombectomy (EVT) resulting in an eTICI score 2b50/3 at end of the procedure.
  • Age of 18 years or older;
  • National Institutes of Health Stroke Scale (NIHSS) score on admission≥6;
  • Posterior Circulation ASPECTS ≥ 6 on CT/CTA-Source Images/MRI-DWI.
  • Time from estimated time of basilar artery occlusion to randomization<24 hours;
  • Written informed consent.

Exclusion criteria

  • Pre-existing dependency with mRS >1;
  • Contraindication to Intravenous Thrombolysis (except time to therapy);
  • Complete clinical recovery in the angiography suite by end of EVT procedure;
  • Pregnancy; if a woman is of childbearing potential a urine or serum beta HCG test is positive;
  • Severe contrast allergy or absolute contraindication to iodinated contrast;
  • Participation in other investigational drug or device clinical trials;
  • Systolic pressure >185 mmHg or diastolic pressure >110 mmHg, and cannot be controlled by antihypertensive drugs;
  • Known genetic or acquired bleeding diathesis, lack of anticoagulant factors, or oral anticoagulant drugs and INR > 1.7, or treated with direct oral anticoagulant agents in the prior 48 hours;
  • platelets <100 000/mm3, aPTT >40 s, or PT >15 s; Blood glucose < 2.7 or >22.2 mmol/L;
  • Severe renal Failure as defined by a serum creatinine > 3.0 mg/dl (or 265.2 μmol/l) or glomerular Filtration Rate [GFR] < 30, or patient requires hemodialysis or peritoneal dialysis;
  • Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal;
  • Suspicion of aortic dissection;
  • Presumed vasculitis or septic embolization;
  • Life expectancy < 1 year;
  • Patients that cannot complete 90-day follow-up (e.g. no fixed residence, overseas patients, etc.)；
  • CT/MR shows intracranial hemorrhage;
  • Ischemic stroke within 3 months;
  • Severe head trauma within 3 months;
  • Major surgery or severe trauma within the last 2 weeks.
  • History of prior intracranial hemorrhage.

Treatment and study plan

Tenecteplase

Drug

If patients are randomized and assigned to receive intra-arterial tenecteplase thrombolysis, tenecteplase will be injected according to protocol, proceeding to inject TNK through a distal access catheter or microcatheter located proximal to the residual thrombus (if still present) and distally to the origin of the pontine arteries.

endovascular thrombectomy alone

Other

Patients will receive randomization if the eTICI score on cerebral angiography is 2b-3 and will stop the procedure if they have been assigned to the control group.

Primary outcomes

  1. a modified Rankin Score of 0-1

    Time frame: 90 (± 14 days) after procedure

    modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)

Secondary outcomes

  1. a modified Rankin Score of 0-3

    Time frame: 90 (± 14 days) after procedure

    modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)

  2. Modified Rankin Score

    Time frame: 90 (± 14 days) after procedure

    modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)

  3. NIHSS score

    Time frame: 24 hours after procedure

    The NIHSS is an ordinal hierarchical scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit.

  4. mortality

    Time frame: 90 (± 14 days) after procedure

    (Number of subjects who died at 90-day follow-up/total number of subjects who participated in 90-day follow-up) x100%

  5. symptomatic intracerebral hemorrhage (ICH)

    Time frame: within 72 hours after procedure

    SICH means any hemorrhage with neurological deterioration, as indicated by an NIHSS score that was higher by ≥4 points than the value at baseline or the lowest value in the first 72 hours or any hemorrhage leading to death.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of University of Science and Technology of China

Other

Registry information

Official study title

Trial of Intra-arterial Tenecteplase Following Successful Endovascular Thrombectomy on Safety and Efficacy in Patients With Large Vessel Occlusion of Posterior Circulation - a Multicenter Randomized Clinical Trial (ATTENTION IA)

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 13, 2023
Registry last updated
Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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