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NCT05684172

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

Completed Phase 2, PHASE3 Last updated 11 April 2024
What this trial tests

Phase 2, PHASE3 trial testing Tenecteplase in Acute Ischemic Stroke in 208 participants. Completed in 24 November 2023.

Timeline
24 January 2023
Primary endpoint
24 August 2023
24 November 2023

Quick facts

Lead sponsorThe First Affiliated Hospital of University of Science and Technology of China
PhasePhase 2, PHASE3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment208
Start date24 January 2023
Primary completion24 August 2023
Estimated completion24 November 2023
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

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

Who can join

18 and older, any sex, with Acute Ischemic Stroke or Intracranial Artery Occlusion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Comprehensive Review of Tenecteplase for Thrombolysis in Acute Ischemic Stroke.
    Wang L, Hao M, Wu N, Wu S, et al · · 2024 · cited 48× · PMID 38686848 · DOI 10.1161/jaha.123.031692
  2. Intra-arterial tenecteplase after successful endovascular recanalisation in patients with acute posterior circulation arterial occlusion (ATTENTION-IA): multicentre randomised controlled trial.
    Hu W, Tao C, Wang L, Chen Z, et al · · 2025 · cited 35× · PMID 39809509 · DOI 10.1136/bmj-2024-080489
  3. Intra-arterial alteplase for acute ischaemic stroke after mechanical thrombectomy (PEARL): rationale and design of a multicentre, prospective, open-label, blinded-endpoint, randomised controlled trial.
    Yang X, He X, Pan D, Xu Y, et al · · 2024 · cited 16× · PMID 39500603 · DOI 10.1136/bmjopen-2024-091059
  4. Intra-arterial tenecteplase following endovascular therapy in patients with acute posterior circulation arterial occlusion: study protocol and rationale.
    Tao C, Li R, Sun J, Zhu Y, et al · · 2024 · cited 15× · PMID 38124230 · DOI 10.1136/jnis-2023-021076
  5. Natural Evolution of Incomplete Reperfusion in Patients Following Endovascular Therapy After Ischemic Stroke.
    Mujanovic A, Windecker D, Cimflova P, Meinel TR, et al · · 2025 · cited 7× · PMID 39567366 · DOI 10.1161/strokeaha.124.049641
  6. Adjunctive Thrombolytics After Successful Endovascular Reperfusion: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
    Doheim MF, Mohammaden MH, Jumah A, Yang Q, et al · · 2025 · cited 6× · PMID 40799167 · DOI 10.1002/ana.70021
  7. Noncontrast CT vs CT Perfusion Imaging in Patients With Basilar Artery Occlusion: Analysis of the ATTENTION and ATTENTION IA Trials.
    Hu W, Nguyen TN, Qureshi M, Chen Z, et al · · 2025 · cited 2× · PMID 40674670 · DOI 10.1212/wnl.0000000000213911
  8. A Review on Adjunctive Therapies for Endovascular Treatment in Acute Ischemic Stroke.
    Goyal M, Rinkel LA, Ospel JM. · · 2023 · cited 2× · PMID 38025256 · DOI 10.5797/jnet.ra.2023-0035

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