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PreprintCC BY-NC-NDmedRxiv

Low-Dose Tenecteplase for Acute Ischemic Stroke Treatment in Aging Patients DATE-AGING Trial: Rationale and Design

  • Z. Zhou1
  • X. Hou
  • S. Mi
  • X. Chen
  • Y. He
  • L. Chen
  • Q. Liu
  • J. Wu
  • T. Lv
  • L. Kong
  • R. Xu
  • M. Wu
1 more authors
  • D. Wang
  1. 1Department of Neurology, First Affiliated Hospital of Army Medical University (Southwest Hospital), Chongqing, China
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Abstract

BackgroundDespite the high stroke burden in the elderly, their thrombolysis utilization is suboptimal partly due to heightened hemorrhagic risk. Observational data suggest that low-dose thrombolysis may offer comparable efficacy to standard-dose with a trend toward reduced symptomatic intracranial hemorrhage (sICH), yet high-level evidence for low-dose thrombolysis in this broad population remains absent.

ObjectiveTo evaluate the safety and efficacy of low-dose intravenous tenecteplase thrombolysis in elderly stroke patients within 4.5 hours of ischaemic stroke onset.

Methods and designThe DATE-AGING trial is a multicenter, prospective, randomized, open-label, blinded-end point (PROBE) non-inferiority study. Eligible participants are elderly patients (aged [≥]70 years) with acute ischemic stroke who meet current guideline recommendations for intravenous thrombolysis within 4.5 hours of symptom onset will be randomly assigned to Low-dose Tenecteplase group (0.175 mg/kg, max 17.5 mg) or Standard-dose Tenecteplase group (0.25 mg/kg, max 25 mg). The primary outcome is excellent functional outcome, defined as modified Rankin Scale(mRS) 0-1 at 90 days. Safety outcomes include sICH within 36 hours and mortality at 90 days.

DiscussionsThe DATE-AGING trial is intended to provide high-quality evidence for low-dose tenecteplase intravenous thrombolysis in elderly patients with acute ischemic stroke.

Trial registry numberNCT07294209.

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Cite

BibTeXRIS
BibTeX
@misc{zhou2026lowdose,
  title = {{Low-Dose Tenecteplase for Acute Ischemic Stroke Treatment in Aging Patients DATE-AGING Trial: Rationale and Design}},
  author = {Z. Zhou and X. Hou and S. Mi and X. Chen and Y. He and L. Chen and Q. Liu and J. Wu and T. Lv and L. Kong and R. Xu and M. Wu and D. Wang},
  howpublished = {medRxiv},
  year = {2026},
  month = oct,
  doi = {10.64898/2026.10.08.26361416},
  url = {https://www.medrxiv.org/content/10.64898/2026.10.08.26361416v1},
  note = {CC BY-NC-ND},
}
RIS
TY  - UNPB
TI  - Low-Dose Tenecteplase for Acute Ischemic Stroke Treatment in Aging Patients DATE-AGING Trial: Rationale and Design
AU  - Z. Zhou
AU  - X. Hou
AU  - S. Mi
AU  - X. Chen
AU  - Y. He
AU  - L. Chen
AU  - Q. Liu
AU  - J. Wu
AU  - T. Lv
AU  - L. Kong
AU  - R. Xu
AU  - M. Wu
AU  - D. Wang
PY  - 2026
DA  - 2026/10/08
PB  - medRxiv
DO  - 10.64898/2026.10.08.26361416
UR  - https://www.medrxiv.org/content/10.64898/2026.10.08.26361416v1
AB  - BackgroundDespite the high stroke burden in the elderly, their thrombolysis utilization is suboptimal partly due to heightened hemorrhagic risk. Observational data suggest that low-dose thrombolysis may offer comparable efficacy to standard-dose with a trend toward reduced symptomatic intracranial hemorrhage (sICH), yet high-level evidence for low-dose thrombolysis in this broad population remains absent.  ObjectiveTo evaluate the safety and efficacy of low-dose intravenous tenecteplase thrombolysis in elderly stroke patients within 4.5 hours of ischaemic stroke onset.  Methods and designThe DATE-AGING trial is a multicenter, prospective, randomized, open-label, blinded-end point (PROBE) non-inferiority study. Eligible participants are elderly patients (aged [≥]70 years) with acute ischemic stroke who meet current guideline recommendations for intravenous thrombolysis within 4.5 hours of symptom onset will be randomly assigned to Low-dose Tenecteplase group (0.175 mg/kg, max 17.5 mg) or Standard-dose Tenecteplase group (0.25 mg/kg, max 25 mg). The primary outcome is excellent functional outcome, defined as modified Rankin Scale(mRS) 0-1 at 90 days. Safety outcomes include sICH within 36 hours and mortality at 90 days.  DiscussionsThe DATE-AGING trial is intended to provide high-quality evidence for low-dose tenecteplase intravenous thrombolysis in elderly patients with acute ischemic stroke.  Trial registry numberNCT07294209.
ER  -