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American Heart Association

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Final ID: OGCTP22

Randomization to Endovascular Treatment Alone or Preceded by Systemic Thrombolysis With TNK in AIS due to LVO - RESILIENT DIRECT-TNK

Abstract Body: Background and Aims
Recent studies have questioned the benefit of IV thrombolysis with alteplase before mechanical thrombectomy (MT) in acute ischemic stroke (AIS) patients with large vessel occlusion (LVO). Other studies suggested that tenecteplase (TNK) before MT might provide higher recanalization rates than alteplase.

Methods
Randomized, prospective, multicenter, placebo-controlled clinical trial in patients with AIS due to LVO of the anterior circulation (ICA, MCA-M1, or MCA-M2) below 4.5 hours from symptoms onset. Randomization is 1:1 according to reperfusion treatment modalities: (A) direct mechanical thrombectomy (placebo-controlled) vs. (B) Intravenous thrombolysis with TNK (0.25 mg/kg) plus mechanical thrombectomy. The primary outcome is the ordinal distribution from the modified Rankin scale (mRS) at 90 days.

Results
The study recruitment is ongoing, with the final analysis planned for late 2026. The study includes 390 patients with completed 90-day follow-ups. Enrollment is ongoing at 15 sites. Until October 2024, 172 patients have been enrolled.

Conclusion
The RESILIENT DIRECT TNK trial will evaluate the hypothesis that in AIS patients with anterior LVO < 4.5 hours of symptoms, MT preceded by TNK is superior to MT alone, achieving more favorable outcomes measured by mRS scores at 90 days. This study is supported by Boehringer Ingelheim (BI) and Medtronic for providing the drug/placebo and devices, respectively. BI and Medtronic have no role in the results' design, analysis, or interpretation. BI was allowed to review the manuscript for medical and scientific accuracy and intellectual property considerations. This research is funded through PROADI-SUS, Hospital Moinhos de Vento. ClinicalTrials.gov registry: NCT05199194.
  • Pontes-neto, Octavio  ( UNIVERSITY OF SAO PAULO , Ribeirao Preto , Brazil )
  • Nogueira, Raul  ( University of Pittsburgh , Pittsburgh , Pennsylvania , United States )
  • Martins, Sheila  ( HOSPITAL CLINICAS DE PORTO ALEGRE , Porto Alegre , Brazil )
  • Sampaio, Gisele  ( UNIFESP and ALBERT EINSTEIN , Sao Paulo , Brazil )
  • Abud, Daniel  ( Hospital Das Clinicas Fmrp Usp , Ribeirao Preto , Brazil )
  • Carbonera, Leonardo  ( Hospital Moinhos de Vento , Porto Alegre , Brazil )
  • De Souza, Ana  ( HOSPITAL MOINHOS DE VENTO , Porto Alegre , Brazil )
  • Lima, Fabricio  ( Hospital Geral de Fortaleza , Fortaleza , Brazil )
  • Montalverne, Francisco Jose  ( Hospital Geral de Fortaleza , Fortaleza , Brazil )
  • Wagner, Mario  ( MWC , Porto Alegre , Brazil )
  • Author Disclosures:
    Octavio Pontes-Neto: DO have relevant financial relationships ; Speaker:Boehringer-Ingelheim:Active (exists now) ; Advisor:BMS:Active (exists now) ; Advisor:Bayer:Active (exists now) ; Advisor:RAPIDIA:Active (exists now) ; Advisor:ALLM:Active (exists now) ; Speaker:AstraZeneca:Active (exists now) | Raul Nogueira: DO have relevant financial relationships ; Consultant:Stryker:Active (exists now) ; Consultant:Phenox:Active (exists now) ; Individual Stocks/Stock Options:Vesalio:Active (exists now) ; Individual Stocks/Stock Options:Rapid Pulse:Active (exists now) ; Individual Stocks/Stock Options:Euphrates :Active (exists now) ; Individual Stocks/Stock Options:Brainomix:Active (exists now) ; Individual Stocks/Stock Options:Viz.AI:Active (exists now) ; Consultant:Perfuze:Active (exists now) ; Consultant:Route 92:Active (exists now) ; Consultant:Imperative Care:Active (exists now) ; Consultant:Microvention:Active (exists now) ; Consultant:Medtronic :Active (exists now) ; Consultant:Cerenovus:Active (exists now) | Sheila Martins: DO have relevant financial relationships ; Speaker:Boehringer Ingelheim:Active (exists now) ; Research Funding (PI or named investigator):Ministry of Health of Brazil:Active (exists now) ; Speaker:Daiichi Sankyo:Past (completed) ; Speaker:Pfizer:Past (completed) ; Speaker:Bayer:Past (completed) ; Speaker:Servier:Past (completed) ; Speaker:Novo Nordisk:Past (completed) ; Speaker:Novartis:Past (completed) ; Speaker:Penumbra:Past (completed) ; Speaker:Astra Zeneca:Active (exists now) ; Speaker:Medtronic:Active (exists now) | Gisele Sampaio: DO NOT have relevant financial relationships | Daniel Abud: No Answer | Leonardo Carbonera: DO have relevant financial relationships ; Advisor:Allm Inc:Active (exists now) ; Other (please indicate in the box next to the company name):Servier - Travel Grant:Past (completed) ; Advisor:ISchemaView:Active (exists now) ; Speaker:Boehringer Ingelheim:Past (completed) ; Speaker:AstraZeneca:Past (completed) ; Research Funding (PI or named investigator):Angels Initiative / Boehringer Ingelheim:Active (exists now) | Ana De Souza: DO NOT have relevant financial relationships | Fabricio Lima: No Answer | Francisco Jose Montalverne: No Answer | Mario Wagner: No Answer
Meeting Info:
Session Info:

Ongoing Clinical Trials Posters

Thursday, 02/06/2025 , 07:00PM - 07:30PM

Poster Abstract Session

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