Tenecteplase Compared to Alteplase for Patients With Large Vesel Oclusion Suspicion Before Thrombectomy
Status:
Recruiting
Trial end date:
2024-05-01
Target enrollment:
Participant gender:
Summary
Background: The TNKCAT trial represents an innovative approach to optimize timely reperfusion
in the Mothership and Drip-and-Ship scenarios. The logistic advantage of a single bolus
infusion of TNK (compared to 1-h infusion of tPA) would markedly reduce the needle-to-groin
and Door-in- door-out time. The implementation of a quality improvement package (QIP) in the
TNKCAT trial would directly improve the quality and efficiency of the Health Care System. In
addition, an improvement of transfer models would reduce the cost of unnecessary transfers,
together with the fact that TNK is up to 50% less expensive than tPA, makes the TNKCAT in
firm line with the sustainability strategy of the National Health Care system.
Outcomes: The aim of the present study is to determine the safety and efficacy of TNK
(0.25mh/kg) compared to tPA (0.9 mg/kg) in patients with Large Vessel Occlusion (LVO)
suspicion, candidates for thrombectomy, in both Mothership and Drip-and-Ship scenarios.
Study Duration: 2 years. Patients will participate in the trial for 3 months.
Study design: Multicentre, prospective, randomized open-label blinded endpoint (PROBE) phase
III study in acute stroke patients with LVO suspicion within 4.5 hours of stroke onset,
candidates for EVT. Patients will be randomized 1:1 to standard dose tPA (0.9 mg/kg) or TNK
(0.25mg/kg) before EVT.
Clinical, imaging and outcome data will be collected at baseline, 24-36 hours, day 3, day 5
and day 90.
Estimated enrollment: 500 patients
Phase:
Phase 3
Details
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute