Tenecteplase Before Interhospital Transfer for EVT in Acute Anterior Circulation LVO at 4.5-24 Hours

ConditionsAcute Ischemic Stroke Large Vessel Occlusion Transportation of Patients

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorXuanwu Hospital, Beijing

About this trial

This study will address the efficacy and safety of Tenecteplase administered in non-endovascular capable center (nECC) in patients with acute ischemic stroke (AIS) caused by anterior circulation large vessel occlusion (acLVO) who present in the 4.5- to 24-hour time window before interhospital transfer to an endovascular capable center (ECC) for endovascular treatment (EVT).

* Primary objective: To evaluate the efficacy and safety of Tenecteplase administration at a nECC before EVT transfer compared with standard of care * Secondary objective: To evaluate the impact of time from needle-to-arterial puncture on clinical outcomes Patients who meet inclusion criteria will be randomized to Tenecteplase (0.25mg/kg, maximum 25mg) before transfer or standard of care. A single bolus dose should be injected over 5 seconds.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age of 18 years or older;

AIS symptom onset to treatment initiation within 4.5 to 24 hours, stroke onset is defined as the time the patient was last known to be well (including wake-up stroke and unwitnessed stroke);

Signs and symptoms consistent with the diagnosis of an acute anterior circulation ischemic stroke involving occlusion of the internal carotid artery (ICA), M1 or proximal M2 vessels;

Functionally independent (mRS 0-2) prior to stroke onset;

Disqualifiers

Known hypersensitivity or allergy to any ingredients of Tenecteplase;

Intended to receive IVT as standard-of-care therapy;

Rapidly improving symptoms with NIHSS score <6 before randomization;

Any contra-indication for IVT except for the time criterion;

Trial design

Design model

Parallel

Treatments tested in this trial

Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg)
Drug
Tenecteplase at a nECC before EVT transfer

Treatment groups

572 Participants

are divided into 2 treatment groups

Group A: Tenecteplase before transferExperimental treatment 1 intervention

Group B: Standard of careNo intervention 0 interventions

Trial outcomes

Primary outcomes

Level of disability (ordinal mRS score)

the ordinal score on the modified Rankin scale; The modified Rankin scale is a measure of disability, with scores ranging from 0 (no symptoms) to 6 (death).

Time frame

at 90 (±7) days

Secondary outcomes

Excellent outcome

mRS of 0-1 vs. 2-6

Time frame

at 90 (±7) days

Functional independence

mRS of 0-2 vs. 3-6

Time frame

at 90 (±7) days

Ambulatory and self-care capable

mRS of 0-3 vs. 4-6

Time frame

at 90 (±7) days

Health-related quality of life

Score on the EuroQol Group 5-Dimension 5-Level \[EQ-5D-5L\] questionnaire; range, -0.39 to 1, with higher scores indicating better quality of life)

Time frame

at 90 (±7) days

Other outcomes

Symptomatic intracranial hemorrhage (sICH)

using Heidelberg criteria

Time frame

within 36 hours

Parenchymal hematoma type 2 (PH2)

Time frame

within 36 hours

All-cause mortality

Time frame

up to 90 (±7) days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xuanwu Hospital, Beijing

Lead sponsor

Boehringer Ingelheim (China) Investment Co., Ltd

Collaborator

Jeffrey Saver

Collaborator

Maarten Lansberg

Collaborator

Thanh N. Nguyen

Collaborator

Pierre Seners

Collaborator

Jens Fiehler

Collaborator

Raul G. Nogueira

Collaborator

Source ClinicalTrials.gov

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