Tenecteplase Before Interhospital Transfer for EVT in Acute Anterior Circulation LVO at 4.5-24 Hours
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
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), MCA (M1 or 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
Treatments tested in this trial
- Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg)
Treatment groups
572 Participants
are divided into 2 treatment groupsSponsors and collaborators
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