Tenecteplase Before Interhospital Transfer in Acute Basilar Artery Occlusion at 4.5 to 24 Hours
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorXuanwu Hospital, Beijing
About this trial
This study is designed to investigate the efficacy and safety of intravenous tenecteplase before interhospital transfer from a non-endovascular capable center(nECC) to an endovascular capable center (ECC) for thrombectomy in patients with acute ischemic stroke (AIS) caused by neuroimaging-confirmed acute basilar artery occlusion (BAO) between 4.5-24 hours of symptom onset.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years;
Patients presenting with posterior circulation ischemic stroke symptoms due to BAO;
BAO confirmed by computed tomographic angiography (CTA)/ magnetic resonance angiography (MRA);
Time from AIS symptom onset to randomization within 4.5-24 hours, stroke onset is defined as the onset of acute symptoms leading to the clinical diagnosis of basilar artery occlusion (BAO) not considering the time of any preceding minor prodromal symptoms (such as isolated vertigo, diplopia or sensory changes) as onset time or, if not known, the time the patient was last known to be well (including wake-up stroke and unwitnessed stroke);
Disqualifiers
Posterior Circulation Acute Stroke Prognosis Early CT score (PC-ASPECTS) < 6 on computed tomography (CT)/CTA-Source Images/MRI with diffusion-weighted imaging (DWI)
CT/MR shows evidence of intracranial hemorrhage and tumor (except small meningioma)
Complete cerebellar infarct on CT/MRI with significant mass effect and compression of the 4th ventricle
Bilateral extensive brainstem infarction on CT/MRI
Trial design
Design model
Parallel
Treatments tested in this trial
Tenecteplase thrombolysis
DrugPatients will receive intravenous Tenecteplase 0.25 mg/kg body-weight up to a maximum of 25mg before the transfer. A single bolus dose should be administered over 5-10 seconds based on patient weight. Transfer to ECCs for thrombectomy should be initiated immediately after Tenecteplase administration.
Treatment groups
316 Participants
are divided into 2 treatment groupsGroup A: Interventional groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Dichotomized mRS of 0-2 vs. 3-6
Dichotomized mRS of 0-2 vs. 3-6 at 90±7 days; modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)
Time frame
90±7 daysSecondary outcomes
1
Ordinal mRS score
Ordinal mRS score at 90 (±7) days; modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)
Time frame
90 (±7) days2
Dichotomized mRS of 0-1 vs. 2-6
Dichotomized mRS of 0-1 vs. 2-6 at 90 (±7) days
Time frame
90 (±7) days3
Dichotomized mRS of 0-3 vs. 4-6
Dichotomized mRS of 0-3 vs. 4-6 at 90 (±7) days
Time frame
90 (±7) days4
Early dramatic clinical response rate
Early dramatic clinical response rate at 24 (±12) h, defined as a NIHSS score of 0 or 2 or NIHSS drop of ≥8 from baseline
Time frame
24 (±12) hoursOther outcomes
1
Symptomatic intracranial hemorrhage （sICH）
Incidence of sICH (Heidelberg criteria) measured at 36 hours
Time frame
36 hours2
Parenchymal hematoma type 2 (PH2)
Incidence of PH2 at 36h
Time frame
36 hours3
All cause mortality
All-cause mortality up to 90 (±7) days.
Time frame
90 (±7) days.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov