Randomization to Endovascular Treatment Alone or Preceded by Systemic Thrombolysis With Tenecteplase in Ischemic Stroke
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorHospital Moinhos de Vento
About this trial
A phase III randomized, multi-center, double-blinded, placebo-controlled clinical trial that will examine two strategies for the treatment of acute ischemic stroke associated with a large vessel anterior occlusion within 4.5 hours from symptoms onset: direct endovascular treatment vs. endovascular treatment preceded by intravenous tenecteplase.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Acute ischemic stroke where a patient is eligible for IV thrombolytic treatment within 4.5 hours of stroke onset.
No significant pre-stroke functional disability (mRS ≤ 1)
Baseline NIHSS scores obtained before randomization must be equal to or higher than 6 points
Age equal ≥ 18 and =< 85 years
Disqualifiers
Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 1.7 or direct oral anticoagulants such as thrombin antagonists (ex: dabigatran) or X factor (ex: rivaroxaban, apixaban, edoxaban) at the least 48 hours.
Baseline platelet count < 100.000/μL
Baseline blood glucose of < 50mg/dL or > 400mg/dl
Severe, sustained hypertension (SBP > 185 mm Hg or DBP > 110 mm Hg) NOTE: If the blood pressure can be successfully reduced and maintained at the acceptable level using AHA guidelines recommended medication (including iv antihypertensive drips), the patient can be enrolled.
Trial design
Design model
Parallel
Treatments tested in this trial
Tenecteplase
DrugIntravenous thrombolysis with tenecteplase 0.25mg/kg
Placebo
DrugIntravenous administration of placebo, matching the volume of tenecteplase 0.25mg/kg
Treatment groups
398 Participants
are divided into 2 treatment groupsGroup A: Mechanical Thrombectomy preceded by TNKExperimental treatment 1 intervention
Group B: Mechanical Thrombectomy preceded by PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Distribution of the modified Rankin Scale scores at 90 days
Distribution of the modified Rankin Scale scores (shift analysis).
Time frame
90 daysSecondary outcomes
1
Functional independence defined as modified Rankin Score ≤ 2
Functional independence defined as modified Rankin Score ≤ 2
Time frame
90 days2
Infarct volume evaluated on CT at 24 hours (-2/+12 hours).
Infarct volume evaluated on CT at 24 hours (-2/+12 hours).
Time frame
24 hours3
Dramatic early favorable response as determined by a National Institute of Health Stroke Scale (NIHSS) of 0-2 or NIHSS improvement ≥ 10 points at 24 (-2/+12 hours) hours.
Dramatic early favorable response as determined by a National Institute of Health Stroke Scale of 0-2 or NIHSS improvement ≥ 10 points at 24 (-2/+12 hours) hours.
Time frame
24 hours4
Cost-effectiveness analysis of endovascular therapy alone vs. endovascular therapy associated with tenecteplase
Cost-effectiveness analysis of endovascular therapy alone vs. endovascular therapy associated with tenecteplase
Time frame
12 monthsOther outcomes
1
Mortality at 90 days
Mortality at 90 days
Time frame
90 days2
Mortality related to stroke and complications at 90 days
Mortality related to stroke and complications at 90 days
Time frame
90 days3
Clinically significant ICH rates at 24 (-2/+12) hours.
All intracerebral hemorrhages will be classified by a central core-lab using the ECASS criteria. Symptomatic ICH will be defined as per the SITS-MOST definition: deterioration in NIHSS score of ≥4 points within 24 hours from treatment and evidence of intraparenchymal hemorrhage type 2 in the 22 to 36 hours follow-up imaging scans. The incidence of any asymptomatic hemorrhage measured at 24 (-2/+12) hours will also be compared.
Time frame
24 hours4
Procedural related complications
arterial perforation, arterial dissection, and embolization in a previously uninvolved vascular territory
Time frame
7 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hospital Moinhos de Vento
Lead sponsor
Ministry of Health, Brazil
Collaborator
Boehringer Ingelheim
Collaborator
Medtronic
Collaborator
Source ClinicalTrials.gov