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
Qualifiers
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
Treatments tested in this trial
- Tenecteplase
- Placebo
Treatment groups
398 Participants
are divided into 2 treatment groupsSponsors and collaborators
Hospital Moinhos de Vento
Lead sponsor
Ministry of Health, Brazil
Collaborator
Boehringer Ingelheim
Collaborator
Medtronic
Collaborator
Source ClinicalTrials.gov