Actively Recruiting
Randomization to Endovascular Treatment Alone or Preceded by Systemic Thrombolysis With Tenecteplase in Ischemic Stroke
Led by Hospital Moinhos de Vento · Updated on 2025-04-04
398
Participants Needed
13
Research Sites
265 weeks
Total Duration
On this page
Sponsors
H
Hospital Moinhos de Vento
Lead Sponsor
M
Ministry of Health, Brazil
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Randomization to Endovascular Treatment Alone or Preceded by Systemic Thrombolysis With Tenecteplase in Ischemic Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Acute ischemic stroke eligible for IV thrombolytic treatment within 4.5 hours of symptom onset
- No significant disability before stroke (modified Rankin Scale 1)
- NIH Stroke Scale score of 6 or higher before randomization
- Age between 18 and 85 years
- Blockage of the internal carotid artery or proximal middle cerebral artery suitable for endovascular treatment confirmed by imaging
- Randomization within 4.5 hours of symptom onset, with treatment start (groin puncture) within 90 minutes after randomization
- Informed consent provided by the patient or a legal representative
You will not qualify if you...
- Known bleeding disorder, coagulation factor deficiency, or use of blood thinners with INR > 1.7 or direct oral anticoagulants within 48 hours
- Platelet count below 100,000/bcL
- Blood glucose less than 50 mg/dL or greater than 400 mg/dL
- Severe high blood pressure (systolic > 185 mm Hg or diastolic > 110 mm Hg) unless controlled by medication
- Coma or severe impaired consciousness
- Seizures at stroke onset preventing baseline evaluation
- Serious illness with life expectancy under one year
- History of severe allergy to contrast medium
- Prior intravenous t-PA treatment before randomization
- Renal failure with serum creatinine 3 mg/dl
- Known pregnancy or positive pregnancy test on admission
- Participation in another investigational drug or device study affecting this trial
- Cerebral vasculitis, endocarditis, or subarachnoid hemorrhage
- Pre-existing neurological or psychiatric disease interfering with assessments
- Unlikely to be available for 90-day follow-up
- Large brain tissue damage on imaging exceeding one third of the middle cerebral artery territory
- ASPECTS score below 6 on imaging
- Evidence of brain hemorrhage (except minor microbleeds)
- Significant mass effect with midline brain shift
- Untreatable carotid artery occlusion, severe stenosis, arterial dissection, or vessel tortuosity preventing device delivery
- Multiple vascular territory occlusions
- Intracranial tumor (except small meningioma)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil, 90035000
Actively Recruiting
2
Hospital das Clínicas Botucatu
Botucatu, Brazil
Actively Recruiting
3
Hospital de Base do Distrito Federal
Brasília, Brazil
Actively Recruiting
4
Hospital das Clínicas da UFPR
Curitiba, Brazil
Actively Recruiting
5
Hospital Geral de Fortaleza
Fortaleza, Brazil
Actively Recruiting
6
Hospital de Clinicas de Porto Alegre
Porto Alegre, Brazil
Actively Recruiting
7
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Ribeirão Preto, Brazil
Actively Recruiting
8
Hospital de Base de Rio Preto
São José do Rio Preto, Brazil
Actively Recruiting
9
Hospital das Clínicas de São Paulo
São Paulo, Brazil
Actively Recruiting
10
Hospital Sao Paulo
São Paulo, Brazil
Actively Recruiting
11
Santa Casa de Misericordia de Sao Paulo
São Paulo, Brazil
Actively Recruiting
12
Hospital Universitário de Uberlândia
Uberlândia, Brazil
Actively Recruiting
13
Hospital Estadual Central
Vitória, Brazil
Actively Recruiting
Research Team
O
Octavio M Pontes-Neto, MD, PhD
CONTACT
L
Leonardo A Carbonera, MD, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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