Actively Recruiting
Randomization to Extend Stroke Intravenous ThromboLysis In Evolving Non-Large Vessel Occlusion With TNK (RESILIENT
Led by Hospital Moinhos de Vento · Updated on 2025-04-04
466
Participants Needed
15
Research Sites
284 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 clinical trial that will examine whether treatment with intravenous TNK is superior to placebo in patients who suffer a non-large vessel occlusion ischemic stroke within 4.5-12 hours from time last seen well. The randomization employs a 1:1 ratio of intravenous thrombolysis with Tenecteplase (TNK) versus placebo in patients who suffer a non-large vessel occlusion ischemic stroke between 4.5 and 12 hours from time last seen well (TLSW) and with a clinical-radiological mismatch or evidence of salvageable brain tissue on perfusion imaging.
CONDITIONS
Official Title
Randomization to Extend Stroke Intravenous ThromboLysis In Evolving Non-Large Vessel Occlusion With TNK (RESILIENT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Acute ischemic stroke with onset over 4.5 hours ago and no large vessel occlusion eligible for endovascular treatment
- No significant disability before stroke (modified Rankin Scale 2 or less)
- Age 18 years or older
- Evidence of clinical or imaging mismatch in distal artery territories based on specific scenarios
- Treatable within 4.5 to 12 hours of symptom onset
- Informed consent obtained from patient or acceptable surrogate
You will not qualify if you...
- Presence of intracranial hemorrhage on CT or MRI
- Rapidly improving symptoms judged to disqualify eligibility
- Pre-stroke modified Rankin Scale greater than 2
- Contraindications to MR or CT imaging with contrast
- Infarct core greater than one-third of MCA territory or over 50 mL
- Participation in another investigational study within 30 days
- Terminal illness with life expectancy less than 1 year
- Baseline platelet count below 100,000 per microliter
- Pregnant women or positive pregnancy test
- Stroke within the last three months
- Recent history or signs of hemorrhage, aneurysm, AV malformation, or cerebral tumor (except meningioma)
- Current use of oral anticoagulants with INR over 1.6
- Use of heparin (except low dose) within 48 hours and prolonged clotting time
- Use of glycoprotein IIb-IIIa inhibitors within past 72 hours
- Clinically significant low blood sugar
- Uncontrolled high blood pressure above defined limits
- Hereditary or acquired bleeding disorders
- Gastrointestinal or urinary bleeding within last 21 days
- Major surgery within last 14 days posing risk
- Exposure to thrombolytic agent within past 72 hours
- Participation in other investigational studies affecting this trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 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 das Clínicas - UNICAMP
Campinas, Brazil
Actively Recruiting
4
Hospital Universitário Maria Aparecida Pedrossian
Campo Grande, Brazil
Actively Recruiting
5
Hospital das Clínicas UFPR
Curitiba, Brazil
Actively Recruiting
6
Hospital Geral de Fortaleza
Fortaleza, Brazil, 60175-295
Actively Recruiting
7
Clinica Neurologica e Neurocirurgica de Joinville
Joinville, Brazil
Actively Recruiting
8
Hospital Metropolitano de Maceió
Maceió, Brazil
Actively Recruiting
9
Hospital de Clínicas de Porto Alegre
Porto Alegre, Brazil, 90035-007
Actively Recruiting
10
Hospital de Clínicas de Porto Alegre
Porto Alegre, Brazil
Actively Recruiting
11
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - Universidade de São Paulo
Ribeirão Preto, Brazil, 14015-010
Actively Recruiting
12
Hospital de Base São José do Rio Preto
São José do Rio Preto, Brazil
Actively Recruiting
13
Hospital São Paulo
São Paulo, Brazil, 04037-002
Actively Recruiting
14
Santa Casa de Misericordia de Sao Paulo
São Paulo, Brazil
Actively Recruiting
15
Hospital Estadual Central
Vitória, Brazil
Actively Recruiting
Research Team
G
Gisele Sampaio Silva, MD, MPH, PhD
CONTACT
L
Leonardo 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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