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.
Prospective, multi-center, randomized, controlled, double blinded trial. 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. Randomization will be done under a minimization process using age (≤70 vs. \>70 years), baseline NIHSS (≤10 vs. \>10), therapeutic window (4.5-9 or 9-12 hours after TLKW), randomization scenario and clinical site. For the primary endpoint, subjects will be followed for 90 days post-randomization. The total sample size is 466 participants (233 in each arm). Interim analysis is planned with 40% and 67% of the total sample, with the possibility of stopping due to efficacy or futility, in addition to an adaptive design based on the conditional probability of a positive result.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
466
Intravenous tenecteplase (TNK). Patients will receive intravenous TNK (0.25mg/kg, maximum 25mg, administered as a bolus over 5 seconds).
Placebo matching IV TNK
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
RECRUITINGHospital das Clínicas Botucatu
Botucatu, Brazil
RECRUITINGHospital das Clínicas - UNICAMP
Campinas, Brazil
RECRUITINGHospital Universitário Maria Aparecida Pedrossian
Campo Grande, Brazil
RECRUITINGHospital das Clínicas UFPR
Curitiba, Brazil
RECRUITINGHospital Geral de Fortaleza
Fortaleza, Brazil
RECRUITINGClinica Neurologica e Neurocirurgica de Joinville
Joinville, Brazil
RECRUITINGHospital Metropolitano de Maceió
Maceió, Brazil
RECRUITINGHospital de Clínicas de Porto Alegre
Porto Alegre, Brazil
RECRUITINGHospital de Clínicas de Porto Alegre
Porto Alegre, Brazil
RECRUITING...and 5 more locations
Rates of Good Functional Outcomes adjusted for the baseline mRS and stroke severity (NIHSS) according to the modified Rankin Scale scores at 90 days
Rates of Good Functional Outcomes adjusted for the baseline mRS and stroke severity (NIHSS) according to the modified Rankin Scale scores at 90 days as following: Baseline mRS=0 and NIHSS \<10: mRs 90 days ≤1 Baseline mRS=1 and NIHSS ≥10: mRs 90 days ≤2
Time frame: 90 days
Rates of Excellent Outcome defined as mRS ≤ 1 and/ or equal to Baseline mRS at 90 days
Rates of Excellent Outcome defined as mRS ≤ 1 and/ or equal to Baseline mRS at 90 days
Time frame: 90 days
Rates of Independent Outcome defined as mRS ≤ 2 and/ or equal to Baseline mRS at 90 days
Rates of Independent Outcome defined as mRS ≤ 2 and/ or equal to Baseline mRS at 90 days
Time frame: 90 days
Mean score for disability on the utility-weighted modified Rankin scale (UW-mRS) at 90 days
Mean score for disability on the utility-weighted modified Rankin scale (UW-mRS) at 90 days
Time frame: 90 days
Final infarct volume (FIV) and infarct growth (FIV - baseline infarct on CTP or DWI) evaluated on CT or MRI at 3-5 days (if available)
Final infarct volume (FIV) and infarct growth (FIV - baseline infarct on CTP or DWI) evaluated on CT or MRI at 3-5 days (if available)
Time frame: 3-5 days
Final infarct volume (FIV) and infarct growth (FIV - baseline infarct on CTP or DWI) evaluated on CT or MRI at 24 hours (-2/+12 hours)
Final infarct volume (FIV) and infarct growth (FIV - baseline infarct on CTP or DWI) evaluated on CT or MRI at 24 hours (-2/+12 hours)
Time frame: 24 hours (-2/+12 hours)
Dramatic early favorable response as determined by an NIHSS of 0-2 or NIHSS improvement ≥ 4 points at 24 (-2/+12 hours) hours
Dramatic early favorable response as determined by an NIHSS of 0-2 or NIHSS improvement ≥ 4 points at 24 (-2/+12 hours) hours
Time frame: 24 (-2/+12 hours) hours
Quality of life analysis as measured by EuroQol/EQ5D at 3 month, 6 months and one year, between interventional therapy vs medical therapy alone
Quality of life analysis as measured by EuroQol/EQ5D at 3 month, 6 months and one year, between interventional therapy vs medical therapy alone
Time frame: 3 month, 6 months and one year
Brain tissue reperfusion evaluated by CT or MRI perfusion at 24 hours in both treatment groups (if available)
Brain tissue reperfusion evaluated by CT or MRI perfusion at 24 hours in both treatment groups (if available)
Time frame: 24 hours
Mortality at 90 days ( safety outcome)
Mortality at 90 days ( safety outcome)
Time frame: 90 days
Clinically significant ICH rates at 24 (-2/+12) hours.
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 modified SITS-MOST definition: local or remote parenchymal hemorrhage type 2, subarachnoid hemorrhage, and/or intraventricular hemorrhage on the post-treatment imaging scan, combined with a neurological deterioration of 4 points or more on the NIHSS from baseline, or from the lowest NIHSS value between baseline and 24 h, or leading to death that the CEC/DSMB judges is causative of the deterioration.
Time frame: 24 (-2/+12) hours
Incidence of any intracranial hemorrhage (Heidelberg criteria) measured at 24 (-2/+12)
Incidence of any intracranial hemorrhage (Heidelberg criteria) measured at 24 (-2/+12) hours
Time frame: 24 (-2/+12)
Distribution of the modified Rankin Scale scores at 90 days (shift analysis) as evaluated by two separate assessors at the central core lab) who are blinded to treatment.
Distribution of the modified Rankin Scale scores at 90 days (shift analysis) as evaluated by two separate assessors at the central core lab) who are blinded to treatment. Primary Endpoint will consider central core lab readings only (video interview with RFA method) with local reading as a back-up mechanism
Time frame: 90 days
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