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This is a randomized, placebo-controlled, phase 3 clinical trial to evaluate the efficacy and safety of transcranial ultrasound (US) as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in subjects with acute ischemic stroke.
Full description
The primary objective of this trial is to provide information regarding the efficacy of a combined treatment with transcranial US and systemic tPA (Target group) compared to systemic tPA alone (Control group) in subjects with acute ischemic stroke. The primary efficacy endpoint is functional outcome at 3 months from stroke onset (modified Rankin Score ordinal shift analysis). The primary safety endpoint is the proportion of subjects in the Target vs Control group experiencing symptomatic intracranial hemorrhage (sICH) within 24 hours of treatment.
Enrollment
Sex
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Inclusion criteria
Males or females 18 - 80 years of age
Subjects presenting within timeframe for intravenous tPA treatment approved by local regulatory authorities but no more than 4.5 hours from onset of symptoms
No signs of intracranial bleeding on assessment by non-contrast CT
Subjects with neurological deficits of a total NIHSS score ≥ 10 points
Subjects that in the opinion of the treating physician require treatment with full dose IV tPA as standard of care per institutional standards
SBP < 185 mmHg and DBP < 105 mmHg at baseline or after treatment of hypertension with medications prior to tPA bolus
Pre-morbid modified Rankin score of 0-1
Provision of informed consent as demonstrated by the subject's signature or by the signature of the subject's authorized legal representative on the Informed Consent Form in accordance with all local and national regulations
Co-signature on the Informed Consent Form by a qualified member of the study staff signifying that, in his/her professional opinion, informed consent has been obtained in accordance with all local and national regulations
For subjects in the optional arterial recanalization substudy:
Exclusion criteria
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675 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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