Acute ischemic stroke is caused by reduced blood supply to the brain associated with neuroinflammation. This mechanism contributes to acute neuronal death and persists even after reopening of the closed vessel, with consequent limitation of clinical and functional improvement. Experimental and clinical evidence demonstrated the anti-inflammatory and neuroprotective effect of micronized and ultramicronized Palmitoylethanolamide (PEA). The aim of this study is to evaluate the effect of co-ultramicronized PEA and luteolin (700 mg + 70 mg in 10 ml) on the clinical outcomes of patients with acute ischemic stroke undergoing mechanical thrombectomy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
60
oral suspension, 10 ml twice a day (every 12 hours) for 7 days
oral suspension,10 ml twice a day (every 12 hours) for 7 days
Endovascular Thrombectomy in all eligible patients, according to national acute stroke treatment guidelines
Azienda Sanitaria Universitaria Giuliano Isontina
Trieste, Italy, Italy
Change from baseline in the mean neurological disability score assessed by National Institutes of Health Stroke Scale (NIHSS), at 3 and 7 days (end of treatment) after hospitalization, between the two groups
NIHSS score ranges from 0 to 42, with higher scores indicating more severe neurological deficit
Time frame: Baseline-hospitalization, 3 and 7 days
Change from baseline in the mean functional disability score assessed by modified Rankin Scale (mRS), at 7 days after hospitalization, between the two groups
mRS consists of 6 grades from 0 to 5, with 0 corresponding to no symptoms and 5 corresponding to severe disability
Time frame: Baseline-hospitalization and 7 days
Incidence of death and/or major vascular events (recurrent strokes, myocardial ischemia or peripheral arterial ischemia) from baseline to 7 days after hospitalization, between the two groups
Time frame: From baseline to 7 days
Change from baseline of inflammatory and brain damage mediators [interleukin- 6 (IL-6), matrix metalloproteinase- 9 (MMP-9) and neurofilament light (NfL)] plasma levels at 3 and 7 days after hospitalization, between the two groups
Time frame: Baseline-hospitalization, 3 and 7 days
Volume of restored penumbra
Volume of initial penumbra on admission CT perfusion scans not evolved to ischemic lesion on follow-up CT scan at 72 hrs since stroke onset
Time frame: Baseline-hospitalization, 3 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.