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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Active Comparator | co-ultramicronized Palmitoylethanolamide + Luteolin oral suspension (700 mg + 70 mg in 10 ml) in add-on to mechanical thrombectomy |
|
| Control group | Placebo Comparator | Placebo oral suspension in add-on to mechanical thrombectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| co-ultramicronized Palmitoylethanolamide + Luteolin (770 mg) | Dietary Supplement | oral suspension, 10 ml twice a day (every 12 hours) for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Baseline-hospitalization and 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marcello Naccarato, MD, PhD | Contact | +39 0403994569 | marcello.naccarato@asugi.sanita.fvg.it | |
| Paola Caruso, MD | Contact | +39 0403994569 | paola.caruso@asugi.sanita.fvg.it |
| Name | Affiliation | Role |
|---|---|---|
| Marcello Naccarato, MD, PhD | Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Sanitaria Universitaria Giuliano Isontina | Trieste | Italy | Italy |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000090862 | Neuroinflammatory Diseases |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D047311 | Luteolin |
| D017131 | Thrombectomy |
| ID | Term |
|---|---|
| D047309 | Flavones |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 |
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| Placebo | Other | oral suspension,10 ml twice a day (every 12 hours) for 7 days |
|
| Thrombectomy | Procedure | Endovascular Thrombectomy in all eligible patients, according to national acute stroke treatment guidelines |
|
| 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 | Baseline-hospitalization, 3 days |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |