Stroke, Acute Ischemic Clinical Trial
Official title:
Cerebroprotective Effect of Melatonin in Acute Ischemic Stroke
Stroke is a leading cause of mortality and disability in Mexico and worldwide. Although current treatment strategies focus on removing oclussion, they do not interrupt the signaling cascade of neuronal damage. Thus, the search for a cerebroprotective agent that can protect the entire brain. Melatonin has been proposed as a potential cerebroprotective agent due to its antioxidant, anti-inflammatory, antiapoptotic, and immunomodulatory effects, which oppose the pathophysiological mechanisms of cerebrovascular disease. Melatonin has the potential to improve stroke outcomes and reduce the risk of disability and mortality, making it a promising therapeutic option for stroke patients. To assess the efficacy of melatonin in patients with acute ischemic CVD, improve clinical outcome, and infarct volume.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | July 14, 2025 |
Est. primary completion date | March 15, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients presenting to the Emergency Department with acute ischemic CVD - Affiliated to the IMSS and ISSSTE, - Patients with NIHSS of 5-25 points - Patients with an evolution of less than 24 hours, - Patients over 18 years of age, - Patients with no history of disease that conditions neurological deficit prior to the event Exclusion Criteria: - Patients with cancer, rheumatic diseases, AIDS, immunological disease or conical infection, connective tissue diseases or CVD in the last 3 months, - Pregnant patients, with renal or hepatic insufficiency, allergic to iodine - Patients who receive thrombolytic - Patient who were taking illicit drugs the following medicine: Imipramine, Thioridazine, Cyproterone, Teriflunomide, Abiraterone acetate, deferasirox, obeticholic acid, peginterferon a2b, vemurafenib. Elimination Criteria: - Patients who have an allergic reaction to melatonin - Patients who do not keep follow-up appointments - Patients who wish to leave the study |
Country | Name | City | State |
---|---|---|---|
Mexico | Georgina Ortiz-Martínez | Morelia | Michoacan |
Lead Sponsor | Collaborator |
---|---|
Coordinación de Investigación en Salud, Mexico | Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado, Instituto Mexicano del Seguro Social, Universidad Michoacana de San Nicolás de Hidalgo |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in functional outcome and mortality | Is considered improvement, if present a decrease of NIHSS of 10 points on day 30, Or if you have one rating of 0-1 points before the day 7, from the start of symptoms. Is considered deterioration if NIHSS increases more than 4 points the first 5 days of the stroke. | 3 months | |
Secondary | Change in infarct volume | Evaluating the infarct volume size in the placebo and melatonin groups. RR and CI will be calculated. Each one of the parameters will determine effective if we get a RR>1 and a CI, which does not include 1. | 3 months | |
Secondary | Change in inflammatory biomarkers | It will be evaluated the magnitude of the association between the medication and the the desired effect, evaluating the anti-inflammatory (IL-6) effect between the placebo and melatonin groups. RR and CI will be calculated. Each one of parameters and will determine effective if we get a RR>1, and a CI which does not include 1. | 7 days | |
Secondary | Change in antiapoptotic biomarkers | It will be evaluated the magnitude of the association between the medication and the the desired effect, evaluating the antiapoptotic effect (Casp-3), between the placebo and melatonin groups. RR and CI will be calculated. Each one of parameters and will determine effective if we get a RR>1, and a CI which does not include 1. | 7 days | |
Secondary | Change in antioxidant biomarkers | It will be evaluated the magnitude of the association between the medication and the the desired effect, evaluating the antioxidant effect (SOD), between the placebo and melatonin groups. RR and CI will be calculated. Each one of parameters and will determine effective if we get a RR>1, and a CI which does not include 1. | 3 months | |
Secondary | Change endothelial damage | It will be evaluated the magnitude of the association between the medication and the the desired effect, evaluating the endothelial damage (FVW), between the placebo and melatonin groups. RR and CI will be calculated. Each one of parameters and will determine effective if we get a RR>1, and a CI which does not include 1. | 3 months |