Cerebroprotective Effect of Melatonin in Stroke

• Status: Not yet recruiting
• Trial end date: 2025-05-14
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Coordinación de Investigación en Salud, Mexico
• Collaborators: Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado; Instituto Mexicano del Seguro Social; Universidad Michoacana de San Nicolás de Hidalgo
• Treatments: Melatonin

Criteria

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 α2b, 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