Estudio enmascarado, controlado con placebo, aleatorizado, piloto, de ApTOLL para el tratamiento de pacientes con ictus isquémico agudo a nivel pre-hospitalario, utilizando la escala RACE (Evaluación Rápida de la Oclusión Arterial)

Phase 1

• Conditions: Acute Ischemic Stroke (AIS); Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2023-504015-32-00
• Lead Sponsor: Aptatargets S.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-29
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Suspected acute LVO (Large Vessel Occlusion) stroke patients identified by a RACE scale score >4 at the pre-hospital setting, identified in non-stroke ready centers or primary health centers, prior to the initial transfer to a CSC., Patients located in Barcelona and Girona areas., Estimated randomization time <6 hours from symptom onset, as evaluated at the pre-hospital setting. For wake-up strokes, onset time will be considered as the time of symptoms first discovered. (Treatment start is defined as study drug administration)., Non-significant pre-stroke functional disability (modified Rankin Scale 0 - 2), as evaluated at the pre-hospital setting., Age =18 and =90 years old., In case of women of childbearing potential (WOCBP), they should confirm menstrual period and a negative highly sensitive urine or serum pregnancy test to be included. Additionally, those WOCBP enrolled in the trial should adopt highly effective methods for birth control (i.e. intrauterine device, bilateral tubal occlusion, vasectomized partner, or sexual abstinence) for a period of 7 days after dose. If this statement can not be confirmed, WOCBP will be excluded. * a woman is considered of childbearing potential (WOCBP) i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy).

Exclusion Criteria

Patients in a coma (NIHSS item of consciousness >1), Patients with unstable clinical status who require emergent life support care, Serious, advanced, or terminal illness with anticipated life expectancy of less than 6 months., Suspected LVO acute stroke patients identified at the Emergency Department of a stroke center or an intrahospital stroke., Subject participating in a study involving an investigational drug or device that would impact this study., Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations. This excludes patients who are severely demented, require constant assistance in a nursing home type setting or who live at home but are not fully independent in activities of daily living (toileting, dressing, eating, cooking and preparing meals, etc.)., Unlikely to be available for 90-day follow-up (e.g. no fixed home address, visitor from overseas), Evidence of active systemic infection, Pregnant or nursing (lactating) women.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified