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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)
EU CTIS ID: 2023-504015-32-00
What this study is testing
The objective of this randomized pilot trial is to evaluate if the administration of ApTOLL 0.2 mg/kg intravenously (i.v.) at the pre-hospital level (in the ambulance) is feasible, safe and effective in order to guide future pivotal trials.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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).
You likely can't join if
- 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.).
See the full eligibility criteria
Who can join
- 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).
What rules you out
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.