Intensive Treatment of Blood Pressure in Acute Ischemic Stroke. Study TICA 2 (TICA)

This is an interventional treatment trial for Brain Ischemia focused on measuring Brain ischemia, Cerebral ischemia Read More

Inclusion Criteria:

• Men or women aged 18 years and up to and 85 years (both included).
• Clinical and neuroimaging diagnosis (CT or MRI) of ischemic stroke.
• Possibility of initiating antihypertensive treatment within 12 hours after the onset of symptoms (in the case of stroke, the start time is considered the time in that the patient has been seen asymptomatic for the last time).
• Participant with systolic blood pressure greater than or equal to 140 mm Hg and less than or equal to 220 mm Hg at the time of inclusion.
• Participant or legal representative able to understand the study requirements and sign Informed consent.

Exclusion Criteria:

• Uncontrollable hypertension (SBP greater than 220 mm Hg) or any condition requiring urgent antihypertensive treatment.
• Have suffered a stroke in the previous 90 days in the same territory as the current stroke.
• Had a myocardial infarction in the previous 90 days.
• Suspected aortic dissection or hypertensive encephalopathy.
• Presence of intracerebral or subarachnoid hemorrhage in basal neuroimaging (Computed tomography or magnetic resonance imaging).
• Recanalization is possible or intraarterial recanalization techniques have been performed due to the current stroke.
• Known critical carotid occlusion or stenosis.
• To be a candidate for carotid revascularization in the next three months.
• Previous alterations that, in the opinion of the investigator, may interfere in the interpretation of the neurological scales.
• Coma or low level of consciousness (defined as a score ≥ 2 in section 1.a of NIHSS), dementia or mental disability that, in the opinion of the investigator, patient is unable to participate in the study.
• Convulsive seizures at any time from the onset of symptoms to the initial evaluation.
• Neurological or non-neurological comorbidities that, in the opinion of the investigator, may lead, regardless of the current stroke, to a deterioration in the patient's neurologic status during the study period, or may hinder the evaluation of the neurological state caused only by stroke (i.e., metabolic encephalopathies, hemiplegic migraine, multiple sclerosis, central nervous system tumor, epilepsy, monocular blindness).
• Patient is likely to undergo a procedure involving extracorporeal circulation during the study period.
• Any condition that, in the opinion of the investigator, may compromise the patient's ability to complete the study (i.e., concomitant diseases that may threaten the patient's life, such as neoplasms or terminal failure of an organ).
• Patient's previous disability, determined by a score in modified Rankin scale > 1.
• Women of childbearing age with positive pregnancy test or breastfeeding at the time of inclusion.
• Women of childbearing potential (menopause less than 2 years old or not surgically sterilized) who are not going to take effective and adequate measures to avoid conception during the study period. Control measures include hormonal contraceptives, barrier methods such as diaphragm or intrauterine devices and / or spermicidal preservatives.
• Current dependence on substances of abuse such as alcohol, sympathomimetic amines, cannabis, cocaine, hallucinogens, opioids, phencyciclin, sedatives or hypnotics.
• Life expectancy is less than the expected duration of the clinical trial or any situation that, at the discretion of the investigator, may make participation in the clinical trial dangerous (eg drug use, alcohol addiction, etc.).
• Have received a drug or product under or participate in a clinical trial within 30 days prior to the date of inclusion in the study.