Acute ischemic stroke MedDRA version: 19.0 Level: LLT Classification code 10055221 Term: Ischemic stroke System Organ Class: 100000004852
Conditions
Interventions
Trade Name: Trandate 5 mg/ml solution for injection
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: LABETALOL HYDROCHLORIDE
CAS Number: 32780-64-6
Trade Name: Elgadil 5mg/ml
Sponsors
Dr. Manuel Rodríguez Yáñez
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Men or women aged 18 and up to 85 years inclusive. • Diagnosis clinical and neuroimaging (CT or MRI) of ischemic stroke. • Ability to initiate antihypertensive treatment within 12 hours after the onset of symptoms (in the case of stroke, it is considered the start time as the time in which the patient has been asymptomatic last seen). • Participating with systolic blood pressure greater than or equal to 140 mm Hg and less than or equal to 220 mmHg at the time of inclusion. • Participant or able to understand the requirements of the study and sign the informed consent legal representative. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: • Uncontrollable hypertension (high SBP 220 mm Hg) or any condition that needs urgent antihypertensive treatment. • Having had a stroke in the last 90 days in the same territory as current stroke. • Having suffered a heart attack in the previous 90 days. • Suspected aortic dissection, or hypertensive encephalopathy. • Presence of intracerebral or subarachnoid hemorrhage in the basal neuroimaging (CT or MRI). • It is probable realization has been made or intra-arterial recanalization techniques by the current stroke. • Occlusion or critical carotid stenosis known. • Be a candidate for carotid revascularization in the next three months. • previous alterations that, according to the investigator, may interfere with the interpretation of neurological scales. • Eat or low level of consciousness (defined as a score = 2 in paragraph 1a of the NIHSS), dementia or mental impairment that judgment of the investigator makes the patient is unable to participate in the study. • Seizures at any time from the onset of symptoms to the initial assessment. • neurological or Comorbidities nonneurological that, according to the researcher, can carry, regardless of the current stroke, a deterioration in neurological status of the patient during the study period, or may hinder the evaluation of neurological status caused only by the stroke ( eg., metabolic encephalopathies, hemiplegic migraine, multiple sclerosis, tumor central, epilepsy, monocular blindness) nervous system. • Be likely to undergo a procedure involving extracorporeal circulation during the study period. • Any condition that, in the opinion of the investigator, would compromise the patient's ability to complete the study (eg. Comorbid conditions that may threaten the patient's life, such as neoplasms or terminal organ failure). • Disability previous patient, determined by a score on the mRS> 1. • Women of childbearing age with positive pregnancy test or lactating at the time of inclusion. • Women of childbearing age (menopause less than 2 years or not surgically sterilized) not going to make effective and appropriate measures to prevent conception during the study period. Control measures include hormonal contraceptives, barrier methods such as diaphragm or intrauterine devices and / or condoms with spermicide. • Current Unit substances of abuse such as alcohol, sympathomimetic amines, cannabis, cocaine, hallucinogens, opioids, fenciciclina, sedatives or hypnotics. • Life expectancy is less than the expected duration of the clinical trial or any situation which, in the opinion of the investigator, may make dangerous participation in the clinical trial (eg. Drug, alcohol addiction, etc ...). • Have received a drug or product under study or participate in a clinical trial within 30 days prior to the date of inclusion in the study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - early neurological deterioration (DNP): Increased 4 or more points on the NIHSS scale in any determination within 72 hours compared with baseline score. - infarct volume: infarct volume in neuroimaging (CT or MRI) between 4th-7th day after stroke is determined. the volume in mL is calculated using the formula a x b x c x 0.5, where "a" and "b" are the largest diameter perpendicular in centimeters and "c" the number of cuts of 1 cm in display infarction. - mortality: mortality shall be considered as any patient who dies from inclusion (signed informed consent) to the final study visit (90 ± 15 days) - assessment of the safety of administering riboflavin in patients with clinical suspicion of stroke is performed by measuring adverse events throughout the study.;Timepoint(s) of evaluation of this end point: - Early neurological deterioration: within first72 hours. - Volume of infarction: between 4th-7th day after the stroke. - Mortality: from inclusion to the final study visit (90 ± 15 days) - Security: all visits. | — |
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: - Demonstrate that the maintenance over 72 hours of systolic blood pressure between 140 and 160 mm Hg during the acute phase of ischemic stroke, determines a smaller percentage of early neurological deterioration, relative to conventional treatment according to international guidelines. - Demonstrate that the maintenance for 72 hours a systolic blood pressure between 140 and 160 mm Hg during the acute phase of ischemic stroke, reduces infarct volume (valued at neuroimaging at 24 hours) compared with conventional treatment according Guides international. - Demonstrate that the maintenance over 72 hours of systolic blood pressure between 140 and 160 mm Hg during the acute phase of ischemic stroke reduces mortality at 90 days measured relative to conventional management according to international guidelines. - Evaluate security between the two branches.;Main Objective: Demonstrate that maintaining systolic blood pressure between 140 and 160 mm Hg during the acute phase of ischemic stroke is more effective than management by Guidelines recommendation (try when systolic blood pressure 185 mm Hg exceeding).;Primary end point(s): Functional prognosis measured at 90 ± 15 days by modified Rankin scale.;Timepoint(s) of evaluation of this end point: 90 ± 15 days | — |
Countries
Spain
Contacts
Public ContactGeneral Director
Meditrial
Outcome results
None listed