Control of blood pressure in stroke

Phase 1

• Conditions: Acute ischemic stroke; MedDRA version: 19.0Level: LLTClassification code 10055221Term: Ischemic strokeSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-005776-24-ES
• Lead Sponsor: Dr. Manuel Rodríguez Yáñez

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-01
• Last Update Posted: 31 October 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

• 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.

Study & Design

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