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

NCT03491449 | Unknown

• 1 other identifier: MRY-IIA-2015-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

Brief Summary

Demonstrate that maintenance of systolic blood pressure between 140 and 160 mm Hg during the acute phase of ischemic stroke is more effective than management according to the International Guideline (treat when systolic blood pressure exceeds 185 mm Hg)

Conditions

Brain Ischemia

Keywords

Brain ischemia; Cerebral ischemia

Outcome Measures

Primary Outcomes (1)

• Study of functional prognosis in patients with acute ischemic stroke using modified Rankin

  Study of functional prognosis in patients with acute ischemic stroke using modified Rankin scale measured at 90 ± 15 days will compared between the two branches.Rankin Scale: It is a scale that evaluates the patient's functional situation. The full name is "modified Rankin Scale", and the abbreviated name is "mRS". The range of the scale is from 0 to 6, where 0 is the best score (the patient is asymptomatic) and 6 is the worst score (mortality). Up to 2 the patient is considered independent, and from 3 the patient needs help for the activities of daily life.

  90 days

Secondary Outcomes (5)

• Early Neurological Impairment (ENI)

  72 hours

• Volume of the infarct in neuroimaging

  4th day

• Mortality

  90 days

• Measuring the adverse events

  90 days

• Volume of the infarct using NIHSS

  7th day

Study Arms (2)

Group A: pressure ≥140 and ≤160mmHg

EXPERIMENTAL

Intensive management of blood pressure, maintaining a systolic blood pressure ≥ 140 and ≤ 160 mm Hg for 72 hours.

Procedure: Group A

Group B: Keep systolic pressure <185mmHg

ACTIVE COMPARATOR

Intensive management of blood pressure, maintaining systolic blood pressure \<185 mm Hg for 72 hours.

Procedure: Group B

Interventions

Group A PROCEDURE

Maintaining a systolic blood pressure ≥ 140 and ≤ 160mm Hg for 72 hours.

Group A: pressure ≥140 and ≤160mmHg

Group B PROCEDURE

Maintaining a systolic blood pressure \<185mm Hg for 72 hours.

Group B: Keep systolic pressure <185mmHg

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 or legal representative able to understand the study requirements and sign Informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Manuel Rodríguez: lead

Study Sites (3)

Hospital Clínico Universitario de Santiago

Santiago de Compostela, A Coruña, 15706, Spain

RECRUITING

Hospital Universitario Álvaro Cunqueiro

Vigo, Pontevedra, 36312, Spain

RECRUITING

Hospital Universitario A Coruña

A Coruña, 15006, Spain

RECRUITING

MeSH Terms

Conditions

Brain Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Manuel Rodríguez, MD

  Hospital Universitario de Santiago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manuel Rodríguez, MD

CONTACT

+34981950000; manyanez@yahoo.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: National, multicenter, open, two-parallel groups, randomized 1: 1

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: April 9, 2018
• Study Start: February 13, 2017
• Primary Completion: February 13, 2019
• Study Completion: February 13, 2020
• Last Updated: April 9, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)