Intensive Treatment of Blood Pressure in Acute Ischemic Stroke. Study TICA 2 (TICA)
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|ClinicalTrials.gov Identifier: NCT03491449|
Recruitment Status : Recruiting
First Posted : April 9, 2018
Last Update Posted : April 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Brain Ischemia||Procedure: Group A Procedure: Group B||Not Applicable|
Control of blood pressure figures remains one of the most important risk factors in primary and secondary prevention in patients with stroke. The current strategy for the hypertensive treatment of patients during the acute phase of ischemic stroke within the first 72 hours remains a highly debated and unclear issue, with no consensus on the range or appropriate blood pressure ranges to be handled (13).
Team study working hypothesis focuses on the study of blood pressure (for 72 hours), through its intensive control (recording and adjustment every four hours), in the acute phase of ischemic stroke. Specifically, it is based on the monitoring and maintenance of systolic blood pressure between 140 and 160 mm Hg in patients with acute ischemic stroke; And this can lead to a better functional prognosis, measured at 90 days, compared with the functional prognosis of patients treated according to the recommendations of the current Clinical Guidelines, which propose to act on systolic blood pressure only when it exceeds 185 mm Hg (13,22).
Although the intense decrease in blood pressure during the acute phase of stroke has the potential risk of decreasing cerebral perfusion in the area of ischemic penumbra, in recent observational studies (19), a worse functional prognosis has not been found in those patients With systolic blood pressure above 140 mm Hg.
There is no previous evidence from other intervention studies related to blood pressure control and a benefit to patients with acute ischemic stroke. Comparison using a randomized clinical trial of a group of patients with blood pressure control following current guidelines with a group of patients with systolic blood pressure between 140 and 160 mm Hg may allow a simple, rapidly applicable therapeutic alternative to Clinical practice, low cost and extrapolable to a wider population, such as patients with stroke of any etiology.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||National, multicenter, open, two-parallel groups, randomized 1: 1|
|Masking:||None (Open Label)|
|Official Title:||Intensive Treatment of Blood Pressure in Acute Ischemic Stroke. Study TICA 2|
|Actual Study Start Date :||February 13, 2017|
|Estimated Primary Completion Date :||February 13, 2019|
|Estimated Study Completion Date :||February 13, 2020|
Experimental: Group A: pressure ≥140 and ≤160mmHg
Intensive management of blood pressure, maintaining a systolic blood pressure ≥ 140 and ≤ 160 mm Hg for 72 hours.
Procedure: Group A
Maintaining a systolic blood pressure ≥ 140 and ≤ 160mm Hg for 72 hours.
Active Comparator: Group B: Keep systolic pressure <185mmHg
Intensive management of blood pressure, maintaining systolic blood pressure <185 mm Hg for 72 hours.
Procedure: Group B
Maintaining a systolic blood pressure <185mm Hg for 72 hours.
- Study of functional prognosis in patients with acute ischemic stroke using modified Rankin [ Time Frame: 90 days ]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.
- Early Neurological Impairment (ENI) [ Time Frame: 72 hours ]Increased at 4 or more points on the NIHSS scale in any determination during the first 72 hours compared to baseline score. NIHSS Scale: It is a scale that evaluates the neurological situation of the patient. The full name is "National Institute of Health Stroke Scale." The lowest score is 0, and the upper limit is 40. The lower score, the patient has fewer symptoms, and the higher score, the patient is more serious. It is considered that up to 8 points the patient has a mild stroke, between 8-15 a moderate stroke and more than 16 points a severe stroke.
- Volume of the infarct in neuroimaging [ Time Frame: 4th day ]Volume of the infarct in neuroimaging (CT or MRI) performed between the 4th and 7th day after the stroke. The volume in mL, using the formula a x b x c x 0.5, where "a" and "b" are the largest diameters perpendicular in centimeters and "c" the number of 1 cm cuts in which the infarct is seen.
- Mortality [ Time Frame: 90 days ]Any patient who dies from inclusion (signature of informed consent) until the final study visit (90 ± 15 days).
- Measuring the adverse events [ Time Frame: 90 days ]Measuring the adverse events occurring throughout the study.
- Volume of the infarct using NIHSS [ Time Frame: 7th day ]Increased at 4 or more points on the NIHSS scale in any determination during the first 72 hours compared to baseline score. NIHSS Scale: It is a scale that evaluates the neurological situation of the patient. The full name is "National Institute of Health Stroke Scale." The lowest score is 0, and the upper limit is 40. The lower score, the patient has fewer symptoms, and the higher score, the patient is more serious. It is considered that up to 8 points the patient has a mild stroke, between 8-15 a moderate stroke and more than 16 points a severe stroke.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491449
|Contact: Manuel Rodríguez, MDfirstname.lastname@example.org|
|Hospital Clínico Universitario de Santiago||Recruiting|
|Santiago de Compostela, A Coruña, Spain, 15706|
|Contact: Manuel Yañez, MD email@example.com|
|Hospital Universitario Álvaro Cunqueiro||Recruiting|
|Vigo, Pontevedra, Spain, 36312|
|Contact: José Luís Maciñeiras, MD firstname.lastname@example.org|
|Hospital Universitario A Coruña||Recruiting|
|A Coruña, Spain, 15006|
|Contact: Mª Dolores Fernandez, MD MA.Dolores.Fernandez.Couto@sergas.es|
|Principal Investigator:||Manuel Rodríguez, MD||Hospital Universitario de Santiago|