Clinical Trials Directory

Trials / Unknown

UnknownNCT03491449

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
90 (estimated)
Sponsor
Manuel Rodríguez · Academic / Other
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Not accepted

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)

Detailed description

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREGroup AMaintaining a systolic blood pressure ≥ 140 and ≤ 160mm Hg for 72 hours.
PROCEDUREGroup BMaintaining a systolic blood pressure \<185mm Hg for 72 hours.

Timeline

Start date
2017-02-13
Primary completion
2019-02-13
Completion
2020-02-13
First posted
2018-04-09
Last updated
2018-04-09

Locations

3 sites across 1 country: Spain

Source: ClinicalTrials.gov record NCT03491449. Inclusion in this directory is not an endorsement.