Abstract
Background
Individuals residing in the southeastern United States experience disproportionately worse stroke outcomes. Although blood pressure (
BP
) reduction is among the most effective strategies for improving stroke outcomes, fewer than one third of survivors of stroke achieve
BP
control within 1 year of the index event.
Methods
The PACESETTER (Program to Avoid Cerebrovascular Events Through Systematic Electronic Tracking and Tailoring of an Eminent Risk Factor) trial enrolled patients with stroke and uncontrolled BP from 3 safety‐net health care systems in South Carolina. Patients were randomized 1:1 to the PACESETTER intervention, which included a Bluetooth‐enabled electronic pill tray, a BP monitor, and a smartphone application for automated data transmission of medication adherence and BP data to a central server or to usual care. The primary outcome was systolic BP
Results
The trial was stopped early due to low recruitment during the COVID‐19 and funding constraints. Between September 2019 and February 2023, 120 participants were randomized to PACESETTER (n=60) or the usual care arm (n=60). At 4 months, systolic BP P
=0.07), but no significant difference was observed at 12 months (50% versus 47.2%,
P
=0.82).
Conclusions
Because the trial was terminated prematurely, the effect of the PACESETTER intervention on 12‐month BP control after stroke remains uncertain. A trial completed to its full term and sufficiently powered to also evaluate key short‐term end points is needed.
Registration
URL:
https://www.clinicalstrial.org
; Unique Identifier: NCT03401489.