Because the PACESETTER trial was terminated prematurely due to COVID-19 and funding constraints, 'the effect of the PACESETTER intervention on 12-month BP control after stroke remains uncertain.'
Key Findings
Methods
The PACESETTER trial was stopped early due to low recruitment during COVID-19 and funding constraints, resulting in only 120 of the planned participants being enrolled.
Enrollment occurred between September 2019 and February 2023 across 3 safety-net health care systems in South Carolina.
120 participants were randomized 1:1: 60 to the PACESETTER intervention and 60 to usual care.
Early termination means the trial was underpowered for its primary outcome.
The trial targeted individuals residing in the southeastern United States, a region with disproportionately worse stroke outcomes.
Results
At 4 months, systolic BP control (<130 mm Hg) favored the PACESETTER intervention arm over usual care, though the difference did not reach statistical significance.
Systolic BP <130 mm Hg was achieved in 48.8% of PACESETTER participants versus 29.3% of usual care participants at 4 months.
The difference at 4 months yielded P=0.07, which did not meet conventional thresholds for statistical significance.
The PACESETTER intervention included a Bluetooth-enabled electronic pill tray, a BP monitor, and a smartphone application for automated data transmission.
Results
At 12 months, there was no significant difference in systolic BP control (<130 mm Hg) between the PACESETTER and usual care arms.
Systolic BP <130 mm Hg was achieved in 50% of PACESETTER participants versus 47.2% of usual care participants at 12 months.
The difference at 12 months yielded P=0.82, indicating no statistically significant effect.
The primary outcome was analyzed according to the intention-to-treat principle.
The lack of significance at 12 months must be interpreted in the context of the trial being underpowered due to early termination.
Background
Fewer than one third of stroke survivors achieve blood pressure control within 1 year of the index event in general practice.
This statistic was cited as a motivating factor for the PACESETTER trial.
Blood pressure reduction is described as 'among the most effective strategies for improving stroke outcomes.'
The trial specifically targeted patients with stroke and uncontrolled BP from safety-net health care systems.
Conclusions
The authors conclude that a fully completed, sufficiently powered trial is needed to evaluate the PACESETTER intervention, including key short-term endpoints.
The authors state: 'A trial completed to its full term and sufficiently powered to also evaluate key short-term end points is needed.'
The 4-month trend favoring PACESETTER suggests short-term endpoints may be important to capture in future trials.
The trial was registered at clinicaltrials.org with unique identifier NCT03401489.
What This Means
This research tested a technology-based program called PACESETTER to help stroke survivors in South Carolina control their blood pressure. The program gave participants a smart pill tray that tracked whether they took their medications, a blood pressure monitor, and a smartphone app that automatically sent their medication and blood pressure data to a central server. The goal was to see if this system could help more patients get their blood pressure below 130 mm Hg compared to patients receiving standard care, since uncontrolled blood pressure after stroke is very common and worsens outcomes.
The trial enrolled 120 participants but had to stop early because of recruitment difficulties during the COVID-19 pandemic and funding limitations. At the 4-month mark, nearly half of PACESETTER participants (48.8%) had achieved blood pressure control compared to about 29% in the usual care group, a promising difference that fell just short of statistical significance. However, by 12 months, both groups had similar rates of blood pressure control (50% vs. 47.2%), with no meaningful difference between them.
This research suggests that a technology-assisted approach to monitoring medication adherence and blood pressure after stroke may have early benefits, but the trial was too small and ended too soon to draw firm conclusions. The authors note that the southeastern United States has particularly poor stroke outcomes and that fewer than one-third of stroke survivors typically achieve blood pressure control within a year—making this an important public health problem. A larger, fully completed trial is needed to properly evaluate whether this type of intervention can meaningfully improve blood pressure control after stroke, particularly in underserved populations served by safety-net health systems.
Grewal P, Wabnitz A, Voeks J, Sen S, Trivedi T, Joseph C, et al.. (2026). Program to Avoid Cerebrovascular Events Through Systematic Electronic Tracking and Tailoring of an Eminent Risk Factor: A Randomized Trial.. Journal of the American Heart Association. https://doi.org/10.1161/JAHA.125.048147