Home blood pressure measurement, telemonitoring and medication titration for secondary prevention of ischaemic stroke: study protocol for a PROBE randomised controlled pilot and feasibility study

<ns3:p> Background Hypertension is a key risk factor for stroke, and elevated blood pressure (BP) is associated with an increased risk of recurrence following ischaemic stroke or transient ischaemic attack (TIA). European Stroke Organisation (ESO) guidelines recommend office BP reduction for secondary prevention to systolic BP (SBP) <130mmHg. However, high rates of failure to achieve guideline BP targets are reported. The benefit of SBP reduction in certain groups (eg. older patients), and to even lower levels, remains uncertain. Home blood pressure measurement with telemonitoring (HBPM-TM) is a promising strategy to improve guideline compliance, and to evaluate safety of very low SBP targets. However, few data exist on HBPM-TM after ischaemic stroke or TIA. Methods European blood Pressure Intensive Control after Stroke (EPICS)-Pilot is a prospective, open-label, blinded endpoint assessed (PROBE) randomised, parallel group pilot and feasibility clinical trial. The study compares the efficacy of HBPM-TM plus protocol-guided titration of antihypertensive medication versus usual care, to achieve guideline-based SBP targets, and to assess the safety and tolerability of intensive SBP reduction. Included patients enrolled from acute hospitals have ischaemic stroke or high-risk TIA and SBP≥130mmHg at baseline. Participants in the intervention group will return home measures via smartphone app or mail, and the study team will titrate medications according to a defined algorithm. The primary outcome will be the difference in mean SBP office measurement between the intervention and control arms at 3 months. Target recruitment is 142 patients (71 per arm). Secondary outcomes include feasibility of recruitment, retention, and feasibility and acceptability of the intervention. Safety data will be reported. Discussion HBPM-TM with medication titration may improve BP control for ischaemic stroke and TIA patients. Our trial will determine if this study design is suitable for a larger phase 3 efficacy study, as well as testing specific study tasks for feasibility. Trial registration ClinicalTrials.gov NCT04647292. Registered 20 <ns3:sup>th</ns3:sup> November 2020, <ns3:ext-link xmlns:ns4="http://www.w3.org/1999/xlink" ext-link-type="uri" ns4:href="https://clinicaltrials.gov/study/NCT04647292">https://clinicaltrials.gov/study/NCT04647292</ns3:ext-link> . Protocol Version Number V5, 06/06/2024. </ns3:p>