EPICS‐Pilot 2020.

Study name	EPICS‐Pilot 2020
Methods	PROBE assessed randomised, parallel‐group pilot trial
Participants	Inclusion criteria: age ≥ 40 years; ischaemic stroke, confirmed by imaging (including TIA with imaging evidence of acute brain ischaemia; living at home and independent (walking without the aid of another person, but may have some help for daily activities – equivalent to Rankin score ≤ 3); SBP ≥ 130 mmHg at entry (mean of 2 measures, seated, after resting alone in office for 5 minutes); qualifying stroke/TIA between 7 days and 1 year of randomization. eGFR ≥ 50 mL/minute/m2; medically stable and capable of participating in a randomised trial, including home blood pressure measures, in the opinion of the study physician; willing to provide informed consent (no surrogate consent will apply). Exclusion criteria: stroke/TIA due to cardioembolism or other defined causes (e.g. dissection, endocarditis, other specified); severe stenosis of large cranio‐cervical artery (> 70% stenosis of cervical carotid, vertebral, or Circle of Willis artery); medical history of primary intracerebral haemorrhage (asymptomatic cerebral microbleeds detected on brain MRI are not excluded); SBP < 110 mmHg after 3 minutes of standing or other contraindication to intensive SBP lowering in opinion of treating clinician (e.g. syncope or presyncope, recurrent falls); unlikely to comply with study procedures (home blood pressure measures, follow‐up visits) due to severe or fatal comorbid illness (e.g. dementia, active malignancy, severe frailty) or other factor (e.g. inability to travel); women of child‐bearing potential.
Interventions	Standard target: SBP 130–139 mmHg Lower target: SBP 115–125 mmHg
Outcomes	Primary outcome: difference in achieved SBP. Secondary outcomes: time to first composite major vascular event; proportions of participants assigned to target goals successfully reaching target; number of dose‐titrations required; time in target range; loss to follow‐up; time taken to reach target range; change in cognition; change in Montreal cognitive assessment score (range 0–30) at last follow‐up compared with baseline score; quality of life score; change in EQ‐5D‐5L score; difference in mean achieved DBP between groups; change in SBP and DBP from baseline to end‐of‐trial; time required per follow‐up visit; feasibility of remote blood pressure titration; disability in intensive SBP and guideline‐based SBP target participants assessed by modified Rankin score (shift analysis and proportion with no, mild, or moderate disability, Rankin score 0–3); number of adverse events, serious adverse events, and suspected unexpected serious adverse reactions; number of prespecified adverse events; qualitative patient feedback obtained via workshops and questionnaires; total, direct and indirect (e.g. via lost income to study participants or family members) costs associated with face‐to‐face visits for study participants will be quantified.
Starting date	June 2021
Contact information	Katrina Tobin; +353 1 716 4576; katrina.tobin@ucd.ie
Notes	Responsible party: University College Dublin