Low dOse combinaTions to improve stroke oUtcomeS (LOTUS)
Lead PIs: Dr Sonali Gnanenthiran, Prof Anthony Rodgers, Prof Timothy Kleinig, A/Prof Seana Gall & Prof Craig Anderson
Status: ASTN endorsed, Site start-up
No. of Participants Required: 400
LOTUS is expected to begin recruitment in April 2025
Participating Australian Sites
Royal Adelaide Hospital (SA)
John Hunter Hospital (NSW)
Royal North Shore Hospital (NSW)
Royal Melbourne Hospital (VIC)
Concord Hospital (NSW)
Sunshine Coast University Hospital (QLD)
We are actively seeking approximately 15 sites in urban and regional locations.
Overview
Primary aim: To assess whether an innovative blood pressure lowering triple pill, combined with regular nurse-led telehealth checkups, will help stroke survivors achieve and maintain better blood pressure control compared to patients who continue to receive usual care.
In addition, LOTUS will assess if this model of care improves medication adherence, is safe and cost-effective, and is well-received by patients and their doctors.
Design: Two-arm, open-label, multi-centre randomised controlled trial, with an optional factorial lipid lowering arm.
Intervention:
Novel low-dose single-pill-combination of telmisartan/amlodipine/indapamide (triple ¼, ½ and standard strengths: 10/1.25/0.625 mg, 20/2.5/1.25 mg, 40/5/2.5 mg), supported by nurse-led telehealth visits
+/- optional low-dose combination of rosuvastatin/ezetimibe (“set and forget”)
Comparator: Usual care
Primary Outcomes: Proportion of patients achieving blood pressure control (%), defined as clinic BP <130 mmHg at 26 weeks. For optional factorial: Proportion with LDL <1.8 mmol/l
Trial URL: In planning
Trial Registration: ANZCTR Registration No. ACTRN12624001279516
Contact: Lauren Kuhles, Associate Project Manager: lkuhles@georgeinstitute.org.au
