RecruitingPhase 3ACTRN12624001279516

efficacy of LOw dose antihypertensive and lipid lowering pill combinations To improve stroke oUtcomeS (LOTUS)

A randomised trial to compare outcomes on hypertension and hypercholesterolaemia with single pill combination based therapy and telehealth intervention vs standard care in survivors of ischaemic stroke/transient ischaemic attack.

Sponsor

The George Institute for Global Health Australia

Enrollment

400 participants

Start Date

Oct 23, 2025

Study Type

Interventional

Conditions

Hypercholesterolaemia Hypertension Transient Ischaemic Attack Ischaemic Stroke

Summary

LOTUS is an investigator-initiated and nurse-led trial with a two-arm, open-label, randomised, multicentre design. Low dose combination therapies for treatment of hypertension and (optional factorial arm) hypercholesterolaemia will be compared to usual care in stroke survivors over 26 weeks. The primary aim of LOTUS is to assess whether an innovative model of care involving low dose antihypertensive (and optionally) lipid lowering treatment underpinned by team-based, telehealth-supported care will reduce BP over 26 weeks when compared to usual care in survivors of ischaemic stroke/transient ischaemic attack (TIA). Secondary aims include if this new model (when compared to usual care): reduces cholesterol, is acceptable to patients and clinicians, is cost-effective, improves medication adherence and patient acceptability, and is safe.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

After a stroke or transient ischaemic attack (TIA — sometimes called a mini-stroke), the risk of having another stroke is significantly elevated. Managing blood pressure and cholesterol are two of the most important steps in reducing that risk, but many stroke survivors do not receive optimal treatment. The LOTUS trial is testing whether a low-dose combination pill approach — supported by a nurse-led, telehealth care model — can lower blood pressure more effectively than standard care. Participants are randomly assigned to either receive the combination treatment plus regular telehealth check-ins with a nurse team, or to continue with their usual GP-based care. The study runs for 26 weeks and also includes an optional arm for cholesterol-lowering treatment. It aims to show that nurse-supported, simplified medication approaches are practical, acceptable, and effective for stroke survivors. You may be eligible if you are 18 or older, have had a confirmed ischaemic stroke or TIA in the past 12 weeks as diagnosed by a neurologist, and need treatment to lower your blood pressure. People who have had a brain bleed, are pregnant, or have significant kidney problems are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Acronyms: GMRx2 - A single pill combination of Telmisartan/Amlodipine/Indapamide, available in Quarter (1/4) strength (10/1.25/0.625), Half (1/2) strength (20/2.5/1.25), and Standard strengths (40/5/

Acronyms: GMRx2 - A single pill combination of Telmisartan/Amlodipine/Indapamide, available in Quarter (1/4) strength (10/1.25/0.625), Half (1/2) strength (20/2.5/1.25), and Standard strengths (40/5/2.5). SPC – Single Pill Combination BP - Blood Pressure CT - Combination Therapy Study Interventions – SPC based care: At randomisation, if the participant is randomised to SPC based care, they will initially be prescribed GMRx2 ¼ if not on any pre-existing BP therapy. If already on pre-existing BP therapy, they will be prescribed an appropriate dose of GMRx2 by the investigator. During follow-up visits, if the average of two home BP measurements is above 130 mmHg SBP and/or above 80 mmHg DBP, BP-lowering therapy will be up titrated by the nurse with support from the investigator in the following order: GMRx2 – triple 1/4 (telmisartan 10 mg, amlodipine 1.25 mg, indapamide 0.625 mg) Then GMRx2 – triple 1/2 (telmisartan 20mg, amlodipine 2.5mg, indapamide 1.25mg) Then GMRx2 – standard dose (telmisartan 40mg/amlodipine 5mg/indapamide 2.5mg) Then GMRx2 – standard + telmisartan 40 mg/amlodipine 5mg CT Then GMRx2 – standard + telmisartan 40 mg/amlodipine 5mg CT + spironolactone 25mg. It is preferred that the above sequence for up-titration is adhered to. However, clinicians may choose to vary the above recommended regimen at their own discretion. Participants will take their prescribed dose once daily for 26 weeks. Participants will be instructed to return all remaining medication at each clinic visit to be counted by the research nurse or pharmacist. The Medication Accountability ARMS-7 questionnaire will be completed at 12 and 26 weeks post randomisation. Optional Cholesterol Lowering Factorial Arm: Combination Therapy of rosuvastatin/ezetimibe 10mg/10mg for patients indicated for pharmacological treatment of high LDL. The low-dose combination LDL lowering strategy to be tested here will not have up titration steps. Participants will take their prescribed dose once daily for 26 weeks. Participants will be instructed to return all remaining medication at each clinic visit to be counted by the research nurse or pharmacist. The Medication Accountability ARMS-7 questionnaire will be completed at 12 and 26-weeks post randomisation. Treatment Arms/groups: Arm 1: BP Lowering Strategy (SPC of Telmisartan/amlodipine/indapamide) Arm 2: BP Lowering Strategy (SPC of Telmisartan/amlodipine/indapamide) + Cholesterol Lowering Optional Factorial Arm (Rosuvastatin 10mg/Ezetimibe 10mg CT) Arm 3: Cholesterol Lowering Optional Factorial Arm (Rosuvastatin 10mg/Ezetimibe 10mg CT) Arm 4: Usual Care