LOTUS: Low dose cOmbinations To improve stroke oUtcomeS

Background:

Ischaemic stroke is the most common form of stroke – accounting for almost 90% of the 20 million new strokes that occur in the world each year. Stroke survivors are at a high risk of having another stroke and other serious events. This risk is even higher for patients with poorly controlled high blood pressure and cholesterol levels.

While 70% of Australian stroke survivors are discharged from hospital on medications to lower their blood pressure and cholesterol, research shows that only 1 in 3 maintain a healthy blood pressure, 1 in 5 maintain healthy cholesterol levels, and just 1 in 10 manage both long-term.

This is largely because many stroke survivors find it difficult to take their medications as prescribed, and to have their medication adjusted when needed. Many stroke survivors have limited access to specialist services after they leave the hospital and follow up appointments with their GPs are often inconsistent – especially for those in rural, regional and remote communities.

Within a year of having a stroke, 20-30% of survivors stop taking their prescribed blood pressure and cholesterol lowering medications altogether.

Reduction in blood pressure can lower the risk of having another stroke by 30%, and can reduce future cardiovascular events by 10-20%. Similarly, reducing cholesterol can lower a person’s stroke risk by around 20%. This means that a treatment approach that effectively lowers both blood pressure and cholesterol levels could notably reduce the risk of future strokes and heart problems among stroke survivors.

Aim:

The LOTUS trial aims 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 post-stroke care. Eligible participants may also receive a cholesterol lowering combination medication for the period of the trial.

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.

LOTUS aims to improve stroke treatment worldwide by developing a simple, innovative, and scalable model of care.

Research Methodology:

The LOTUS trial is a randomised-controlled, multi-centre, open-label trial. The trial will be conducted in hospitals within Australia over three years, with a total target of 400 randomised participants who will each be followed up over a 26-week period (about six months).

Eligible participants will have an equal (50%) chance of being placed in either the intervention group and prescribed the blood pressure lowering triple pill, which contains 3 types of antihypertensive medications at low doses, or the usual care group. Participants in the trial who require treatment for high cholesterol will be given the option to be randomised a second time. These participants will have an equal (50%) chance of either receiving a prescription for a cholesterol lowering combination medication, or they will continue to receive usual care.

All participants in the trial will attend three in-person clinic visits at baseline (week 0), week 12, and week 26.

Interventions:

LOTUS Blood Pressure Lowering: The LOTUS intervention for blood pressure lowering is a single combination pill called GMRx2 that contains three commonly used medications: telmisartan, amlodipine, and indapamide. GMRx2 exists in three strengths:

Dose 1: telmisartan 10mg/amlodipine 1.25mg/indapamide 0.625 mg,
Dose 2: telmisartan 20mg/amlodipine 2.5mg/indapamide 1.25mg, and
Dose 3: telmisartan 40mg/amlodipine 5mg/indapamide 2.5mg.

LOTUS Cholesterol-Lowering: The LOTUS intervention for cholesterol lowering is a single combination pill that contains two commonly used medications: rosuvastatin and ezetimibe. This medication comes in one strength:

Dose: rosuvastatin 10mg/ezetimibe 10mg.

Usual Care: Participants in the usual care groups will receive the standardised care provided to patients who have had a stroke in Australia and will be decided by the treating doctor.