Atherosclerotic cardiovascular disease (ASCVD) is a leading cause of disease burden and healthcare costs in Australia, accounting for a significant proportion of hospitalisations and premature deaths. ASCVD includes conditions such as coronary artery disease, stroke, and peripheral arterial disease, all caused by plaque build-up in the arteries. Common health issues in Australia, including obesity, diabetes, and metabolic disorders, further increase the risk of ASCVD. 

Elevated Lipoprotein(a), or Lp(a), is another important but often overlooked factor. It is a genetically determined, independent risk marker that is not routinely tested in general practice. High Lp(a) levels are associated with greater plaque volume and arterial inflammation, which significantly raise the risk of heart attacks and strokes.

The investigational treatment is given as an injection under the skin once every 12 weeks for 60 weeks. You’ll receive the injection at the clinic during scheduled visits.

Currently, there are no approved treatments that directly lower lipoprotein(a) [Lp(a)], a genetically inherited lipid particle linked to increased risk of heart attacks and strokes. This creates a significant gap in care, especially given that atherosclerotic cardiovascular disease (ASCVD) remains one of the leading causes of death and disability in Australia.

We are seeking applications from people who:

• are aged 35 to 80
• have high lipoprotein(a) levels
• been on cholesterol-lowering medication for at least 2 weeks
• have a history of a heart attack or heart procedure
• can attend up to 9 visits and 1 phone call over 18 months

The trial will be conducted at our Sippy Downs clinic in the Sunshine Coast.

Eligible participants will be reimbursed for reasonable study-related expenses.

This trial has been reviewed and approved by an independent Human Research Ethics Committee.

What's involved?

Participants will attend regular clinic visits over an 18 month treatment period (about 1.5 years), including heart imaging scans (CCTA), safety assessments, and follow-up visits. Even if a participant stops receiving the investigational treatment, they may still be asked to complete follow-up assessments.

The investigational treatment is given as an injection under the skin once every 12 weeks for 60 weeks. You’ll receive the injection at the clinic during scheduled visits. Participants have a 50% chance of receiving a placebo in place of the investigational treatment.

Procedures:

• Physical examination and vital signs
• Electrocardiogram (ECG)
• Urine pregnancy test (if applicable)
• Urine sample collection
• Blood sample collection
• Injection of investigational treatment (every 12 weeks)
• Coronary CT Angiography (CCTA) scans

The trial lasts for approximately 18 months (just over 1.5 years).

During this time, participants will:

• Receive an injection of the investigational treatment or placebo once every 12 weeks at the clinic
• Attend regular clinic visits for health checks and heart imaging
• Be monitored for safety and effectiveness of the treatment
• Have their vital signs, lab tests, and heart health assessed throughout the study
• Be asked to stay on their usual cholesterol-lowering medications unless changes are medically necessary

Even if you stop receiving the investigational treatment, you may still be asked to attend follow-up visits to help researchers gather important health information.

Where can I find more information?

More information can be requested by contacting the recruitment team on 07 5409 8640  Alternatively, the team will be more than happy to answer any questions you may have when they call.