The AZURE Study

What is this study about?

Heart and vascular disease (also called ASCVD) occurs when fatty deposits (plaque) build up inside your blood vessels. This can reduce blood flow to important organs such as the heart and brain, which over time can lead to serious, life-threatening problems.

This study focuses on adults who already have this disease or are at high risk of developing it, even though they are taking medicine to lower their “bad cholesterol.”

Who is this study for?

This study is for people with high levels of “bad cholesterol” (LDL) who either have heart or vascular disease or are at high risk of developing it, even with their current treatment.

There are two different groups of people who may take part:

1. Group A: Adults with existing heart/vascular disease.
   This includes people who have had a heart attack, stroke, or a procedure to open blocked blood vessels (such as stent or bypass). These individuals’ cholesterol levels are still higher than recommended, despite taking cholesterol-lowering medicine.

2. Group B: Adults at high risk of a heart/vascular event (but no previous event).
   This includes people who have not had a heart/vascular event, but who have other medical factors that increase their risk. This may include diabetes, kidney disease, smoking, or tests showing plaque in their arteries. Their cholesterol remains high even with treatment.

What does “high risk” mean in this case?

A person may be considered at high risk of developing heart/vascular disease if they have one or more of the following:

• Diabetes

• High blood pressure

• High cholesterol

• Kidney disease (reduced kidney function)

• Obesity

• Plaque in the arteries seen on medical imaging

• A history of smoking
  
  

Doctors use international cardiovascular guidelines to determine whether someone has a moderate or high risk of heart problems.

Why is this study important?

For some people, current cholesterol-lowering medications are not enough to reduce their “bad cholesterol” (LDL).
This study is investigating whether adding the new study treatment to a person’s current therapy can help further reduce “bad cholesterol” (LDL) and better protect the heart and blood vessels from future problems.

What is the potential treatment?

All participants will continue taking their current cholesterol-lowering treatment during the study.

In the study, you will be randomly assigned (like flipping a coin) to receive either:

• The study medication, which targets “bad cholesterol” differently than traditional medications, OR

• A placebo, which looks like the study medication but has no active ingredient. This allows researchers to compare results fairly.
  
  

In addition, you will continue taking your usual cholesterol-lowering medicine (such as statins) as prescribed.

This is a double-blind study, meaning neither you nor your study doctor will know which group you are in. This helps ensure unbiased results.

What are the benefits of participating?

• You will receive consistent study-related care and health monitoring from experienced doctors.

• All study visits, tests, and medications are provided at no cost to you.

• Travel expenses may be reimbursed.

• You will help contribute to research that could improve future treatment for heart and vascular disease.

• Your participation may help advance progress in preventing heart disease for future generations.
  
  

Taking part may help doctors determine whether this new treatment can better protect against heart attacks and strokes.
Participation is completely voluntary — you can stop at any time, for any reason.

Tests and procedures

If you participate, you can expect:

• A physical exam and review of your medical history

• Blood tests to check cholesterol, liver, kidney, and blood sugar levels

• Vital signs such as blood pressure, pulse, weight, etc.

• A review of your current medications

• Heart-related assessments (if needed)

• Questionnaires about your general health and well-being