Study of laroprovstat (AZD0780) to reduce heart attack, stroke and vascular complications in patients with atherosclerotic cardiovascular disease or high risk of developing it
This study focuses on patients with Atherosclerotic Cardiovascular Disease (a condition where arteries become hardened and narrowed due to the buildup of plaque) or those at high risk of developing it. The research evaluates a new medication called AZD0780 (laroprovstat) given as film-coated tablets taken by mouth, compared to a placebo.
The purpose of this research is to determine if AZD0780 can reduce the risk of serious cardiovascular events such as heart attacks, strokes, and problems with blood flow to the legs in people with cardiovascular disease. The medication will be tested in addition to patients’ regular cholesterol-lowering treatments.
During the study, participants will receive either AZD0780 or a placebo for up to 54 months. The study team will monitor participants for any cardiovascular events, including heart-related death, heart attacks, strokes, severe leg circulation problems, and emergency procedures to restore blood flow. Throughout the study, participants will continue their usual heart medications, including their regular cholesterol-lowering treatments.
1Initial assignment
You will be randomly assigned to one of two groups: one receiving AZD0780 and the other receiving a placebo (inactive tablet).
Both medications will be taken orally in the form of film-coated tablets.
Neither you nor your doctor will know which group you are in during the study.
2Medication period
You will continue taking your regular heart medications, including your current lipid-lowering medications (medications that help control cholesterol levels).
The study medication (either AZD0780 or placebo) will be added to your current treatment.
The study will continue until October 2029.
3Health monitoring
Your health will be monitored for serious heart and blood vessel-related events, including:
– Heart-related death
– Heart attack
– Stroke
– Severe leg circulation problems
– Emergency procedures to restore blood flow
– Major amputations due to blood vessel problems
4Regular assessments
Your doctor will track your overall health status throughout the study period.
The study team will monitor how the treatment affects your risk of serious heart and blood vessel problems.
Regular check-ups will be scheduled to evaluate your health and monitor any changes.
Who Can Join the Study?
Must be at least 18 years old and have one of these conditions:
History of heart problems in the past 1-12 months
Stroke due to blocked arteries in the past 1-12 months
Surgery for leg artery disease
Must have cholesterol levels (LDL-C) of at least 60 mg/dL
If cholesterol (LDL-C) is 75 mg/dL or higher, must also have at least one of these:
Type 2 diabetes requiring treatment
Age 65 or older
Previous leg amputation due to blood vessel disease
Kidney disease (not end-stage)
OR must meet these alternative criteria:
Men aged 50 or older, or women aged 55 or older
Cholesterol (LDL-C) of at least 100 mg/dL
Evidence of blood vessel disease or high-risk diabetes with organ damage
Must be taking cholesterol-lowering medications (statins) at the highest dose you can tolerate, with some exceptions:
Can take lower doses if unable to tolerate higher doses
Can participate without statins if you’ve had side effects from at least 2 different statins
Must be on a stable dose of cholesterol medications for at least 28 days before screening
Who Cannot Join the Study?
History of hemorrhagic stroke (bleeding in the brain)
Severe liver disease or abnormal liver function tests
Active, significant bleeding disorder or recent major bleeding event within past 6 months
Planned major surgery during the study period
Currently participating in another clinical research study
Uncontrolled high blood pressure (systolic BP ≥180 mmHg or diastolic BP ≥100 mmHg)
Known severe kidney disease requiring dialysis
Life expectancy less than 2 years due to non-cardiovascular conditions
History of drug or alcohol abuse within the past year
Pregnant women or women planning pregnancy during the study period
Known allergic reaction to similar medications
Unable to provide informed consent
Mental conditions that could interfere with study participation
History of non-compliance with medical treatments
Any condition that, in the investigator’s opinion, makes the patient unsuitable for the study
Want to learn more about this study or check if you can participate? Contact us.
Trial status
Country
Status
Recruitment Start
Bulgaria
Recruiting
01.09.2025
Czechia
Recruiting
01.09.2025
Denmark
Recruiting
01.09.2025
France
Recruiting
01.09.2025
Germany
Recruiting
01.09.2025
Greece
Recruiting
01.09.2025
Hungary
Recruiting
01.09.2025
Italy
Recruiting
01.09.2025
Poland
Recruiting
01.09.2025
Romania
Recruiting
01.09.2025
Slovakia
Recruiting
01.09.2025
Spain
Recruiting
01.09.2025
Sweden
Recruiting
01.09.2025
Trial locations
AZD0780 is an investigational medication being studied to reduce the risk of major cardiovascular events in patients who either have established cardiovascular disease or are at high risk for their first cardiovascular event. This medication is being tested to see if it can help prevent serious complications like heart attacks, strokes, and other problems related to blood flow in the arteries.
Atherosclerotic Cardiovascular Disease – A chronic condition where fatty deposits (plaques) build up inside the arteries, causing them to narrow and harden over time. These plaques consist of fat, cholesterol, calcium, and other substances found in the blood. The disease develops gradually over many years as the inner walls of arteries become lined with these fatty materials. As arteries become narrower, blood flow to various parts of the body becomes restricted. This condition can affect arteries throughout the body, including those supplying blood to the heart, brain, arms, legs, and other vital organs. The disease can progress silently for years before causing noticeable symptoms.
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Bulgaria 
Czechia 
Denmark 
France 
Germany 
Greece 
Hungary 
Italy 
Poland 
Romania 
Slovakia 
Spain 
Sweden 
