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Study of laroprovstat (AZD0780) to reduce heart attack, stroke and vascular complications in patients with atherosclerotic cardiovascular disease or high risk of developing it

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial 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.

  2. Step 2

    Medication 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.

  3. Step 3

    Health 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

  4. Step 4

    Regular 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 trial?

14 criteria

  • 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 trial?

15 criteria

  • 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
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Investigated drugs

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.

What is already known about the treatment

AZD0780 - A novel investigational drug currently undergoing Phase III clinical trials for treating Atherosclerotic Cardiovascular Disease (ASCVD). The medication is being studied for its potential to reduce major adverse cardiovascular events in patients with established ASCVD or those at high risk for first cardiovascular events. This experimental compound is being evaluated in a double-blind, placebo-controlled study to assess its effectiveness in preventing serious cardiovascular outcomes including cardiovascular death, myocardial infarction, ischemic stroke, and acute limb ischemia. While the specific mechanism of action and administration route are not detailed in the source data, the drug is being investigated as a preventive treatment for cardiovascular complications in at-risk populations.

Investigated diseases

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.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520519-14-00Protocol codeD7960C00015Estimated enrolment15 100 patientsSponsorAstraZeneca AB

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).