Phase 3 Heart Disease Trial, Recruiting NCT06118281 Sponsor: Novo Nordisk A/S Condition: Heart Disease
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Phase 3 Heart Disease Trial, Recruiting

NCT06118281
Recruiting Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are 18 years old or older
  • You have been admitted to hospital with a heart attack confirmed by a procedure that looked inside your arteries (a type of X-ray of the heart's blood vessels)
  • You had a specific type of heart attack (called STEMI) where symptoms started within 12 hours before arriving at hospital, with particular abnormal readings on a heart tracing (ECG)
  • OR you had another type of heart attack (called NSTEMI) where symptoms started within 24 hours before arriving at hospital, confirmed by a blood test showing a raised level of a heart damage marker (troponin)
  • For a STEMI heart attack: you are able to receive the study treatment within 36 hours of being admitted to hospital
  • For the other type of heart attack (NSTEMI): you are able to receive the study treatment within 72 hours of being admitted to hospital
  • You also have at least one of the following in your medical history:
    • A previous heart attack
    • A previous procedure to open or bypass blocked heart arteries
    • Diabetes that is being treated with medication to lower blood sugar
    • A known moderate reduction in kidney function (confirm with trial site for exact levels)
    • A previous stroke caused by a blocked blood vessel in the brain
    • Known narrowing of the neck arteries or blocked arteries in the legs
    • Blockages in more than one heart artery (now or in the past)
    • For STEMI patients only: the current heart attack affected the front part of the heart

Who may not be able to join:

  • You received clot-dissolving medication (thrombolytics/fibrinolytics) as treatment for your current heart attack
  • You have very severe long-term heart failure (classified as the most serious category, NYHA Class IV)
  • Your blood pressure is dangerously low or your heart is not pumping well enough to keep you stable (confirm with trial site for exact definitions)
  • Your kidneys are working very poorly — specifically, kidney function is very severely reduced or you are already on kidney dialysis
  • You have a significantly elevated liver enzyme level in your blood (a marker of liver damage — confirm with trial site for exact levels)
  • You have severe liver disease, including conditions such as confusion caused by liver failure, fluid build-up in the abdomen, yellowing of the skin or eyes, previous bleeding from veins in the food pipe or stomach, or known liver scarring (cirrhosis)
  • You have had major heart surgery, non-heart surgery, or a major keyhole procedure in the past 60 days, or you are planned to have major surgery as part of your current heart attack treatment
  • You currently have signs or suspicion of an active infection, as judged by the medical team
  • You have a known hepatitis B or hepatitis C infection (whether recent or long-term)
  • You have untreated hidden (latent) tuberculosis (TB), including a previous positive TB test with TB treatment started less than 28 days before joining the trial, or you are unwilling to have TB treatment if a TB test comes back positive (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Clinical Transparency dept. 2834, Novo Nordisk A/S

Phone: (+1) 866-867-7178

Australian sites

Concord Repatriation General Hospital - Cardiology Department, Concord, New South Wales
Nepean Hospital, Kingswood, New South Wales
Liverpool Hospital, Liverpool, New South Wales
Liverpool Hospital, Liverpool, New South Wales
Prince of Wales Hospital - Sydney, Randwick, New South Wales
Illawarra Heart Health Centre, Wollongong, New South Wales
Sunshine Coast University Hospital - Clinical Research Unit, Birtinya, Queensland
Royal Brisbane and Women's Hospital, Brisbane, Queensland
The Prince Charles Hospital, Brisbane, Queensland
The Prince Charles Hospital, Brisbane, Queensland
Cairns Base Hospital, Cairns, Queensland
Townsville University Hospital, Douglas, Queensland
Gold Coast University Hospital - Cardiology Department, Southport, Queensland
Gold Coast University Hosptial, Southport, Queensland
Princess Alexandra Hospital, Woolloongabba, Queensland
Princess Alexandra Hospital, Woolloongabba, Queensland
Royal Adelaide Hospital - Cardiology Department, Adelaide, South Australia
Royal Adelaide Hospital Cardiovascular Clinical Trials, Adelaide, South Australia
Flinders Medical Centre, Bedford Park, South Australia
Lyell McEwin Hospital, Elizabeth Vale, South Australia
Lyell McEwin Hospital, Elizabeth Vale, South Australia
Northern Health, Epping, Victoria
Peninsula University Hospital - Cardiology Department, Frankston, Victoria
Adrian Costa Clinical Trials Centre, Geelong, Victoria
Austin Hospital, Heidelberg, Victoria
The Alfred - Endocrinology & Diabetes Department, South Yarra, Victoria
Sunshine Hospital - Western Centre for Health Research and Education, St Albans, Victoria
Royal Perth Hospital, Perth, Western Australia

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
25 June 2024
Est. completion
14 December 2026

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇧🇷 Brazil 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇳 China 🇨🇿 Czechia 🇩🇰 Denmark 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇮🇳 India 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇲🇾 Malaysia 🇲🇽 Mexico 🇳🇱 Netherlands 🇵🇱 Poland 🇰🇷 South Korea 🇪🇸 Spain Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

28 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Time to first occurrence of a 3-component major adverse cardiovascular event (MACE) endpoint comprising: Cardiovascular (CV) death, Non-fatal myocardial infarction (MI), Non-fatal stroke

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov