Phase 3 Heart Disease Trial, Recruiting NCT03998319 Sponsor: University of Sydney Condition: Heart Disease
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Phase 3 Heart Disease Trial, Recruiting

NCT03998319
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:

  • Adults aged 18 or older who have had a specific type of heart attack (called a STEMI) and arrived for treatment within 6 hours of symptoms starting, with at least 20 minutes of chest pain or shortness of breath and a confirmed abnormal heart tracing (ECG) matching Australian National Heart Foundation guidelines
  • People who are willing and able to follow all study requirements, including treatments, assessments, and clinic visits
  • People who are able to read and understand the participant information form and provide written, signed, and dated consent to take part
  • People who received a metal drug-coated stent (a small tube used to open a blocked artery) during their heart procedure
  • People who agree to have heart MRI scans done 3–7 days after leaving hospital and again at 6 months

Who may not be able to join:

  • People who have previously had heart bypass surgery
  • People who have a significant narrowing (50% or more) in another part of the same heart artery being treated
  • People who have had a previous heart attack in the same area of the heart being treated
  • People who have conditions that make clot-dissolving medicines unsafe, such as a history of stroke, recent brain surgery, active internal bleeding, a brain tumour or blood vessel abnormality in the brain, uncontrolled high blood pressure, or a known bleeding disorder
  • People who have conditions that make a specific heart pressure test (using a medicine called adenosine) unsafe, such as certain heart rhythm problems, moderate to severe breathing conditions like asthma, or certain types of heart block
  • People diagnosed with cancer that has spread to other parts of the body
  • People with a serious illness, such as a severe infection, that could make it unsafe to go through the study procedures
  • People with serious medical or psychiatric (mental health) conditions that may make it difficult to follow the study plan
  • People who are pregnant, breastfeeding, or not using reliable contraception; women of childbearing age must have a negative pregnancy test within 7 days before joining; men must be surgically sterilised or use a barrier method of contraception (double if required)
  • People who have taken part in another research study in the past 30 days
  • People in the MRI part of the study who have conditions making contrast MRI scans unsafe, such as severe claustrophobia, pregnancy, a pacemaker, certain non-MRI-safe metal implants in the brain, a defibrillator, or significantly reduced kidney function (confirm with trial site)
  • People who received a specific type of blood-thinning medication (called GpIIb/IIIa inhibitors) before a certain heart pressure measurement was taken during their procedure
  • People whose blocked artery was not severe enough to require the heart procedure, or who did not have the procedure for other reasons

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 7 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: Martin Ng, MBBS (Hons), Royal Prince Alfred Hospital, Sydney, Australia

Phone: +614 3407 8507

Australian sites

Bankstown-Lidcombe Hospital, Bankstown, New South Wales
+612 9722 8486
Royal Prince Alfred Hospital, Camperdown, New South Wales
+614 3407 8507
Concord Repatriation General Hospital, Concord, New South Wales
+614 0130 1790
Northern Beaches Hospital, Frenchs Forest, New South Wales
Liverpool Hospital, Liverpool, New South Wales
(02) 8738 3051
John Hunter Hospital, New Lambton Heights, New South Wales
(02) 4921 4720
Prince of Wales Hospital, Randwick, New South Wales
(02) 9382 0770
Wollongong Hospital, Wollongong, New South Wales
Royal Adelaide Hospital, Adelaide, South Australia
(08) 7074 1796
Lyell McEwin Hospital, Elizabeth Vale, South Australia
Box Hill Hospital, Box Hill, Victoria
Jessie McPherson Private Hospital, Clayton, Victoria
Victorian Heart Hospital, Clayton, Victoria
The Northern Hospital, Epping, Victoria
Frankston Hospital, Frankston, Victoria
(03) 9748 2687
Sunshine Hospital, Saint Albans, Victoria
0435 612 868
Fiona Stanley Hospital, Murdoch, Western Australia
08 6152 6604
Royal Perth Hospital, Perth, Western Australia
(08) 9224 3290

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
Sponsor
University of Sydney
Registry
ClinicalTrials.gov
Start date
14 October 2021
Est. completion
31 December 2024

Where this trial is recruiting

🇦🇺 Australia 🇳🇿 New Zealand

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

Primary endpoints

To compare the number of participants who experience cardiovascular mortality and rehospitalisation for heart failure at 24 months in those given tenecteplase with those given placebo (Cardiac MRI cohort only); To compare MI size as a % of LV mass and intramyocardial bleeding rates in participants at 6 months post PCI in those given low dose tenecteplase with those given placebo.

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: 7 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