Phase 3 Heart Disease Trial, Recruiting NCT06399692 Sponsor: Weill Medical College of Cornell University Condition: Heart Disease
Printed from Voxsanity (voxsanity.com.au) — NCT06399692 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 3 Heart Disease Trial, Recruiting

NCT06399692
Recruiting Phase 3

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:

  • The person must be female.
  • The person must be at least 18 years old.
  • The person must have coronary artery disease affecting multiple blood vessels or the main artery of the heart, where the medical team has determined that either open-heart bypass surgery or a stenting procedure (to open blocked arteries) would be a reasonable treatment option.
  • The person must be able to sign a consent form and take part in all follow-up visits, including completing quality-of-life questionnaires.

Who may not be able to join:

  • The person has had a severe heart attack (a specific type called ST-elevation MI) within the past 3 days.
  • The person is currently in a life-threatening state of heart failure known as cardiogenic shock.
  • The person has had a stenting procedure (PCI) within the past year, or has ever had open-heart bypass surgery (CABG) at any point in the past.
  • A treatment plan is already in place that combines both a stenting procedure and bypass surgery.
  • Only a single blood vessel is planned to be treated (unless the blockage is only in the main heart artery).
  • The person needs any other heart surgery or heart procedure now or is expected to need one within the next 3 years.
  • The person is pregnant, or a pregnancy test taken within one week before joining the trial is positive, or the person plans to become pregnant within one year of joining.
  • The person is unable to take a specific type of blood-thinning medication (dual antiplatelet therapy) for the required period — at least 3 months for stable heart disease, or at least 6 months following a certain type of heart event involving elevated troponin levels (confirm with trial site).
  • The person is currently enrolled in another clinical trial for an experimental drug or device that has not yet reached its main study goal.
  • The person has a non-heart-related illness that means their life expectancy is less than 3 years.
  • The person has any condition — such as a cognitive disability, substance use issues, or plans to move overseas — that may make it difficult to follow the study requirements or attend follow-up visits for up to 10 years.

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 16 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: Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC, Weill Medical College of Cornell University

Phone: 212.746.1812

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
Weill Medical College of Cornell University
Registry
ClinicalTrials.gov
Start date
16 September 2024
Est. completion
15 March 2033

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Hierarchical composite of all-cause death and time-averaged change from baseline in generic quality of life using the SF-12v2

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

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Data last synced from ClinicalTrials.gov: 16 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