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Major trial pits drugs vs. surgery vs. stents for failing hearts

NCT ID NCT06566183

Disease control Sponsor: NYU Langone Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial studies 1,200 people with severe coronary artery disease and a weak heart pump (ejection fraction 40% or less). Participants are randomly assigned to receive either guideline-directed medical therapy, bypass surgery, or stenting. The study tracks survival, heart events, cognitive function, and quality of life to determine the most effective treatment strategy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Guideline-directed medical therapy, coronary artery bypass grafting, and percutaneous coronary intervention
What this could lead to
If successful, this trial could show which treatment—medication, bypass surgery, or stenting—is best for improving survival, heart function, and thinking skills in people with advanced heart disease.
What could go wrong
This trial is currently suspended, and results may not apply to all patients. The study is large but still uncertain, and all procedures carry risks like infection, bleeding, or heart complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,200 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Dec 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

55 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Left ventricular ejection fraction (LVEF) ≤ 40% within prior 6 months (any local measurement, made within the past 6 months using echocardiography, multigated acquisition (MUGA), computed tomography (CT) scanning, magnetic resonance imaging (MRI), or ventricular angiography is acceptable, provided no subsequent measurement above 40%) * Participants with multivessel CAD (defined as severe 3 vessel disease or 2 vessel disease including left anterior descending (LAD) artery disease) on coronary CT angiography (CCTA) or invasive coronary angiography * CAD amenable to either PCI or CABG as determined by the local heart team * Participant is willing to comply with all aspects of the protocol, including adherence to the assigned strategy, medical therapy and follow-up visits * Participant is able and willing to give written informed consent Exclusion Criteria: * Decompensated heart failure or cardiogenic shock in the past 48 hours prior to randomization * Concomitant significant valvular heart disease requiring surgery * Prior cardiac surgery * Dementia with loss of capacity to consent (clinically evident or previously diagnosed) * Stroke within the previous 6 months or spontaneous intracranial hemorrhage at any time * History of noncompliance with medical therapy * Life expectancy less than the duration of the trial due to non-cardiovascular comorbidity * Pregnancy (known to be pregnant; to be confirmed before randomization, if applicable)

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Conditions

The condition(s) this trial relates to.

Cognitive Dysfunction coronary artery disorder heart failure systolic heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cognitive impairment Coronary artery disease Heart failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • International Study Site

    International Study Site, Brazil

  • International Study Site

    International Study Site, India

  • International Study Site

    International Study Site, Mexico

  • International Study Site

    International Study Site, Poland

  • International Study Site

    International Study Site, South Korea

  • NYU Langone Health

    New York, New York, 10016, United States

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