PCI With GDMT Versus GDMT Alone for Patients With Ischemic Cardiomyopathy and Reduced LVEF

Starting soon · Not applicable

Conditions studied: Heart Failure With Reduced Ejection Fraction, Coronary Artery Disease, Stable GDMT

In brief

To evaluate whether percutaneous coronary intervention (PCI) with contemporary drug-eluting stents (DES) combined with guideline-directed medical therapy (GDMT), compared to GDMT alone, reduces the time to first occurrence of major adverse cardiovascular events (MACE) during a median follow-up of at least 24 months, measured at the time the last enrolled patient reaches 12 months, in patients with ischemic cardiomyopathy and left-ventricular ejection fraction (LVEF) ≤40%. MACE is a composite of cardiovascular \[CV\] death, myocardial infarction (MI), heart failure (HF) related rehospitalization, heart transplantation, requirement for durable left ventricular assist device \[LVAD\] implantation, or worsening heart failure treated as an out-patient requiring treatment with intravenous medications.

Key facts

Study ID: NCT07349979
Run by: Nanjing First Hospital, Nanjing Medical University
People needed: 1154
Starts: 2026-12-30
Expected to finish: 2028-01-30
Last updated by the study team: 2026-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age ≥18 years at screening.
Documented LVEF ≤40% assessed by quantitative transthoracic echocardiography confirmed at the core laboratory within 90 days prior to randomization.
Symptomatic heart failure (NYHA Functional Class II, III, or ambulatory Class IVa) or hospitalization for heart failure within the prior 12 months or NT-proBNP ≥600 pg/mL.
Angiographically proven CAD with at least one lesion with 1) a visually estimated diameter stenosis (DS) of ≥90% or 2) chronic total occlusion with a high likelihood (>80%) of PCI success, or 3) a visually estimated DS of <90%, or 4) a ≥50% left main stenosis, with conditions 3) and 4) both requiring a QFR ≤0.80, and all planned PCI lesions considered amenable to PCI with DES by an interventional cardiologist.
On stable GDMT for at least 4 weeks prior to randomization under the advisor's assessment at each site.
The subject, or their legal guardian, has a clear understanding of the trial's design and procedures, provide written informed consent, and is able to comply with all follow-up procedures.

You may not qualify if…

Class III or IV angina requiring revascularization.
Any unplanned hospitalization within 30 days.
Any PCI within 12 months.
Any prior CABG.
Cardiogenic shock or end-stage heart failure (NYHA class IVb - unable to ambulate)
Non-cardiac life expectancy <1 year at screening (e.g., malignancy, advanced liver disease).
Coronary anatomy requiring surgical revascularization by local heart team determination.
Coronary anatomy unsuitable for PCI.
HF due to specific cardiomyopathies, including restrictive/infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, or hypertrophic obstructive cardiomyopathy (HOCM).
Severe stenosis or regurgitation of any heart valve.
Contraindication to dual antiplatelet therapy or iodinated contrast.
Pregnancy, lactation, or women of childbearing potential not using effective contraception. A negative urine pregnancy test is required within 7 days prior to randomization for women of childbearing potential.
Participation in another interventional trial that may interfere with the PCI and GDMT as specified in this protocol.
Any other circumstances that the investigator deems inappropriate for participation, including but not limited to conditions that may jeopardize patient safety, confound data interpretation, or patients unlikely to comply with study procedures.

Where it is running

Nanjing First Hospital, Nanjing Medical University — Nanjing, Jiangsu, China

Full record on ClinicalTrials.gov

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