Stenting plus medicines versus medicines alone for weak heart from blocked arteries
Compares stent procedures plus medicines with medicines alone in adults with ischemic cardiomyopathy.
Plain-language title generated from the registry record
Registry title: PCI With GDMT Versus GDMT Alone for Patients With Ischemic Cardiomyopathy and Reduced LVEF
Key facts
- Where
- Nanjing, ChinaSee the site
Where in China
- Nanjing First Hospital, Nanjing Medical UniversityNanjing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Nanjing First Hospital, Nanjing Medical University
- Trial code
- NCT07349979
- Record updated
- 28 May 2026
- Original description
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.Read full original descriptionShow less
Percutaneous Coronary Intervention With Guideline-Directed Medical Therapy Versus Guideline-Directed Medical Therapy Alone for Patients With Ischemic Cardiomyopathy and Reduced Left Ventricular Ejection Fraction: A Randomized, Controlled, Open-Label, Multicenter PCI-GULF Trial
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.
Inclusion: 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.
Exclusion: Any prior CABG; 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; Class III or IV angina requiring revascularization; 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; Severe stenosis or regurgitation of any heart valve; 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; Any unplanned hospitalization within 30 days; Any PCI within 12 months; Coronary anatomy unsuitable for PCI; HF due to specific cardiomyopathies, including restrictive/infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, or hypertrophic obstructive cardiomyopathy (HOCM); Participation in another interventional trial that may interfere with the PCI and GDMT as specified in this protocol.