NCT07349979Not yet recruiting
PCI With GDMT Versus GDMT Alone for Patients With Ischemic Cardiomyopathy and Reduced LVEF
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
Source: ClinicalTrials.gov · Last updated 28 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 1154 (estimated)
- First submitted
- 8 Jan 2026
- Start date
- Dec 2026
- Primary completion date
- Jan 2028
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical University
- Diseases
- Heart failure, Coronary artery disease
- NCT number
- NCT07349979
What you commit to
- Study type: Interventional
- Planned participants: 1154
- From Dec 2026 to the primary completion date, Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanjing First Hospital, Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.