Clinical Trial

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

Study acronym: PCI-GULF
Not Yet Recruiting
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Summary
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.
Protocol Amendment History 2 changes
critical Primary endpoint(s) modified 2026-05-29
notable Enrollment increased: 654 -> 1154 participants 2026-05-29
Trial Details
NCT Number NCT07349979
Lead Sponsor Nanjing First Hospital, Nanjing Medical University
Conditions Heart Failure With Reduced Ejection Fraction, Coronary Artery Disease, Stable GDMT
Enrollment 1,154 participants
Start Date 2026-12-30
Primary Completion 2028-01-30 (estimated)
Study Completion 2028-01-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-28