PCI With GDMT Versus GDMT Alone for Patients With Ischemic Cardiomyopathy and Reduced LVEF (NCT07349979) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
PCI With GDMT Versus GDMT Alone for Patients With Ischemic Cardiomyopathy and Reduced LVEF
China1,154 participantsStarted 2026-12-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing PCI — a procedure to open blocked arteries — against medication management alone for people with heart failure and a reduced ejection fraction, so can you help me understand which of those two paths you'd lean toward for my specific situation, and why?
2Since this trial is listed as 'not yet recruiting,' how long do you think it might be before it opens, and is there a standard-of-care option I should be pursuing in the meantime rather than waiting?
3The trial is listed as Phase NA, which can sometimes mean it's a pragmatic or comparative effectiveness study rather than an early safety study — does that change how much is already known about the risks of PCI in patients with my level of reduced ejection fraction?
4The primary outcome being measured is major adverse cardiovascular events, or MACE — how does my personal risk of a serious cardiac event factor into whether a procedure like PCI, versus staying on optimized medications, makes more sense for me right now?
5Because my heart's pumping function is already reduced, what are the specific procedural risks of PCI that I should be aware of before considering a trial like this, and how do those risks compare to simply continuing on guideline-directed medical therapy?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Major adverse cardiovascular events (MACE)
Timeframe: From randomization to the time when the last enrolled patient reaches 12-month follow-up.
Trial details
NCT IDNCT07349979
SponsorNanjing First Hospital, Nanjing Medical University
. 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 criteria
. 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.