The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial (STICH3C)

Recruiting now · Not applicable

Conditions studied: Coronary Artery Disease, Heart Failure Systolic

In brief

The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy (STICH3C) trial is a prospective, unblinded, international multi-center randomized trial of 754 subjects enrolled in approximately 45 centers comparing revascularization by percutaneous coronary intervention (PCI) vs. coronary artery bypass grafting (CABG) in patients with multivessel/left main (LM) coronary artery disease (CAD) and reduced left ventricular ejection fraction (LVEF). The primary objective is to determine whether CABG compared to PCI is associated with a reduction in all-cause death, stroke, spontaneous myocardial infarction (MI), urgent repeat revascularization (RR), or heart failure (HF) readmission over a median follow-up of 5 years in patients with multivessel/LM CAD and ischemic left ventricular dysfunction (iLVSD). Eligible patients are considered by the local Heart Team appropriate and amenable for non-emergent revascularization by both modes of revascularization. The secondary objectives are to describe the early risks of both procedures, and a comprehensive set of patient-reported outcomes longitudinally.

Key facts

Study ID

NCT05427370

Run by

Sunnybrook Health Sciences Centre

People needed

754

Starts

2023-06-22

Expected to finish

2029-12-01

Last updated by the study team

2026-04-28

Who can join

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

You may qualify if…

• Age >18 years;
• LVEF ≤40% quantified by either echocardiography, SPECT ventriculography, or magnetic resonance within 2 months of randomization;
• Prognostically important multivessel CAD (triple vessel CAD or double vessel disease including the left anterior descending (LAD) or LM). Significant coronary stenosis is defined as ≥ 70% based on coronary angiography, and/or fractional flow reserve (FFR) ≤0.80 or instantaneous wave-free ratio (iFR) ≤0.89. For LM disease, significant coronary stenosis is defined as >50% based on coronary angiography, intravascular ultrasound (IVUS) minimal luminal area (MLA) ≤6.0 mm2 (<4.5 mm2 Asian descent), or equivalent optical coherence tomography (OCT) measurements;
• The institutional Heart Team agrees that guideline-directed medical therapy (GDMT) has been initiated for ≥1 month in prevalent and newly diagnosed cases. In patients hospitalized with newly diagnosed iLVSD (with or without acute coronary syndrome (ACS)) requiring revascularization before discharge, GDMT needs to be initiated, when possible in-hospital before randomization, with the expectation that it will be titrated to maximally tolerated doses after revascularization;
• Signed informed consent.

You may not qualify if…

• Decompensated HF requiring inotropic/adrenergic support, invasive or non-invasive ventilation or intra-aortic balloon pump/ventricular assist device therapy less than 48 hours prior to randomization;
• Recent (<4 weeks) ST-elevation MI;
• Concomitant severe valvular disease or other condition such as left ventricular aneurysm requiring surgical repair or replacement;
• Planned major concomitant surgical procedures (LAAO and AF ablation surgical procedures permitted);
• Prior PCI within the past 12 months (to reduce restenosis events from prior PCIs contributing to the primary outcome);
• Prior cardiac surgery;
• Prohibitive bleeding risk mandating avoidance of dual antiplatelet therapy;
• Circumstances likely to lead to poor treatment adherence;
• Severe end-organ dysfunction (such as dialysis, liver failure, respiratory failure, cancer) that reduces life expectancy to less than 5 years;
• Current pregnancy;
• Patient not amenable to both CABG or PCI according to the Heart Team;
• Takotsubo/Takotsubo Cardiomyopathy/Broken Heart Syndrome.

Where it is running

• Hospital Universitario de Navarra — Pamplona, Spain (enrolling)
• Yale University — New Haven, Connecticut, United States (enrolling)
• UofL Health, Inc — Louisville, Kentucky, United States (enrolling)
• John Hopkins Hospital — Baltimore, Maryland, United States (enrolling)
• Hospital Clinic de Barcelona (ICCV) — Barcelona, L'Eixample, Spain (enrolling)
• Hospital Clínico Universitario Virgen de la Arrixaca — El Palmar, Murcia, Spain (enrolling)
• Hospital del Vinalopó — Alicante, Spain (enrolling)
• Cedars-Sinai — Los Angeles, California, United States (enrolling)
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (enrolling)
• Heart Institute, Medical School of the University of Sao Paulo_INCOR — São Paulo, Brazil (enrolling)
• University of Calgary; Libin Cardiovascular Institute — Calgary, Alberta, Canada (enrolling)
• Mackenzie Health Sciences Center — Edmonton, Alberta, Canada (enrolling)
• Providence Health — Vancouver, British Columbia, Canada (enrolling)
• The University of Manitoba and St. Boniface Hospital Inc. — Winnipeg, Manitoba, Canada (enrolling)
• Queen Elizabeth II Hospital — Halifax, Nova Scotia, Canada (enrolling)
• Hamilton General Hospital — Hamilton, Ontario, Canada (enrolling)
• London Health Sciences Center, University Hospital — London, Ontario, Canada (enrolling)
• Southlake Regional HC — Newmarket, Ontario, Canada (enrolling)
• Ottawa Heart Institute — Ottawa, Ontario, Canada (enrolling)
• Sunnybrook Health Sciences Center — Toronto, Ontario, Canada (enrolling)
• St. Michael's — Toronto, Ontario, Canada (enrolling)
• Toronto General Hospital — Toronto, Ontario, Canada (enrolling)
• Center Hospitalier Universitaire de Montreal — Montreal, Quebec, Canada (enrolling)
• Montreal Heart Institute — Montreal, Quebec, Canada (enrolling)
• Hospital Sacre-Coeur — Montreal, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

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