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

NCT05427370 · Sunnybrook Health Sciences Centre
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Official title
The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial
About this study
The evidence comparing PCI and CABG with medical therapy in patients with iLVSD has been the subject of multiple systematic reviews/meta-analyses of observational studies with inconsistent results. There is a current lack of evidence from properly powered randomized trials comparing contemporary state-of-the-art PCI vs. CABG to guide the clinical management in the vulnerable population of patients with iLVSD. Understanding the relative impact of both revascularization strategies on clinical outcomes in this prevalent population would have important clinical implications. The overarching aim of the STICH3C trial is to compare the clinical efficacy and safety of contemporary PCI and CABG to treat patients with multivessel/left main (LM) CAD and iLVSD. Participants will be allocated in a 1:1 ratio to either study arm using permuted block randomization stratified for study center and acute coronary syndrome (ACS) presentation through a centrally controlled, automated, web system. Eligible patients who provide informed consent can be enrolled. It is expected that initial revascularization will take place within 2 weeks of randomization. Staged PCI is expected to take place within 90 days of randomization. The recruitment will occur over 3 years, with a total study duration of 7 years, and a median duration of follow-up of 5 years.
Eligibility criteria
Inclusion Criteria: 1. Age \>18 years; 2. LVEF ≤40% quantified by either echocardiography, SPECT ventriculography, or magnetic resonance within 2 months of randomization; 3. 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; 4. 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; 5. Signed informed consent. Exclusion Criteria: 1. 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; 2. Recent (\<4 weeks) ST-elevation MI; 3. Concomitant severe valvular disease or other condition such as left ventricular aneurysm requiring surgical repair or replacement; 4. Planned major concomitant surgical procedures (LAAO and AF ablation surgical procedures permitted); 5. Prior PCI within the past 12 months (to reduce restenosis events from prior PCIs contributing to the primary outcome); 6. Prior cardiac surgery; 7. Prohibitive bleeding risk mandating avoidance of dual antiplatelet therapy; 8. Circumstances likely to lead to poor treatment adherence; 9. Severe end-organ dysfunction (such as dialysis, liver failure, respiratory failure, cancer) that reduces life expectancy to less than 5 years; 10. Current pregnancy; 11. Patient not amenable to both CABG or PCI according to the Heart Team; 12. Takotsubo/Takotsubo Cardiomyopathy/Broken Heart Syndrome.
Study design
Enrollment target: 754 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2023-06-22
Estimated completion: 2029-12
Last updated: 2026-04-28
Interventions
Procedure: Revascularization by PCIProcedure: Revascularization by CABG
Primary outcomes
  • The Primary outcome is a Composite of all-cause mortality, stroke, spontaneous myocardial infarction, urgent repeat revascularization or heart failure readmission. (Median follow-up of 5 years.)
Sponsor
Sunnybrook Health Sciences Centre · other
With: Canadian Institutes of Health Research (CIHR), Weill Medical College of Cornell University
Contacts & investigators
ContactStephen Fremes, MD,MSc,FRCSC · contact · stephen.fremes@sunnybrook.ca · 416-480-6100
ContactReena Karkhanis, MBBS,DA,MSc · contact · reena.karkhanis@sunnybrook.ca · 416-480-6100
InvestigatorStephen Fremes, MD,MSc,FRCSC · principal_investigator, Sunnybrook Health Sciences Center, Toronto, Canada
InvestigatorMario Gaudino, MD,PhD · principal_investigator, Weill Medical College of Cornell University, USA
InvestigatorJean L Rouleau, MD,PhD · principal_investigator, Montreal Heart Institute, QC Canada
All locations (43)
Cedars-SinaiRecruiting
Los Angeles, California, United States
Yale UniversityRecruiting
New Haven, Connecticut, United States
UofL Health, IncRecruiting
Louisville, Kentucky, United States
John Hopkins HospitalRecruiting
Baltimore, Maryland, United States
Mayo ClinicWithdrawn
Rochester, Minnesota, United States
University Hospitals Cleveland Medical CenterRecruiting
Cleveland, Ohio, United States
Medical University of ViennaActive Not Recruiting
Vienna, Austria
Heart Institute, Medical School of the University of Sao Paulo_INCORRecruiting
São Paulo, Brazil
University of Calgary; Libin Cardiovascular InstituteRecruiting
Calgary, Alberta, Canada
Mackenzie Health Sciences CenterRecruiting
Edmonton, Alberta, Canada
Fraser Health; Royal Columbian HospitalWithdrawn
New Westminster, British Columbia, Canada
Providence HealthRecruiting
Vancouver, British Columbia, Canada
The University of Manitoba and St. Boniface Hospital Inc.Recruiting
Winnipeg, Manitoba, Canada
Queen Elizabeth II HospitalRecruiting
Halifax, Nova Scotia, Canada
Hamilton General HospitalRecruiting
Hamilton, Ontario, Canada
London Health Sciences Center, University HospitalRecruiting
London, Ontario, Canada
Southlake Regional HCRecruiting
Newmarket, Ontario, Canada
Ottawa Heart InstituteRecruiting
Ottawa, Ontario, Canada
Sunnybrook Health Sciences CenterRecruiting
Toronto, Ontario, Canada
St. Michael'sRecruiting
Toronto, Ontario, Canada
Toronto General HospitalRecruiting
Toronto, Ontario, Canada
Center Hospitalier Universitaire de MontrealRecruiting
Montreal, Quebec, Canada
Montreal Heart InstituteRecruiting
Montreal, Quebec, Canada
Hospital Sacre-CoeurRecruiting
Montreal, Quebec, Canada
Institut de Cardiologie Quebec (QC) - LavalRecruiting
Québec, Quebec, Canada
Jilin Heart HospitalRecruiting
Jilin City, Changchun, China
Ruijin Hospital, Shanghai Jiao Tong University School of MedicineRecruiting
Shanghai, China
Clinical Hospital DubravaRecruiting
Sušak, Zagreb, Croatia
Al Nas HospitalRecruiting
Cairo, Qalyubia Governorate, Egypt
University Hospital DusseldorfRecruiting
Düsseldorf, Germany
Leipzig Heart CenterRecruiting
Leipzig, Germany
G Kuppuswamy Naidu Memorial Hospital (GKNM)Recruiting
Palayam, Tamil Nadu, India
European Hospital, Via PortuenseRecruiting
Roma, RM, Italy
Instituto Mexicano del Seguro Social (IMSS)Recruiting
Mexico City, Mexico
Medical University BialystokRecruiting
Bialystok, Poland
Medical University of SilesiaActive Not Recruiting
Katowice, Poland
Unidade Local de Saude Lisboa Ocidental (ULSLO)Recruiting
Lisbon, Portugal
Centro Hospitalar e Universitário Sao JoãoRecruiting
Porto, Portugal
Dedinje Cardiovascular InstituteRecruiting
Belgrade, Serbia
Hospital Clinic de Barcelona (ICCV)Recruiting
Barcelona, L'Eixample, Spain
Hospital Clínico Universitario Virgen de la ArrixacaRecruiting
El Palmar, Murcia, Spain
Hospital del VinalopóRecruiting
Alicante, Spain
Hospital Universitario de NavarraRecruiting
Pamplona, Spain
The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial (STICH3C) · TrialPath