Coronary Artery DiseaseNCT05427370
The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial (STICH3C)
A study testing Revascularization by PCI and Revascularization by CABG in people with Coronary Artery Disease and Heart Failure Systolic, run by Sunnybrook Health Sciences Centre at 46 sites in 16 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Heart Failure Systolic
- What is being tested?
- Revascularization by PCI and Revascularization by CABG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 754 participants
- Where
- 46 sitesin 16 countries
- Study dates
- 22 Jun 2023to Dec 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
46 sites in 16 countries. Contact the study team or a site near you to ask about taking part.
46 sites in 16 countries
Canada18 sites, 16 recruiting
- Recruiting
University of Calgary; Libin Cardiovascular Institute
Calgary, Alberta, T2N 4Z6
Robert Miller
Imtiaz Ali
- Recruiting
Mackenzie Health Sciences Center
Edmonton, Alberta, T6G 2B7
Jayan Nagendran
Kevin Bainey
- Recruiting
Queen Elizabeth II Hospital
Halifax, Nova Scotia, B3H 2Y9
Kim Anderson
Douglas Hayami
- Recruiting
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Catherine Demers
Sanjit Jolly
- Recruiting
London Health Sciences Center, University Hospital
London, Ontario, N6A 5A5
David Nagpal
Michael Chu
- Recruiting
Center Hospitalier Universitaire de Montreal
Montreal, Quebec, , H2X OC1
Samer Mansour
Nicolas Noiseux
- Recruiting
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Gilbert Gosselin, 514-376-3330 ext. 3238
Jean-Lucien Rouleau
- Withdrawn
Jewish General Hospital
Montreal, Quebec, H3T 1E2
- Recruiting
Hospital Sacre-Coeur
Montreal, Quebec, H4J 1C5
Erick Schampaert
Frederic Poulin
- Withdrawn
Fraser Health; Royal Columbian Hospital
New Westminster, British Columbia, V3L3W7
- Recruiting
Southlake Regional HC
Newmarket, Ontario, L3Y 2P9
Liane Porepa
Christopher Overgard
- Recruiting
Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Marc Ruel
Derek So
- Recruiting
Institut de Cardiologie Quebec (QC) - Laval
Québec, Quebec, G1V 4G5
Dimitri Kalavrouziotis
Jean-Michel Paradis
- Recruiting
Sunnybrook Health Sciences Center
Toronto, Ontario, M4N 3M5
Stephen Fremes, MD,FRCS(C), 1-416-480-6100 ext. 66073
Dennis Ko
- Recruiting
St. Michael's
Toronto, Ontario, M5B 1W8
Akshay Bagai
Michael Kutryk
- Recruiting
Toronto General Hospital
Toronto, Ontario, M5G 2N2
Vivek Rao
Michael McDonald
- Recruiting
Providence Health
Vancouver, British Columbia, V6Z 1Y6
James Abel
Brian Clarke
- Recruiting
The University of Manitoba and St. Boniface Hospital Inc.
Winnipeg, Manitoba, R2H 2A6
Andrew Fagan
United States6 sites, 5 recruiting
- Recruiting
John Hopkins Hospital
Baltimore, Maryland, 21205
Jennifer Lawton
Jon Resar
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Rakesh Arora
Yasir Abu-Omar
- Recruiting
Cedars-Sinai
Los Angeles, California, 90048
Dominic Emerson
Raj Makkar
- Recruiting
UofL Health, Inc
Louisville, Kentucky, 40202
Naresh Solanki
Ravi Sharma
- Recruiting
Yale University
New Haven, Connecticut, 06510
Marc Pelletier
Kathryn Clark
- Withdrawn
Mayo Clinic
Rochester, Minnesota, 55905
Spain4 sites, 4 recruiting
- Recruiting
Hospital del Vinalopó
Alicante
Jose Albors Martin
Edgardo Castillo
- Recruiting
Hospital Clinic de Barcelona (ICCV)
Barcelona, L'Eixample, 08036
Jorge Alcocer
Eduard Solé
- Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120
Sergio Juan Canovas Lopez
- Recruiting
Hospital Universitario de Navarra
Pamplona, 31008
Rafael Sádaba
Brazil2 sites, 1 recruiting
- Withdrawn
Institute of Cardiology
Porto Alegre
- Recruiting
Heart Institute, Medical School of the University of Sao Paulo_INCOR
São Paulo, 05403-900
Whady Armindo Hueb
China2 sites, 2 recruiting
- Recruiting
Jilin Heart Hospital
Jilin City, Changchun, 130117
Massimo Lemma
Francesco Lavarra
- Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200031
Qiang Zhao
Yunpeng Zhu
Germany2 sites, 2 recruiting
- Recruiting
University Hospital Dusseldorf
Düsseldorf, 40225
Alexander Assmann
- Recruiting
Leipzig Heart Center
Leipzig, 04289
Michael Borger
Poland2 sites, 1 recruiting
- Recruiting
Medical University Bialystok
Bialystok, 15-089
Marek Deja
- Active, not recruiting
Medical University of Silesia
Katowice
Portugal2 sites, 2 recruiting
- Recruiting
Unidade Local de Saude Lisboa Ocidental (ULSLO)
Lisbon, 1350-410
Miguel Sousa Uva
Manuel Almeida
- Recruiting
Centro Hospitalar e Universitário Sao João
Porto, 4200-319
Adelino Leite-Moreira
Marta Ramos Tavares Silva
Croatia1 site, 1 recruiting
- Recruiting
Clinical Hospital Dubrava
Sušak, Zagreb, 10000
Igor Rudez
Davor Baric
Egypt1 site, 1 recruiting
- Recruiting
Al Nas Hospital
Cairo, Qalyubia Governorate
Mostafa M Abdrabou
India1 site, 1 recruiting
- Recruiting
G Kuppuswamy Naidu Memorial Hospital (GKNM)
Palayam, Tamil Nadu, 641037
Chandrasekar Padmanabhan
Rajpal Abhaichand
Italy1 site, 1 recruiting
- Recruiting
European Hospital, Via Portuense
Roma, RM, 00149
Ruggero De Paulis, 39 0665975224
Luca Weltert
Latvia1 site, 1 recruiting
- Recruiting
Pauls Stradins Clinical University Hospital
Riga
Peteris Stradins
Mexico1 site, 1 recruiting
- Recruiting
Instituto Mexicano del Seguro Social (IMSS)
Mexico City
Jorge Escebedo
Gabriela Borrayo
Serbia1 site, 1 recruiting
- Recruiting
Dedinje Cardiovascular Institute
Belgrade
Milan Milojevic
Goran Loncar
About this study
Official title: The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial
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).
Read more
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.
Read the detailed description
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.
- Conditions
- Coronary Artery Disease, Heart Failure Systolic
- Being tested
- Revascularization by PCI, Revascularization by CABG
- Keywords
- Left ventricular dysfunction, CABG, PCI, MACCE
- Medical subject headings
- Coronary Artery Disease, Heart Failure, Systolic, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revascularization by PCIProcedure or surgery
Contemporary, "State-of-the-art" PCI techniques will be encouraged in STICH3C, based on the most recent evidence and clinical practice guidelines recommendations. The best practices to be followed include the use of physiological and intravascular guidance, new-generation drug-eluting stents or scaffolds, rotational or orbital atherectomy for extensive calcifications, recommended bifurcation techniques, chronic total occlusion for viable segments by experienced operators, and trans-radial access.Planned temporary ventricular support is permitted by experienced operators when deemed indicated.
Revascularization by CABGProcedure or surgery
The surgical revascularization strategy will be tailored according to the individual patient's coronary anatomy, left ventricular remodeling, aortic atherosclerosis, co-morbidities, local expertise, and surgical judgement. An internal thoracic artery will be used to graft the left anterior descending in all cases. Multi-arterial grafting may be considered in patients without significant co-morbidities and with expected limited vasopressor use, or in patients without saphenous conduits. Choice of on- vs. off-pump surgery is influenced by LV size, associated valvular disease, and aortic atherosclerosis, as well as surgeon experience, but on-pump surgery is recommended routinely. The use of adjunctive intra-aortic balloon support or other cardiac support is not routinely recommended in stable patients; the intra-aortic balloon support is the first line mechanical support.
| Study group | Role | What they receive |
|---|---|---|
| Revascularization by PCI | Experimental | Revascularization will be attempted on/for significant lesions in major coronary vessels/side branches as planned by the local Heart Team, with the general recommendation of stenotic/occluded vessels with diameter >2.0 mm for PCI. The Heart Team consists of a minimum of one heart failure cardiologist, one interventional cardiologist and one cardiac surgeon. Receives: Procedure: Revascularization by PCI |
| Revascularization by CABG | Experimental | Revascularization will be attempted on/for significant lesions in major coronary vessels/side branches as planned by the local Heart Team, with the general recommendation of stenotic/occluded vessels with diameter >1.5 mm for CABG. The Heart Team consists of a minimum of one heart failure cardiologist, one interventional cardiologist and one cardiac surgeon Receives: Procedure: Revascularization by CABG |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary outcome is a Composite of all-cause mortality, stroke, spontaneous myocardial infarction, urgent repeat revascularization or heart failure readmission.
Time to event outcome measured as the time from randomization to the occurence of the first event.
Measured: Median follow-up of 5 years.
Secondary outcomes (13)
Death
Death will be reported at 30 days. Death over the entire duration of study will be reported as a time to event outcome. Death will be adjudicated as cardiovascular, non-cardiovascular and unknown.
Measured: At 30 days , 90 days and through study completion with a median follow-up of 5 years.
Myocardial Infarction (MI)
Periprocedural/perioperative MI is defined as <48 hours from revascularization. Spontaneous MI is defined as > or = 48 hours post revascularization
Measured: At 30 days and through study completion with a median follow-up of 5 years.
Number of participants with Stroke
Strokes will be classified as ischemic, hemorrhagic or uncertain.
Measured: At 30 days , 90 days and through study completion with a median follow-up of 5 years.
Repeat Revascularization (RR)
Only urgent clinically driven unplanned repeat revascularizations by either PCI or CABG count towards primary ouctome. RR will be classified according to type (CABG vs. PCI), by location (target vessel vs. target lesion vs. graft vs. other), and whether clinically vs. non-clinically driven. Stent thrombosis (ARC defined) and graft thrombosis/ occlusion will be reported.
Measured: At 30 days , 90 days and through study completion with a median follow-up of 5 years.
Hospitalizations
Hospitalizations will be defined as cardiac or non-cardiac. Hospitalizations will be reported as the number of participants with hospitalizations and as a count.
Measured: Through study completion with a median follow-up of 5 years.
Composite of death/stroke/spontaneous MI
Measured as a time-to-event.
Measured: Through study completion with a median follow-up of 5 years.
Composite of death/stroke/spontaneous MI/RR
Measured as a time-to-event.
Measured: Through study completion with a median follow-up of 5 years.
Composite of death or cardiac hospitalization
Measured as a time-to-event.
Measured: Through study completion with a median follow-up of 5 years.
Coronary composite endpoint
Coronary heart disease death, non-fatal MI, and coronary revascularization procedure. Measured as time-to-event outcome.
Measured: Through study completion with a median follow-up of 5 years.
Heart Failure endpoint
Heart Failure Event (composite of heart failure death, heart failure hospitalization or revascularization for HF). Measured as time-to-event outcome.
Measured: Through study completion with a median follow-up of 5 years.
Hierarchal Heart Failure outcome
The key hierarchal outcome of time to death and frequency of HF rehospitalizations will be tested using a win ratio
Measured: Through study completion with a median follow-up of 5 years.
Number of participants with advanced Heart failure therapies
This includes - ICD/CRT implantation,Mitral valve repair (transcatheter/surgical),Ventricular Assist Device and Heart Transplant
Measured: Through study completion with a median follow-up of 5 years.
Major Adverse Events
These will be reported as the composite and individually: new renal replacement therapy, major bleeding (Bleeding Academic Research Consortium (BARC) 3-5), major vascular complication (according to VARC-2 criteria), unplanned RR, other reoperation, surgical site complication, intubation >48 hours, cardiac arrest, advanced cardiac life support, stroke and death.
Measured: Results will be reported at 30 days and 90 days after index procedure (and 30 days after any planned staged PCI, allowed up to 90 days after randomization) as cardiac surgical hospitalizations maybe prolonged.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start22 Jun 2023
- Primary completionApr 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The STICH3C trial is a prospective, unblinded, international multi-center randomized trial of comparing revascularization by PCI vs. CABG in patients with multivessel/LM CAD and reduced LVEF.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 754 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Weill Medical College of Cornell University
- Responsible party
- Principal investigator, Stephen E. Fremes, Sunnybrook Health Sciences Centre
- Investigators
- Stephen Fremes, MD,MSc,FRCSC, Principal investigator, Sunnybrook Health Sciences Center, Toronto, CanadaMario Gaudino, MD,PhD, Principal investigator, Weill Medical College of Cornell University, USAJean L Rouleau, MD,PhD, Principal investigator, Montreal Heart Institute, QC CanadaGuillaume Maquis-Gravel, MD,MSc, Principal investigator, Montreal Heart Institute, QC Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427370
- Sponsor's protocol ID
- v.1.6; August 22, 2025
- Status last verified
- Oct 2026
- First submitted
- 8 Jun 2022
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fremes SE, Marquis-Gravel G, Gaudino MFL, Jolicoeur EM, Bedard S, Masterson Creber R, Ruel M, Vervoort D, Wijeysundera HC, Farkouh ME, Rouleau JL; STICH3C Study Investigators. STICH3C: Rationale and Study Protocol. Circ Cardiovasc Interv. 2023 Aug;16(8):e012527. doi: 10.1161/CIRCINTERVENTIONS.122.012527. Epub 2023 Aug 15.
PubMed 37582169