Status:
RECRUITING
The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial (STICH3C)
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Weill Medical College of Cornell University
Conditions:
Coronary Artery Disease
Heart Failure Systolic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
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. Th...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
754 Patients enrolled
Trial Details
Trial ID
NCT05427370
Start Date
June 22 2023
End Date
December 1 2029
Last Update
November 4 2025
Active Locations (39)
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1
Cedars-Sinai
Los Angeles, California, United States, 90048
2
Yale University
New Haven, Connecticut, United States, 06510
3
UofL Health, Inc
Louisville, Kentucky, United States, 40202
4
John Hopkins Hospital
Baltimore, Maryland, United States, 21205