Ignite Creation Date:
2024-05-06 @ 5:46 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05427370
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2022-06-08
Brief Title:
The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial STICH3C
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 centers comparing revascularization by percutaneous coronary intervention PCI vs coronary artery bypass grafting CABG in patients with multivesselleft 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 multivesselLM 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
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 multivesselLM 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
Detailed Description:
The evidence comparing PCI and CABG with medical therapy in patients with iLVSD has been the subject of multiple systematic reviewsmeta-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 multivesselleft main LM CAD and iLVSD
Participants will be allocated in a 11 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
The overarching aim of the STICH3C trial is to compare the clinical efficacy and safety of contemporary PCI and CABG to treat patients with multivesselleft main LM CAD and iLVSD
Participants will be allocated in a 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None