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

StatusRecruiting
PhaseNot applicable
Started

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Record History

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  1. Trial sites expanded: 43 → 46 locations
  2. Study sites: 43 to 44
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 10 of 13 entries
    • Publications: details revised at 1 of 1 entry
  3. Trial sites expanded: 40 → 43 locationsv25
  4. Study sites: 39 to 40v24
  5. Re-verified, no change to tracked fieldsv23
Show 21 earlier versionsHide 21 earlier versions
  1. Site details revised at 1 of 39 sitesv22
  2. Study sites: 35 to 39v21
  3. Study sites: 37 to 35v20
  4. Study sites: 36 to 37v19
  5. Study sites: 33 to 36
    • Eligibility criteria shortened, about 2 words
    v18
  6. Study sites: 32 to 33v17
  7. Study sites: 30 to 32v16
  8. Study sites: 26 to 30v15
  9. Re-verified, no change to tracked fieldsv14
  10. Study sites: 23 to 26v13
  11. Study sites: 19 to 23v12
  12. Study sites: 14 to 19
    • Study title expanded, about 1 word
    v11
  13. Study sites: 11 to 14v10
  14. Study sites: 9 to 11
    • Eligibility criteria expanded, about 4 words
    v9
  15. Study sites: 4 to 9v8
  16. Study sites: 1 to 4v7
  17. Start date changed from estimate of Jun 2023 to Jun 22, 2023v6
  18. Start date: May 2023 to Jun 2023v5
  19. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Dec 2022 to May 2023
    • Study sites: 0 to 1
    v4
  20. Start date: Jul 2022 to Dec 2022v3
  21. Start date: Jun 2022 to Jul 2022
    • Secondary endpoints: details revised at 1 of 13 entries
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05427370
Lead Sponsor Sunnybrook Health Sciences Centre
Collaborators: Canadian Institutes of Health Research (CIHR), Weill Medical College of Cornell University
Conditions
(from sponsor)		 Coronary Artery Disease, Heart Failure Systolic
Related terms Coronary Artery Disease, Heart Failure, Systolic, Ventricular Dysfunction, Left
Enrollment 754 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov