STICH-3.0 International Trial Consortium
Recruiting · NCT05761067 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Percutaneous Coronary Intervention (PCI)
What this trial is about
The primary objective of the STICH 3.0 Study is to determine whether CABG is superior to PCI in terms of all-cause mortality at 5 years in patients with severe CAD and iLVSD. Individual patient data from similar national RCTs independently powered for different efficacy endpoints will be pooled, harmonized, and analyzed. The primary endpoint is all-cause mortality.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age \>18 years
- LVEF ≤40%
- Extensive coronary artery disease (typically defined as a British Cardiovascular Intervention Society jeopardy score of ≥6, on a scale from 0 to 12, with higher scores indicating greater extent of disease).
Exclusion criteria
- Decompensated heart failure 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;
- Valvular heart disease or any other cardiac conditions (e.g. LV aneurysm) indicating the need for surgical repair/replacement;
- Prohibitive bleeding risk or clinical scenario mandating avoidance of long-term dual antiplatelet therapy;
- Pregnancy;
- Circumstances likely to lead to poor treatment adherence;
- STEMI within 72 hours;
- PCI within 3 months.
Where it is running
1 location listed.
- Dep of Cardiology, Sahlgrenska University Hospital - Gothenburg, Sweden