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STICH-3.0 International Trial Consortium
RECRUITINGN/ASponsored by Vastra Gotaland Region
Actively Recruiting
PhaseN/A
SponsorVastra Gotaland Region
Started2022-09-14
Est. completion2029-09-14
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05761067
Summary
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.
Eligibility
Age: 18 Years+Healthy volunteers accepted
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.
Conditions3
Coronary Artery DiseaseHeart DiseaseHeart Failure
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Actively Recruiting
PhaseN/A
SponsorVastra Gotaland Region
Started2022-09-14
Est. completion2029-09-14
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05761067