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NOT YET RECRUITING
NCT05534698
NA

Coronary Artery Bypass Grafts or Percutaneous Coronary Intervention for High Risk Patients

Sponsor: Danish Study Group

View on ClinicalTrials.gov

Summary

Most patients with Left Ventricular Systolic Dysfunction (LVSD) or heart failure (HF) have coronary artery disease (CAD) while some patients also have renal disease. Life-saving revascularization is underperformed in patients with LVSD or HF due to CAD, and especially if there is concomitant renal disease. We hypothesize that PCI will be non-inferior to CABG for all-cause mortality and recurrent myocardial infarction (MI), stroke or hospitalization for HF. To compare revascularization by PCI versus by CABG, we will perform a multicentre, open-label, parallel, randomized, controlled trial in patients with severe CAD who belong to defined categories of moderate-to-high risk characteristics, where guidelines acknowledge that both PCI and CABG are relevant treatment options.

Official title: Coronary Artery Bypass Grafts or Percutaneous Coronary Intervention for Revascularization in Moderate to Highs Risk Patients With Ischemic Heart Disease and Reduced Left Ventricular Ejection Fraction

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

1550

Start Date

2022-10

Completion Date

2033-02

Last Updated

2022-09-15

Healthy Volunteers

No

Interventions

PROCEDURE

PCI

Revascularization by PCI

PROCEDURE

CABG

Revascularization by CABG

Locations (1)

Rigshospitalet, University of Copenhagen

Copenhagen, Denmark