Prevention & lipidsTrial design
CorCal Outcomes: A randomized trial using the pooled cohort equation or coronary artery calcium to select statin therapy in primary prevention patients. Study design and baseline characteristics
- randomized trial
- noninferiority design
- modified per-protocol approach
Study context
- Population
- Nondiabetic primary prevention patientsagreed to be enrolled and were randomized (2886 per arm), 75,539 screened, 5,329 completed testing for primary analysis · pooled cohort equation (PCE) 2,642 · coronary artery calcium (CAC) 2,687
- Participants
- 5,772 patients
- Planned comparison
- CAC compared to the PCE as a guide to statin initiation in preventing atherosclerotic cardiovascular disease (ASCVD) events
- CACn = 2,687
- PCEn = 2,642
No results yet. This paper sets out the design of a trial; its results are to come.
Baseline
Baseline characteristics
- Average age
- 64.3 ± 6.8 years
- Female
- 51.5%
- Baseline demographics are well-matched between arms
Study status
- Study projected to end in second quarter of 2026
- Data Safety Monitoring Board recommendations of December 9, 2024, and the Study Team's response are reported
Original publication
CorCal Outcomes: A randomized trial using the pooled cohort equation or coronary artery calcium to select statin therapy in primary prevention patients. Study design and baseline characteristics. Am Heart J. Published 7 May 2026. doi:10.1016/j.ahj.2026.107473
Summarised from the published abstract; every number is checked against it