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.

RATIONALE: Two methods to select statin therapy for primary prevention are the pooled cohort equation (PCE), based on traditional risk factors, and coronary artery calcium (CAC), a patient-level assessment of coronary plaque burden. How well these methods compare in reducing atherosclerotic cardiovascular disease (ASCVD) outcomes is unknown.

PRIMARY AIM: The CorCal Outcomes trial is designed to evaluate the effectiveness of CAC compared to the PCE as a guide to statin initiation in preventing ASCVD events.

DESIGN

CorCal Outcomes is a randomized trial comparing CAC to PCE to guide statin initiation in nondiabetic primary prevention patients. The study has a noninferiority design and will utilize a modified per-protocol approach that includes all who completed baseline testing and received a statin recommendation. Here we describe the study design and patient population.

ENROLLMENT: From October 30, 2019, to March 25, 2025, 75,539 patients were screened via medical record query and randomly invited to participate; 5,772 agreed to be enrolled and were randomized (2886 per arm). Of those, 5,329 completed the necessary testing to be included in the primary analysis (PCE = 2,642 [49.6%], CAC = 2,687 [50.4%]).

CHARACTERISTICS: Average age is 64.3 ± 6.8 years, and 51.5% are female. Baseline demographics are well-matched between arms. The recommendations of the Data Safety Monitoring Board of December 9, 2024, and the Study Team's response are reported.

CURRENT STATUS: Enrollment in CorCal Outcomes has resulted in well-balanced characteristics in the 2 arms used to recommend a statin. Based on study progress as of December 2024, the study is projected to end in second quarter of 2026.

TRIAL REGISTRATION: This study is registered with Clinicaltrials.gov (NCT03439267).