Comparison of Efficacy and Safety of High-Intensity Statin and Ezetimibe Combination Versus Standard Care in Asymptomatic Patients With Presence of Coronary Artery Calcium (DECISION-CAL)

What this Trial Is About

This research aims to compare the safety and effectiveness of an aggressive treatment combining high-intensity statin and ezetimibe versus the current standard lipid-lowering treatment in adults who have no symptoms but show coronary artery calcification. It focuses on preventing heart-related events in people without known cardiovascular disease but with significant coronary calcium, a sign of early artery disease. This phase 4 trial addresses the gap in evidence for primary prevention using combined aggressive lipid-lowering therapy. Participants are randomly assigned to one of two groups. One group receives a high-intensity statin (rosuvastatin 20 mg) plus ezetimibe 10 mg regardless of age, diabetes status, or risk score. The other group follows the current guideline-based therapy, which varies by age and diabetes status: moderate-intensity statin (rosuvastatin 5 mg) for patients over 75 or with diabetes, and statin use guided by a cardiovascular risk score for others. Treatments are taken over a median follow-up of up to 4.5 years. During the study, participants are monitored for major cardiovascular events such as heart attacks, strokes, and deaths, as well as other outcomes like hospitalizations and bleeding events. Researchers assess changes in coronary calcium progression, LDL cholesterol levels, and potential side effects including muscle or liver issues. The study includes regular evaluations over several years, with a focus on long-term safety and efficacy of the treatment approaches.

High-intensity Statin and Ezetimibe Therapy for Asymptomatic Patients With Positive Coronary Calcium