Comparing the Components of Composite Endpoints for Healthcare Providers and Patients

Clinical trials often employ a composite primary endpoint to increase event rates and enhance trial efficiency. However, analytic approaches to composite endpoints typically assume that the individual components are of similar importance. In practice, a treatment often has different effects on each individual endpoint, leading to uncertainty in interpreting the results of a clinical trial employing a composite primary endpoint. Some investigators have recommended using a weighted composite endpoint to address these concerns, in which individual components are valued relative to one another. However, data to inform the weighting of individual endpoints, using opinions from both medical staff and patients, remains controversial. Furthermore, prior efforts to weigh composite endpoints have assumed that patients, physicians, and clinical trialists would assign similar values to individual events. If patients value endpoints differently from trialists, this would suggest that efforts to develop weighted composite endpoints may also need to address patient preferences. In the current study, we aim to record the weighing of both patients and medical staff towards a composite endpoint frequently used in cardiovascular clinical trials. To better understand the value of each endpoint for patients and medical staff, we quantified the relative severity of each endpoint when compared to death and assessed for rating differences between the two groups. Additionally, we investigated whether endpoint weights varied by the demographic and clinical characteristics of patients and medical staff.

NCT Number	NCT07378137
Lead Sponsor	Xijing Hospital
Conditions	Coronary Artery Disease, Percutaneous Coronary Intervention
Enrollment	600 participants
Start Date	2025-08-18
Primary Completion	2026-03-01 (estimated)
Study Completion	2026-03-01 (estimated)
Updated on ClinicalTrials.gov	2026-01-30