Comparing the Components of Composite Endpoints for Healthcare Providers and Patients

Recruiting now

Conditions studied: Coronary Artery Disease, Percutaneous Coronary Intervention

In brief

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.

Key facts

Study ID

NCT07378137

Run by

Xijing Hospital

People needed

600

Starts

2025-08-18

Expected to finish

2026-03-01

Last updated by the study team

2026-01-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with acute or chronic coronary syndrome who have undergone percutaneous coronary intervention;
• Patients who can understand the purpose of this trial and are willing to participate in the preference questionnaire.
• Healthcare providers who treat patients with coronary artery disease.

You may not qualify if…

• Aged < 18 years;
• Inability to understand the questionnaire or presence of cognitive impairment.

Where it is running

• Xijing Hospital — Xi'an, Shaanxi, China (enrolling)

Full record on ClinicalTrials.gov

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