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Comparing the Components of Composite Endpoints for Healthcare Providers and Patients

NCT07378137 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2026-01-30

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Questionnaire

A questionnaire regarding the weights given by the patients with CAD and the medical staff for the individual components of the composite endpoint

Sponsors & Collaborators

  • Xijing Hospital

    lead OTHER

Principal Investigators

  • Ling Tao, M.D., Ph.D · Xijing Hospital

  • Chao Gao, M.D., Ph.D · Xijing Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-18
Primary Completion
2026-03-01
Completion
2026-03-01

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07378137 on ClinicalTrials.gov