Comparing the Components of Composite Endpoints for Healthcare Providers and Patients

NCT07378137 | Recruiting DMC

• 1 other identifier: REC-CHARTENDS
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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

Coronary Artery Disease; Percutaneous Coronary Intervention

Keywords

coronary artery disease; composite endpoints

Outcome Measures

Primary Outcomes (8)

• Relative weight of myocardial infarction to death

  Before discharge

• Relative weight of stroke to death

  Before discharge

• Relative weight of cardiopulmonary resuscitation to death

  Before discharge

• Relative weight of procedural complications to death

  Before discharge

• Relative weight of major bleeding events to death

  Before discharge

• Relative weight of acute kidney injury to death

  Before discharge

• Relative weight of revascularization to death

  Before discharge

• Relative weight of rehospitalization to death

  Before discharge

Study Arms (1)

Subjects

Medical staff and patients with CAD

Other: Questionnaire

Interventions

Questionnaire OTHER

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

Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthcare providers and patients with CAD

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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ling Tao, M.D., Ph.D

  Xijing Hospital

  STUDY CHAIR

• Chao Gao, M.D., Ph.D

  Xijing Hospital

  STUDY CHAIR

Central Study Contacts

Ruining Zhang, BSc

CONTACT

86-15802990370; ruining-zhang@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Cardiology, Director of the Department of Cardiology

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: January 30, 2026
• Study Start: August 18, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

CN (1)