Comparing the Components of Composite Endpoints for Healthcare Providers and Patients (REC-CHARTENDS)

A Preference Study Comparing the Components of Composite Endpoints for Healthcare Providers and Patients With CAD

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention
• Intervention / Treatment: Other: Questionnaire

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Ruining Zhang, BSc; Phone Number: 86-15802990370; Email: ruining-zhang@qq.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Xijing Hospital
      • Contact: Shutong Li, MBBS; Phone Number: 13379338216; Email: shutongli@fmmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Healthcare providers and patients with CAD

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects; Medical staff and patients with CAD	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Study Chair: Ling Tao, M.D., Ph.D, Xijing Hospital; Study Chair: Chao Gao, M.D., Ph.D, Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: January 22, 2026
• First Submitted That Met QC Criteria: January 22, 2026
• First Posted (Actual): January 30, 2026

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: coronary artery disease; composite endpoints
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: REC-CHARTENDS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No