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NCT Number: NCT07378137

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Percutaneous Coronary Intervention Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location status: Recruiting

Location contact

Shutong Li, MBBS

CONTACT

[email protected]

13379338216

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

  1. Relative weight of myocardial infarction to death

    Time frame: Before discharge

  2. Relative weight of stroke to death

    Time frame: Before discharge

  3. Relative weight of cardiopulmonary resuscitation to death

    Time frame: Before discharge

  4. Relative weight of procedural complications to death

    Time frame: Before discharge

  5. Relative weight of major bleeding events to death

    Time frame: Before discharge

  6. Relative weight of acute kidney injury to death

    Time frame: Before discharge

  7. Relative weight of revascularization to death

    Time frame: Before discharge

  8. Relative weight of rehospitalization to death

    Time frame: Before discharge

Study contacts

Contact information is provided by the study sponsor or research team.

Ruining Zhang, BSc

CONTACT

[email protected]

86-15802990370

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

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

Acronym: REC-CHARTENDS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 30, 2026
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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