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The xDAPT External Validation Study

NCT06736626 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30000

Last updated 2025-03-24

No results posted yet for this study

Summary

Dual antiplatelet therapy (DAPT) is routinely recommended after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation to prevent thrombotic complications. However, DAPT is also associated with an increased risk of bleeding, which may have a similar or even greater impact on prognosis compared to recurrent ischemic events.

To balance these risks, individualized risk stratification at the time of PCI is crucial for determining the optimal DAPT composition and duration, aiming to reduce thrombotic risk while minimizing bleeding complications. For this purpose, an artificial intelligence-based risk stratification tool (xDAPT, Abbott) was introduced and demonstrated strong clinical performance in its development study (ClinicalTrials.gov identifier: NCT06089304).

This analysis aims to evaluate the performance of xDAPT in a real-world cohort of patients who underwent PCI over the past decade at a large urban center (Mount Sinai Hospital, New York).

Conditions

Interventions

DEVICE

Percutaneous coronary intervention

Percutaneous coronary intervention (PCI) is a catheter-based technique performed under fluoroscopic guidance to treat coronary artery disease and restore blood flow to the myocardium. During PCI, coronary vessel patency is generally achieved with drug-eluting stents (DES), which are metallic scaffolds coated with a polymer that carry and gradually release an antiproliferative drug. In the present study, all participants underwent PCI with implantation of DES, and received a subsequent course of dual antiplatelet therapy (DAPT), as clinically indicated.

Sponsors & Collaborators

Principal Investigators

  • Roxana Mehran · Icahn School of Medicine at Mount Sinai

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-01
Primary Completion
2022-12-31
Completion
2024-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Diseases
Companies

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 NCT06736626 on ClinicalTrials.gov