NCT06736626Completed
The xDAPT External Validation Study
External Validation of an Individualized Patient Centered Machine Learning Model for the Prediction of Ischemic and Bleeding Risk in Patients on Dual Antiplatelet Therapy After Percutaneous Coronary Intervention
Source: ClinicalTrials.gov · Last updated 24 Mar 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 30000 (actual)
- First submitted
- 12 Dec 2024
- Start date
- 1 Jan 2012
- Primary completion date
- 31 Dec 2022
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Diseases
- Coronary artery disease
- NCT number
- NCT06736626
What you commit to
- Study type: Observational
- Participants enrolled: 30000
- From 1 Jan 2012 to the primary completion date, 31 Dec 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Cardiogenic shock or cardiac arrest as indication to PCI
Other
- PCI with bare-metal stents (BMS) or balloon angioplasty only
- In-hospital mortality
- No available clinical follow-up
- Missing data from any of the variables included in the risk models
Who the study is looking for
- Consecutive patients undergoing PCI with any DES implantation at Mount Sinai Hospital (New York, US) between January, 2012 and December, 2022.
- Age ≥18 years
- Ability to provide informed consent for the procedure and subsequent data collection
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.