NCT06241833

Emulation of Randomized Clinical Trial in Cardiovascular Disease

Effects of PPI on GI Bleeding and Cardiovascular Outcomes Among Post-MI Patients Taking DAPT

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 118,420 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

Detailed description

This is a non-randomized, non-interventional study from Korean National Health Insurance Service database. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice.

Conditions

• Myocardial Infarction
• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	PPI	use of PPI concomitant with DAPT

Timeline

• Start date: 2023-05-30
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2024-02-05
• Last updated: 2024-03-26

Locations

1 site across 1 country: South Korea