Emulation of Randomized Clinical Trial in Cardiovascular Disease

Recruiting

• Conditions: Myocardial Infarction; Coronary Artery Disease
• Interventions: Drug: PPI

• Registration Number: NCT06241833
• Lead Sponsor: Samsung Medical Center

Brief 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.

Study Timeline

• Study Start: 2023-05-30
• Study First Submitted: 2024-01-28
• Study First Submitted QC: 2024-01-28
• Study First Posted: 2024-02-05
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-24
• Last Update Posted: 2024-03-26
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 118420

Inclusion Criteria

• • PCI with MI (I21) admission
• Age more than 40 or less than 80 years old
• Aspirin and Clopidogrel/Prasugrel/Ticagrelor prescription with more than 2 days at discharge

Exclusion Criteria

• • Previous use of a PPI, an H2-receptor antagonist, sucralfate, or misoprostol within 30 days before admission
• Preexisting cancer within a year before admission
• History of RBC transfusion
• RBC transfusion in admission
• Cardiogenic Shock
• Length of stay more than 14 days
• OAC prescription with more than 2 days at discharge
• H2 prescription with more than 2 days at discharge

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PPI group	PPI	Patients receiving PPI concomitant with dual antiplatelet therapy after PCI for AMI

Primary Outcome Measures

Name	Time	Method
Rates of Major adverse cardiac event	1-year follow-up	Safety outcome, a composite of cardiac death, MI, ischemic stroke, and repeat revascularization
Rates of Major GI bleeding requiring transfusion	1-year follow-up	Efficacy outcome

Secondary Outcome Measures

Name	Time	Method
Rates of Major or Minor GI bleeding with hospitalization	1-year follow-up	Efficacy outcome
Rates of Cardiac death	1-year follow-up	Cardiac death
Rates of Spontaneous MI	1-year follow-up	Spontaneous MI
Rates of Ischemic stroke	1-year follow-up	Ischemic stroke
Rates of Repeat revascularization	1-year follow-up	Repeat revascularization

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of