Emulation of Randomized Clinical Trial in Cardiovascular Disease

Coronary Artery Disease Clinical Trial

— RCT-BigData  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06241833
• Other study ID #: CVD-Emulation
• Status: Recruiting
• Start date: May 30, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Samsung Medical Center
• Contact: Ki Hong Choi, MD
• Phone: 82-2-3410-3419
• Email: cardiokh[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 118420
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Infarction
• Myocardial Infarction

Intervention

Drug:
• PPI
use of PPI concomitant with DAPT

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of Major GI bleeding requiring transfusion	Efficacy outcome	1-year follow-up
Primary	Rates of Major adverse cardiac event	Safety outcome, a composite of cardiac death, MI, ischemic stroke, and repeat revascularization	1-year follow-up
Secondary	Rates of Major or Minor GI bleeding with hospitalization	Efficacy outcome	1-year follow-up
Secondary	Rates of Cardiac death	Cardiac death	1-year follow-up
Secondary	Rates of Spontaneous MI	Spontaneous MI	1-year follow-up
Secondary	Rates of Ischemic stroke	Ischemic stroke	1-year follow-up
Secondary	Rates of Repeat revascularization	Repeat revascularization	1-year follow-up