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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06241833
Other study ID # CVD-Emulation
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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