Emulation of Randomized Clinical Trial in Cardiovascular Disease (RCT-BigData)
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Details and patient eligibility
About
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.
Full 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.
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Inclusion criteria
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- 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
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- 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
Trial design
118,420 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Danbee Kang, PhD; Ki Hong Choi, MD
Data sourced from clinicaltrials.gov
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