Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06241833
Status:
RECRUITING
Last Update Posted:
2024-03-26
First Post:
2024-01-28
Brief Title:
Emulation of Randomized Clinical Trial in Cardiovascular Disease
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
Effects of PPI on GI Bleeding and Cardiovascular Outcomes Among Post-MI Patients Taking DAPT
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RCT-BigData
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 inclusionexclusion 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None