Emulation of Randomized Clinical Trial in Cardiovascular Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

118420 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-30

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Myocardial Infarction Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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PPI group

Patients receiving PPI concomitant with dual antiplatelet therapy after PCI for AMI

PPI

Intervention Type DRUG

use of PPI concomitant with DAPT

no PPI group

Patients receiving dual antiplatelet therapy only after PCI for AMI

No interventions assigned to this group

Interventions

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PPI

use of PPI concomitant with DAPT

Intervention Type DRUG

Other Intervention Names

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GI protection

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No