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Emulation of Randomized Clinical Trial in Cardiovascular Disease

Emulation of Randomized Clinical Trial in Cardiovascular Disease

Recruiting
40-80 years
All
Phase N/A

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Overview

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.

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 details
    Myocardial Infarction

NCT06241833

Samsung Medical Center

22 February 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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