Emulation of Randomized Clinical Trial in Cardiovascular Disease (RCT-BigData)

Effects of PPI on GI Bleeding and Cardiovascular Outcomes Among Post-MI Patients Taking DAPT

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Infarction; Coronary Artery Disease
• Intervention / Treatment: Drug: PPI

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 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.

• Study Type: Observational
• Enrollment (Estimated): 118420

Contacts and Locations

• Study Contact: Name: Ki Hong Choi, MD; Phone Number: 82-2-3410-3419; Email: cardiokh@gmail.com
• Study Contact Backup: Name: Danbee Kang, PhD; Phone Number: 82-2-2148-7197; Email: dbee.kang@skku.edu

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Samsung Medical Center
    • Contact: Ki Hong Choi, MD; Phone Number: 82-2-3410-3419; Email: cardiokh@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with AMI undergoing PCI

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PPI group; Patients receiving PPI concomitant with dual antiplatelet therapy after PCI for AMI	Drug: PPI; use of PPI concomitant with DAPT; Other Names: GI protection
no PPI group; Patients receiving dual antiplatelet therapy only after PCI for AMI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of Major GI bleeding requiring transfusion	Efficacy outcome	1-year follow-up
Rates of Major adverse cardiac event	Safety outcome, a composite of cardiac death, MI, ischemic stroke, and repeat revascularization	1-year follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of Major or Minor GI bleeding with hospitalization	Efficacy outcome	1-year follow-up
Rates of Cardiac death	Cardiac death	1-year follow-up
Rates of Spontaneous MI	Spontaneous MI	1-year follow-up
Rates of Ischemic stroke	Ischemic stroke	1-year follow-up
Rates of Repeat revascularization	Repeat revascularization	1-year follow-up

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Ki Hong Choi, MD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 28, 2024
• First Submitted That Met QC Criteria: January 28, 2024
• First Posted (Actual): February 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 24, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Percutaneous coronary intervention; Dual antiplatelet therapy; Proton pump inhibitor; Cardiovascular Pharmacotherapy
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Infarction; Infarction; Coronary Artery Disease
• Other Study ID Numbers: CVD-Emulation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No