Emulation of Randomized Clinical Trial in Cardiovascular Disease

NCT06241833 | Recruiting

• 1 other identifier: CVD-Emulation
• Study Type: observational
• Target: 118,420
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction; Coronary Artery Disease

Keywords

Percutaneous coronary intervention; Cardiovascular Pharmacotherapy; Proton pump inhibitor; Dual antiplatelet therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Rates of Major or Minor GI bleeding with hospitalization

  1-year follow-up

• Rates of Cardiac death

  1-year follow-up

• Rates of Spontaneous MI

  1-year follow-up

• Rates of Ischemic stroke

  1-year follow-up

• Rates of Repeat revascularization

  1-year follow-up

Study Arms (2)

PPI group

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

Drug: PPI

no PPI group

Patients receiving dual antiplatelet therapy only after PCI for AMI

Interventions

PPI DRUG

use of PPI concomitant with DAPT

Also known as: GI protection

PPI group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with AMI undergoing PCI

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

Related Publications (1)

• Kang D, Choi KH, Park H, Heo J, Park TK, Lee JM, Cho J, Yang JH, Song YB, Choi SH, Gwon HC, Hahn JY. Effects of proton pump inhibitors on gastrointestinal bleeding and cardiovascular outcomes in myocardial infarction patients treated with DAPT. EuroIntervention. 2025 Feb 17;21(4):e229-e239. doi: 10.4244/EIJ-D-24-00673.

  PMID: 39962947 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Ki Hong Choi, MD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ki Hong Choi, MD

CONTACT

82-2-3410-3419; cardiokh@gmail.com

Danbee Kang, PhD

CONTACT

82-2-2148-7197; dbee.kang@skku.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 28, 2024
• First Posted: February 5, 2024
• Study Start: May 30, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: March 26, 2024

Record last verified: 2024-03

Locations

KR (1)