Understanding real-world data in cardiovascular disease
Effects of PPI on GI Bleeding and Cardiovascular Outcomes Among Post-MI Patients Taking DAPT
This study is trying to see if using real-world health data can help us understand the outcomes for patients with heart issues who have had a specific heart procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 118420 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Samsung Medical Center Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06241833 on ClinicalTrials.gov |
What this trial studies
This observational study aims to build an empirical evidence base by replicating randomized controlled trials using real-world data from the Korean National Health Insurance Service database. It focuses on patients who have undergone percutaneous coronary intervention for myocardial infarction or coronary artery disease. The study will analyze outcomes and exposures while employing statistical methods to balance measured covariates, despite the lack of randomization in healthcare claims data. The goal is to determine the feasibility of conducting reliable real-world data analyses for specific clinical questions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 to 80 who have experienced a myocardial infarction and undergone percutaneous coronary intervention.
Not a fit: Patients with a history of certain gastrointestinal medications or serious health conditions like cancer or cardiogenic shock may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of treatment outcomes in cardiovascular disease, leading to improved patient care.
How similar studies have performed: Other studies utilizing real-world data to emulate randomized trials have shown promise, indicating that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul
- Samsung Medical Center — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Ki Hong Choi, MD — Samsung Medical Center
- Study coordinator: Ki Hong Choi, MD
- Email: cardiokh@gmail.com
- Phone: 82-2-3410-3419
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.