Myocardial InfarctionRCT-BigDataNCT06241833
Emulation of Randomized Clinical Trial in Cardiovascular Disease
An observational study of Myocardial Infarction and Coronary Artery Disease, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Myocardial Infarction, Coronary Artery Disease
- What is being tested?
- PPI
- How many people
- 118,420 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 May 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with AMI undergoing PCI
Who may be able to join
- - 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
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul
Ki Hong Choi, MD, 82-2-3410-3419, cardiokh@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Myocardial Infarction, Coronary Artery Disease
- Being tested
- PPI
- Keywords
- Percutaneous coronary intervention, Cardiovascular Pharmacotherapy, Proton pump inhibitor, Dual antiplatelet therapy
- Medical subject headings
- Myocardial Infarction, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPIDrug
Also called GI protection
use of PPI concomitant with DAPT
| Study group | Role | What they receive |
|---|---|---|
| PPI group | Patients receiving PPI concomitant with dual antiplatelet therapy after PCI for AMI Receives: Drug: PPI | |
| no PPI group | Patients receiving dual antiplatelet therapy only after PCI for AMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of Major GI bleeding requiring transfusion
Efficacy outcome
Measured: 1-year follow-up
Rates of Major adverse cardiac event
Safety outcome, a composite of cardiac death, MI, ischemic stroke, and repeat revascularization
Measured: 1-year follow-up
Secondary outcomes (5)
Rates of Major or Minor GI bleeding with hospitalization
Efficacy outcome
Measured: 1-year follow-up
Rates of Cardiac death
Cardiac death
Measured: 1-year follow-up
Rates of Spontaneous MI
Spontaneous MI
Measured: 1-year follow-up
Rates of Ischemic stroke
Ischemic stroke
Measured: 1-year follow-up
Rates of Repeat revascularization
Repeat revascularization
Measured: 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start30 May 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 118,420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ki Hong Choi, Samsung Medical Center
- Investigators
- Ki Hong Choi, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241833
- Sponsor's protocol ID
- CVD-Emulation
- Acronym
- RCT-BigData
- Status last verified
- Mar 2024
- First submitted
- 28 Jan 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39962947
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of PPI on GI Bleeding and Cardiovascular Outcomes Among Post-MI Patients Taking DAPT
- ClinicalTrials.gov ID
- NCT06241833
- Acronym / sponsor ID
- RCT-BigData / CVD-Emulation
- Conditions
- Myocardial Infarction, Coronary Artery Disease
- Keywords
- Percutaneous coronary intervention, Cardiovascular Pharmacotherapy, Proton pump inhibitor, Dual antiplatelet therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 118,420 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 30 May 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPI group | – | Drug: PPIPatients receiving PPI concomitant with dual antiplatelet therapy after PCI for AMI |
| no PPI group | – | –Patients receiving dual antiplatelet therapy only after PCI for AMI |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with AMI undergoing PCI
Key inclusion criteria (3 listed)
- - 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
Key exclusion criteria (8 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PPIAlso: GI protectionuse of PPI concomitant with DAPT | Drug | PPI group |
Primary outcome
Rates of Major GI bleeding requiring transfusion
Time frame: 1-year follow-up
Efficacy outcome
Rates of Major adverse cardiac event
Time frame: 1-year follow-up
Safety outcome, a composite of cardiac death, MI, ischemic stroke, and repeat revascularization
5 secondary outcomes
Rates of Major or Minor GI bleeding with hospitalization
Time frame: 1-year follow-up
Rates of Cardiac death
Time frame: 1-year follow-up
Rates of Spontaneous MI
Time frame: 1-year follow-up
Rates of Ischemic stroke
Time frame: 1-year follow-up
Rates of Repeat revascularization
Time frame: 1-year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Derived from this study: PubMed 39962947Kang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ki Hong Choi, MD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction and Coronary Artery Disease, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ki Hong Choi, MD (82-2-3410-3419, cardiokh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of Major GI bleeding requiring transfusion (time frame: 1-year follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06241833, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.