Coronary Artery DiseasePCAB-PCINCT07068490
Impact of Potassium Competitive Acid Blockers After Percutaneous Coronary Intervention for Efficacy and Safety Outcome: Target Trial Emulation Study.
An observational study of Coronary Artery Disease, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Despite the fact that potassium competitive acid blocker (P-CAB) has been developed for the treatment of gastric ulcer or gastroesophageal reflux disease, the efficacy and safety of P-CAB for the use of gastrointestinal (GI) protection in patients undergoing percutaneous coronary intervention (PCI) and maintaining… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Routine use of P-CAB on DAPT and Guideline Directed Medical Therapy
- How many people
- 100,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Oct 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with coronary artery disease who underwent PCI
Who may be able to join
- Patients who underwent PCI
- Use of either clopidogrel, prasugrel, or ticagrelor in combination with aspirin
- No use of PCAB, PPI, or an H2-receptor within the past month
Who cannot join
- Patients with low GI bleeding risk are taken on PPI
- Patients with high GI bleeding risk do not take PPI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
About this study
Despite the fact that potassium competitive acid blocker (P-CAB) has been developed for the treatment of gastric ulcer or gastroesophageal reflux disease, the efficacy and safety of P-CAB for the use of gastrointestinal (GI) protection in patients undergoing percutaneous coronary intervention (PCI) and maintaining dual antiplatelet therapy (DAPT) remains uncertain.
Read the detailed description
To evaluate the efficacy and safety of routine P-CAB use in patients with coronary artery disease who underwent PCI and maintain DAPT, as compared to guideline-directed proton pump inhibitor (PPI) usage.
- Conditions
- Coronary Artery Disease
- Being tested
- Routine use of P-CAB on DAPT, Guideline Directed Medical Therapy
- Keywords
- percutaeneous coronary intervention, dual antiplatelet therapy, gastrointestinal protection
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine use of P-CAB on DAPTDrug
This group received P-CAB with DAPT after PCI.
Guideline Directed Medical TherapyDrug
This group received PPI or not with DAPT after PCI according to GI bleeding risk.
| Study group | Role | What they receive |
|---|---|---|
| Routine use of P-CAB | All-comer patients with P-CAB Receives: Drug: Routine use of P-CAB on DAPT | |
| Guideline-directed GI protection strategy | Use of PPI or not according to GI bleeding risk Receives: Drug: Guideline Directed Medical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major GI bleeding
Major GI bleeding requiring transfusion
Measured: at 1 year
Secondary outcomes (5)
Clinically relevant GI bleeding
Clinically relevant GI bleeding
Measured: At 1 year
Major adverse cardiac event
A composite of cardiovascular death, myocardial infarction, and repeat revascularization
Measured: At 1 year
Cardiovascular death
Cardiovascular death
Measured: At 1 year
Myocardial infarction
Myocardial infarction
Measured: At 1 year
Repeat revascularization
Repeat revascularization
Measured: At 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start22 Oct 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- 100,000 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, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068490
- Sponsor's protocol ID
- PCAB_TTE
- Acronym
- PCAB-PCI
- Status last verified
- Jul 2025
- First submitted
- 6 Jul 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Potassium Competitive Acid Blockers After Percutaneous Coronary Intervention for Efficacy and Safety Outcome: Target Trial Emulation Study.
- ClinicalTrials.gov ID
- NCT07068490
- Acronym / sponsor ID
- PCAB-PCI / PCAB_TTE
- Conditions
- Coronary Artery Disease
- Keywords
- percutaeneous coronary intervention, dual antiplatelet therapy, gastrointestinal protection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Jul 2025 (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.
Despite the fact that potassium competitive acid blocker (P-CAB) has been developed for the treatment of gastric ulcer or gastroesophageal reflux disease, the efficacy and safety of P-CAB for the use of gastrointestinal (GI) protection in patients undergoing percutaneous coronary intervention (PCI) and maintaining dual antiplatelet therapy (DAPT) remains uncertain.
Detailed description
To evaluate the efficacy and safety of routine P-CAB use in patients with coronary artery disease who underwent PCI and maintain DAPT, as compared to guideline-directed proton pump inhibitor (PPI) usage.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine use of P-CAB | – | Drug: Routine use of P-CAB on DAPTAll-comer patients with P-CAB |
| Guideline-directed GI protection strategy | – | Drug: Guideline Directed Medical TherapyUse of PPI or not according to GI bleeding risk |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with coronary artery disease who underwent PCI
Key inclusion criteria (3 listed)
- Patients who underwent PCI
- Use of either clopidogrel, prasugrel, or ticagrelor in combination with aspirin
- No use of PCAB, PPI, or an H2-receptor within the past month
Key exclusion criteria (2 listed)
- Patients with low GI bleeding risk are taken on PPI
- Patients with high GI bleeding risk do not take PPI
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 |
|---|---|---|
| Routine use of P-CAB on DAPTThis group received P-CAB with DAPT after PCI. | Drug | Routine use of P-CAB |
| Guideline Directed Medical TherapyThis group received PPI or not with DAPT after PCI according to GI bleeding risk. | Drug | Guideline-directed GI protection strategy |
Primary outcome
Major GI bleeding
Time frame: at 1 year
Major GI bleeding requiring transfusion
5 secondary outcomes
Clinically relevant GI bleeding
Time frame: At 1 year
Major adverse cardiac event
Time frame: At 1 year
Cardiovascular death
Time frame: At 1 year
Myocardial infarction
Time frame: At 1 year
Repeat revascularization
Time frame: At 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- 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.
KI HONG CHOI, MD, PhD 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 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 2 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: looking for participants now, as of the sponsor's last update on 16 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ki Hong Choi, MD, PhD (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?
Major GI bleeding (time frame: at 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2025.