Acute Myocardial Infarction (AMI)Phase 3PCAB-AMINCT07467213
Routine Use of Potassium Competitive Acid Blocker vs. Guideline-Directed Gastrointestinal Protection Strategy in Acute Myocardial Infarction
A Phase 3 study testing Zastaprazan and Proton Pump Inhibitors (PPI) in people with Acute Myocardial Infarction (AMI) and Gastrointestinal Bleeding, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study aims to compare the clinical outcomes between routine use of potassium competitive acid blocker (P-CAB) and guideline-directed gastrointestinal (GI) protection strategy in patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI) and being treated with dual… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Myocardial Infarction (AMI), Gastrointestinal Bleeding
- What is being tested?
- Zastaprazan and Proton Pump Inhibitors (PPI)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Jun 2026to 31 Dec 2030
- Phase
- Phase 3
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 19 years or older.
- Patients diagnosed with acute myocardial infarction (ST-segment elevation myocardial infarction [STEMI] or non-ST-segment elevation myocardial infarction [NSTEMI]).
- Patients who underwent percutaneous coronary intervention (PCI) with drug-eluting stents (DES) or drug-coated balloons (DCB).
- Patients (or their legal representatives) who understood the study risks and benefits and provided voluntary written informed consent.
Who cannot join
- History of hypersensitivity (e.g., allergic reaction, anaphylactic shock) or contraindication to study drugs (potassium-competitive acid blocker [P-CAB] or proton pump inhibitor [PPI]).
- Presence of active gastrointestinal bleeding.
- Pregnant or breastfeeding women.
- Non-cardiac life expectancy of less than 1 year or patients expected to have low compliance (as determined by the investigator's medical judgment).
- Patients who refuse to participate or are unable to follow the requirements specified in the study protocol.
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
Jooyoung Hahn, +82 02-3410-6653, jinshil6.kim@sbri.co.kr
About this study
Official title: Routine Use of Potassium Competitive Acid Blocker Versus Guideline-Directed Gastrointestinal Protection Strategy in Patients With Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention on Dual Antiplatelet Therapy: A Randomized Trial
This study aims to compare the clinical outcomes between routine use of potassium competitive acid blocker (P-CAB) and guideline-directed gastrointestinal (GI) protection strategy in patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI) and being treated with dual antiplatelet therapy (DAPT).
Read the detailed description
This is a prospective, open-label, two-arm, randomized, multi-center trial. A total of 5,000 patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI) and receiving dual antiplatelet therapy (DAPT) will be enrolled and randomized in a 1:1 ratio. Patients will be assigned to either the routine use of P-CAB group or the guideline-directed GI protection strategy group. The primary endpoint is the occurrence of Net Adverse Clinical Events (NACE), a composite of death from any causes, myocardial infarction, stroke, or Bleeding Academic Research Consortium (BARC) type 3-5 bleeding at 1 year.
- Being tested
- Zastaprazan, Proton Pump Inhibitors (PPI)
- Keywords
- Percutaneous Coronary Intervention, Dual Antiplatelet Therapy, Potassium Competitive Acid Blocker, Zastaprazan
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZastaprazanDrug
Zastaprazan citrate 20mg will be administered orally once daily for gastrointestinal protection according to the study protocol.
Proton Pump Inhibitors (PPI)Drug
Guideline-directed gastrointestinal protection using various proton pump inhibitors as determined by the physician.
| Study group | Role | What they receive |
|---|---|---|
| Routine Potassium Competitive Acid Blocker Group | Experimental | Not described Receives: Drug: Zastaprazan |
| Guideline-Directed Gastrointestinal Protection Group | Active comparator | Not described Receives: Drug: Proton Pump Inhibitors (PPI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net Adverse Clinical Events (NACE)
A composite of death from any causes, myocardial infarction, stroke, or Bleeding Academic Research Consortium (BARC) type 2, 3-5 bleeding.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start23 Jun 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial Infarction (AMI)Studies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467213
- Sponsor's protocol ID
- SMC 2025-09-069-006
- Acronym
- PCAB-AMI
- Status last verified
- Jun 2026
- First submitted
- 9 Mar 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Use of Potassium Competitive Acid Blocker Versus Guideline-Directed Gastrointestinal Protection Strategy in Patients With Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention on Dual Antiplatelet Therapy: A Randomized Trial
- ClinicalTrials.gov ID
- NCT07467213
- Acronym / sponsor ID
- PCAB-AMI / SMC 2025-09-069-006
- Keywords
- Percutaneous Coronary Intervention, Dual Antiplatelet Therapy, Potassium Competitive Acid Blocker, Zastaprazan
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 23 Jun 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 12 Mar 2026 (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.
This study aims to compare the clinical outcomes between routine use of potassium competitive acid blocker (P-CAB) and guideline-directed gastrointestinal (GI) protection strategy in patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI) and being treated with dual antiplatelet therapy (DAPT).
Detailed description
This is a prospective, open-label, two-arm, randomized, multi-center trial. A total of 5,000 patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI) and receiving dual antiplatelet therapy (DAPT) will be enrolled and randomized in a 1:1 ratio. Patients will be assigned to either the routine use of P-CAB group or the guideline-directed GI protection strategy group. The primary endpoint is the occurrence of Net Adverse Clinical Events (NACE), a composite of death from any causes, myocardial infarction, stroke, or Bleeding Academic Research Consortium (BARC) type 3-5 bleeding at 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Potassium Competitive Acid Blocker Group | Experimental | Drug: Zastaprazan |
| Guideline-Directed Gastrointestinal Protection Group | Active comparator | Drug: Proton Pump Inhibitors (PPI) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 19 years or older.
- Patients diagnosed with acute myocardial infarction (ST-segment elevation myocardial infarction [STEMI] or non-ST-segment elevation myocardial infarction [NSTEMI]).
- Patients who underwent percutaneous coronary intervention (PCI) with drug-eluting stents (DES) or drug-coated balloons (DCB).
- Patients (or their legal representatives) who understood the study risks and benefits and provided voluntary written informed consent.
Key exclusion criteria (5 listed)
- History of hypersensitivity (e.g., allergic reaction, anaphylactic shock) or contraindication to study drugs (potassium-competitive acid blocker [P-CAB] or proton pump inhibitor [PPI]).
- Presence of active gastrointestinal bleeding.
- Pregnant or breastfeeding women.
- Non-cardiac life expectancy of less than 1 year or patients expected to have low compliance (as determined by the investigator's medical judgment).
- Patients who refuse to participate or are unable to follow the requirements specified in the study protocol.
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 |
|---|---|---|
| ZastaprazanZastaprazan citrate 20mg will be administered orally once daily for gastrointestinal protection according to the study protocol. | Drug | Routine Potassium Competitive Acid Blocker Group |
| Proton Pump Inhibitors (PPI)Guideline-directed gastrointestinal protection using various proton pump inhibitors as determined by the physician. | Drug | Guideline-Directed Gastrointestinal Protection Group |
Primary outcome
Net Adverse Clinical Events (NACE)
Time frame: 1 year
A composite of death from any causes, myocardial infarction, stroke, or Bleeding Academic Research Consortium (BARC) type 2, 3-5 bleeding.
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 26 Jun 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zastaprazan and Proton Pump Inhibitors (PPI) in people with Acute Myocardial Infarction (AMI) and Gastrointestinal Bleeding, 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 4 inclusion and 5 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 26 Jun 2026. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Net Adverse Clinical Events (NACE) (time frame: 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 26 Jun 2026.