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AzTrials

Coronary Artery DiseasePhase 4PROTECT-HBRNCT04416581

Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High Gastro-Intestinal Bleeding Risk Receiving Antithrombotic Therapy

A Phase 4 study testing PPI and P-CAB 50 in people with Coronary Artery Disease and Percutaneous Coronary Intervention, run by Duk-Woo Park, MD at 45 sites in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The primary aim of this study is to evaluate the efficacy and safety of novel P-CAB (tegoprazan 50 mg once daily) as compared with standard PPI (rabeprazole 20 mg once daily) for protection of GI events in patients with known cardiac and vascular disease receiving chronic use of antithrombotic drugs (either… Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
PPI and P-CAB 50
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,320 participants
Where
45 sitesSouth Korea
Study dates
12 May 2021to 28 Feb 2028
Phase
Phase 4
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 19 years of age or older with known cardiac and vascular disease who are receiving chronic use of antithrombotic drugs (either antiplatelets, oral anticoagulant (OAC), and its combinations). Specific clinical conditions that may confer a need for long-term antithrombotic therapy may include documented coronary artery disease (stable or unstable angina, acute coronary syndrome, a history of myocardial infarction, or any coronary revascularization), documented cerebrovascular disease (stroke or transient ischemic attack), known peripheral arterial disease or a history of peripheral arterial revascularization, atrial fibrillation, or valvular heart disease requiring interventions (transcatheter aortic valve replacement or transcatheter mitral-valve repair). Concomitant use of a proton pump inhibitor is strongly recommended in patients receiving aspirin monotherapy, DAPT (dual antiplatelet therapy; aspirin plus any P2Y12 inhibitors), DAT (dual antithrombotic therapy; antiplatelet drug plus OAC), TAT (triple antithrombotic therapy; DAPT plus OAC), or OAC monotherapy (warfarin or direct oral anticoagulants) who are at high risk of GI bleeding in order to reduce the risk of gastric bleed or GI events. Based on clinical guidelines, the use of P2Y12 inhibitor monotherapy (i.e. clopidogrel, ticagrelor, or prasugrel) is not considered in trial enrollment.
  • On the basis of clinical guidelines and expert consensus documents, we defined a study population with an increased risk of gastrointestinal bleeding if they had a least 1 or more criteria of the following characteristics. Eligible patients for randomization must meet at least 1 characteristic of these criteria:
  • Definition of patients who are at high risk of gastrointestinal bleeding
  • Age ≥65 years
  • Concomitant use of OAC and any antiplatelet therapy (mono or DAPT) (i.e., DAT or TAT)
  • Long-term use of oral NSAIDs (non-steroidal anti-inflammatory drugs) or steroids or high-dose NSAID therapy even during a relatively short-term period.
Show all 11Show fewer
  • History of prior GI bleeding events at any time
  • History of a previously complicated ulcer
  • History of peptic ulcer disease or a previously uncomplicated ulcer
  • Documented Helicobacter pylori infection
  • Patients who voluntarily participated in the written agreement

Who cannot join

  • Active bleeding at the time of inclusion or a history of hereditary or acquired hemostatic disorder
  • Any clinical contraindication to using of antithrombotic therapies (antiplatelet agents or OAC)
  • Concurrent use of PPI or P-CAB within 4 weeks before randomization
  • Hemodynamically unstable conditions at the time of inclusion: cardiogenic shock at the time of randomization, refractory ventricular arrhythmias, or congestive heart failure (New York Heart Association class IV).
  • Baseline severe anemia (Hgb <8 g/dl at baseline) or transfusion within 4 weeks before randomization
  • Baseline severe thrombocytopenia (platelet count <50,000/mm3)
Show all 22Show fewer
  • Renal failure dependent on dialysis or severe renal insufficiency (creatinine clearance <15 ml/min)
  • Severe chronic liver disease (defined as variceal haemorrhage, ascites, hepatic encephalopathy, or jaundice)
  • Hypersensitivity or contraindication to PPI, P-CAB, any of the product components, or substituted benzimidazoles
  • Use of clarithromycin and hypersensitivity to macrolide antibiotics for Helicobacter pylori eradication
  • Concomitant use of clarithromycin with terfenadine, cisapride, astemizole, or pimozide for Helicobacter pylori eradication
  • Systemic treatment with strong CYP 3A4 and p-glycoprotein (P-GP) inhibitors (e.g., systemic azole antimycotics, such as ketoconazole, and human immunodeficiency virus [HIV]-protease inhibitors, such as ritonavir)
  • Patients who take atazanavir, nelfinavir, or rilpivirine-containing products (see Drug-Drug interaction section)
  • Clinically significant laboratory abnormality at screening (estimated glomerular filtration rate (eGFR) <15 mL/min or elevated liver enzyme [AST, ALT, ALP, total bilirubin] > 3 times upper normal limit [UNL] or any other condition that, in the opinion of the Investigator, precludes participation in the study
  • Any known or suspected malignancy
  • Patients with non-cardiac co-morbidities with a life expectancy of less than 12 months
  • Patients with active treatment for H-pylori infection
  • Women who are pregnant or breastfeeding or female subjects, premenopausal who are not surgically sterile, or, if sexually active not practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and, for those of childbearing potential, who have a positive pregnancy test at screening
  • Participation in another clinical study within 12 months. However, where at least one or more conditions are satisfied, it could be an exception according to an investigator's discretion;
  • Participated in the observational study expected no effect on the safety and/or effectiveness evaluation of this trial
  • Screening failed before any interventional factor is involved
  • Participated in academic trials like strategic or medical device comparison studies conducted under standard therapy provided that there is no additional risk or a specific procedure to a subject and no interference between this trial and other studies

Trial locations and contacts

45 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jeong-youn Bae, RN contact

82230107259

cvcrc10@amc.seoul.kr

45 sites in 1 country

South Korea45 sites, 38 recruiting

  • Hallym University Sacred Heart Hospital

    Anyang

    Sang-ho Cho, MD

    Sang-ho Cho, MD

    Recruiting

  • Bucheon Sejong Hospital

    Bucheon-si

    Young-jin Choi, MD

    Young-jin Choi, MD

    Recruiting

  • Kosin University Gospel Hospital

    Busan

    Jung-ho Heo, MD

    Jung-ho Heo, MD

    Recruiting

  • Gyeongsang National University Changwon Hospital

    Changwon

    Withdrawn

  • Sungkyunkwan University Samsung Changwon Hospital

    Changwon

    Withdrawn

  • Dankook University Hospital

    Cheonan

    Withdrawn

  • Chungbuk National University Hospital

    Cheonju

    Sang-min Kim, MD

    Sang-min Kim, MD

    Recruiting

  • Gangwon National Univ. Hospital

    Chuncheon

    Bong-ki Lee, MD

    Bong-ki Lee, MD

    Not yet recruiting

  • Hallym University Chuncheon Sacred Heart Hospital

    Chuncheon

    Hyun-hee Choi, MD

    Hyun-hee Choi, MD

    Not yet recruiting

  • Keimyung University Dongsan Medical Center

    Daegu

    Chang-wook Nam, MD

    Chang-wook Nam, MD

    Recruiting

  • Yeungnam University Medical Center

    Daegu

    Withdrawn

  • Chungnam National University Hospital

    Daejeon

    Jin-ok Jeong, MD

    Jin-ok Jeong, MD

    Recruiting

  • Gangneung Asan Hospital

    Gangneung

    Han-bit Park, MD

    Han-bit Park, MD

    Recruiting

  • Hanyang University Guri Hospital

    Guri-si

    Hwan-cheol Park, MD

    Hwan-cheol Park, MD

    Recruiting

  • Chonnam National University Hospital

    Gwangju

    Young-joon Hong, MD

    Young-joon Hong, MD

    Recruiting

  • Hallym University Dongtan Sacred Heart Hospital

    Hwaseong-si

    Jin-Hwa Lee, MD

    Jin-Hwa Lee, MD

    Recruiting

  • Inje University Ilsan Paik Hospital

    Ilsan

    Seong-wook Kwon, MD

    Seong-wook Kwon, MD

    Recruiting

  • Jeonbuk National University Hospital

    Jeonju

    Withdrawn

  • Kwangju Christian Hospital

    Kwangju

    Withdrawn

  • Dong-A Medical Center

    Pusan

    Yong-rak Cho, MD

    Yong-rak Cho, MD

    Recruiting

  • Inje University Pusan Paik Hospital

    Pusan

    Tae-hyun Yang, MD

    Tae-hyun Yang, MD

    Recruiting

  • Pusan National University Hospital

    Pusan

    Jeong-Cheon Choi, MD

    Jeong-Cheon Choi, MD

    Recruiting

  • Chungnam National University Sejong Hospital

    Sejong

    Won-mook Hwang, MD

    Won-mook Hwang, MD

    Recruiting

  • Bundang CHA Hospital

    Seongnam

    Seung-Ryul Lee, MD

    Seung-Ryul Lee, MD

    Recruiting

  • Seoul university Bundang hospital

    Seongnam-si

    Jung-won Suh, MD

    Jung-won Suh, MD

    Recruiting

  • Asan Medical Center

    Seoul

    Duk-woo Park, MD, dwpark@amc.seoul.kr

    Duk-woo Park, MD

    Recruiting

  • Chung-Ang University Hospital

    Seoul

    Wang-soo Lee, MD

    Wang-soo Lee, MD

    Recruiting

  • Ewha Womans University Medical Center

    Seoul

    Withdrawn

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul

    Seong-Hoon Choi, MD

    Seong-Hoon Choi, MD

    Recruiting

  • Hanyang University Seoul Hospital

    Seoul

    Young-hyo Lim, MD

    Young-hyo Lim, MD

    Recruiting

  • Kangbuk Samsung Hospital

    Seoul

    Seung-Jae Lee, MD

    Seung-Jae Lee, MD

    Recruiting

  • Korea University Anam Hospital

    Seoul

    Soon-jun Hong, MD

    Soon-jun Hong, MD

    Recruiting

  • Korea University Guro Hospital

    Seoul

    Kyung-Yeon Lee, MD

    Kyung-Yeon Lee, MD

    Recruiting

  • Kyung Hee University Hospital at Gangdong

    Seoul

    Eun-seon Jin, MD

    Eun-seon Jin, MD

    Recruiting

  • Kyung Hee University Medical Center

    Seoul

    Won Kim, MD

    Won Kim, MD

    Recruiting

  • Seoul National University Hospital

    Seoul

    Eui-keun Choi, MD

    Eui-keun Choi, MD

    Recruiting

  • Severance Hospital

    Seoul

    Byoung-keuk Kim, MD

    Byoung-keuk Kim, MD

    Recruiting

  • SNU Boramae Medical Center

    Seoul

    Sang-hyun Kim, MD

    Sang-hyun Kim, MD

    Recruiting

  • The Catholic Univ. of Korea Eunpyeong St. Mary's hospital

    Seoul

    Jeong-hoon Lee, MD

    Jeong-hoon Lee, MD

    Recruiting

  • The Catholic Univ. of Korea Seoul St. Mary's hospital

    Seoul

    Byung-hee Hwang, MD

    Byung-hee Hwang, MD

    Recruiting

  • Ajou University Hospital

    Suwon

    Myoung-ho Yoon, MD

    Myoung-ho Yoon, MD

    Recruiting

  • The Catholic University of Korea, ST. Vincent's Hospital

    Suwon

    Sung-ho Her, MD

    Sung-ho Her, MD

    Recruiting

  • Ulsan University Hospital

    Ulsan

    Eun-seok Shin, MD

    Eun-seok Shin, MD

    Recruiting

  • Pusan National University Yangsan Hospital

    Yangsan

    Ki-Won Hwang, MD

    Ki-Won Hwang, MD

    Recruiting

  • Yonsei University Yongin Severance Hospital

    Yongin-si

    Yong-Cheol Kim, MD

    Yong-Cheol Kim, MD

    Recruiting

Other trials in South Korea

About this study

Official title: A Multi-centre, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Phase 4 Efficacy and Safety Study of P-CAB (Tegoprazan 50 mg Once Daily) Compared With PPI (Rabeprazole 20 mg Once Daily) to Reduce Upper Gastrointestinal Events Including Bleeding and Symptomatic Ulcer Disease

The primary aim of this study is to evaluate the efficacy and safety of novel P-CAB (tegoprazan 50 mg once daily) as compared with standard PPI (rabeprazole 20 mg once daily) for protection of GI events in patients with known cardiac and vascular disease receiving chronic use of antithrombotic drugs (either antiplatelets, OAC, and its combinations) who are at high GI bleeding risk. The primary hypothesis is that P-CAB (experimental arm) would non-inferior to PPI (standard arm) with respect to the rate of the primary composite end point of GI events at 12 months after randomization.

Read the detailed description

Before randomization phase, one lead-in subject (N = 300 patients) will be enrolled to perform safety surveillance of standard-dose tegoprazan (50 mg for 6 months) and to ensure the safety of tegoprazan (safety surveillance phase). Data on lead-in subjects will not be included in the data set used for primary analyses.

The safety of tegoprazan will be estimated SIAEs(Special Interest Adverse Events) as follows; Composite Event

  1. liver function abnormalities
  2. hypergastrinemia, or
  3. enteric infection

Definitions

  • liver function abnormality: defined as AST or ALT>3× upper limit of normal or two consecutive measurements of total bilirubin >2 x upper limit of normal
  • hypergastrinemia
  • enteric infection including C.difficile infection

If there are any new tegoprazan-related findings, it will be considered in the estimation.

If there is no safety concern during safety surveillance phase, investigator-driven, randomized, double-blind, double-dummy, active-controlled, clinical trial (N =3,320 patients) will be subsequently performed (randomization phase).

Being tested
PPI, P-CAB 50
Keywords
gastroduodenal ulcer, gastrointestinal hemorrhage, peptic ulcer, acute coronary syndrome, coronary artery stent placement, antiplatelet, anticoagulant therapy, PPI, P-CAB, Proton-pump inhibitors, Potassium-Competitive Acid Blockers
Medical subject headings
Coronary Artery Disease, Acute Coronary Syndrome, Myocardial Infarction, Peptic Ulcer, Gastrointestinal Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PPIDrug

    rabeprazole 20mg + tegoprazan 50 mg placebo, once daily.

  • P-CAB 50Drug

    tegoprazan 50 mg + rabeprazole 20mg placebo, once daily.

Study groups in NCT04416581
Study groupRoleWhat they receive
P-CAB 50mg groupExperimentaltegoprazan 50 mg + rabeprazole 20mg placebo, once daily.
Receives: Drug: P-CAB 50
PPI groupActive comparatorrabeprazole 20mg + tegoprazan 50 mg placebo, once daily.
Receives: Drug: PPI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The time from randomization to the first occurrence of a composite endpoint of upper GI clinical events, including during the treatment period

    This composite outcome included:

    1. Overt upper gastrointestinal bleeding (confirmed by means of upper endoscopy or computed tomography);
    2. Overt upper gastrointestinal bleeding of unknown origin;
    3. Bleeding of presumed occult gastrointestinal origin with a documented decrease in haemoglobin of ≥ 2 g/dL or decrease in hematocrit ≥ 10% from baseline;
    4. Symptomatic gastroduodenal ulcer (confirmed by means of endoscopy or computed tomography) without evidence of gastrointestinal bleeding;
    5. Persistent pain of presumed gastrointestinal origin (duration ≥ 3 days) with underlying multiple erosive disease (5 or more gastroduodenal erosions confirmed by means of endoscopy);
    6. Gastrointestinal obstruction; or
    7. Gastrointestinal perforation.

    A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event is considered to have occurred if any of several different events is observed.

    Measured: 12 months

Secondary outcomes (16)

  1. The event rate of overt upper gastrointestinal bleeding (confirmed by means of upper endoscopy or computed tomography)

    Measured: 12 months

  2. The event rate of overt upper GI bleeding of unknown origin

    Measured: 12 months

  3. The event rate of bleeding of presumed occult GI origin with the documented decrease in Hgb of≥2g/dL or decrease in hematocrit≥10% from baseline

    Measured: 12 months

  4. The event rate of symptomatic gastroduodenal ulcer(confirmed by means of endoscopy or computed tomography) without evidence of GI bleeding

    Measured: 12 months

  5. The event rate of the existence of persistent pain of presumed GI origin(duration ≥ 3 days) with underlying multiple erosive diseases (5 or more gastroduodenal erosions confirmed by means of endoscopy)

    Measured: 12 months

  6. The event rate of gastrointestinal obstruction

    Measured: 12 months

  7. The event rate of gastrointestinal perforation

    Measured: 12 months

  8. The time from randomization to discontinuation of study medication attributed to gastrointestinal signs or symptoms

    Measured: 12 months

  9. The event rate of gastroesophageal reflux disease, as evidenced by symptomatic endoscopically confirmed erosive esophagitis

    Measured: 12 months

  10. The event rate of composite cardiovascular safety endpoints

    composite cardiovascular safety endpoints including:

    1. death from cardiovascular causes;
    2. myocardial infarction; or
    3. stroke

    A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event that is considered to have occurred if any one of several different events is observed.

    Measured: 12 months

  11. The event rate of death from cardiovascular causes

    Measured: 12 months

  12. The event rate of myocardial infarction

    Measured: 12 months

  13. The event rate of stroke

    Measured: 12 months

  14. The event rate of any coronary or peripheral revascularization

    Measured: 12 months

  15. The event rate of all-cause mortality

    Measured: 12 months

  16. The event rate of any possible side effect of proton pump inhibitor (PPI) or Potassium-competitive acid blocker (PCAB)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2020
  2. Study start12 May 2021
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion28 Feb 2028 (estimated)

Resources

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
3,320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04416581
Sponsor's protocol ID
AMCCV2020-05
Acronym
PROTECT-HBR
Status last verified
Aug 2026
First submitted
28 May 2020
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Lee J, Park HS, Lee J, Choi KD, Kang DY, Ahn JM, Kim W, Lee JY, Lim YH, Kang SH, Kwon SU, Park H, Choi EK, Hong SJ, Kim BK, Jin ES, Jeong JO, Nam CW, Lee WS, Kim SM, Park KH, Her SH, Shin ES, Choi YJ, Yang TH, Kim SH, Suh JW, Park HC, Yoon YH, Yoon MH, Park SJ, Park DW; PROTECT-HBR Trial. Potassium-competitive acid blocker vs proton-pump inhibitor in patients receiving antithrombotic therapy who are at high risk for gastrointestinal bleeding: Rationale and design of the randomized PROTECT- HBR trial. Am Heart J. 2025 Sep;287:50-60. doi: 10.1016/j.ahj.2025.04.001. Epub 2025 Apr 4.

    PubMed 40188976

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing PPI and P-CAB 50 in people with Coronary Artery Disease and Percutaneous Coronary Intervention, run by Duk-Woo Park, MD at 45 sites 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 11 inclusion and 22 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 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Contact Jeong-youn Bae, RN (82230107259, cvcrc10@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The time from randomization to the first occurrence of a composite endpoint of upper GI clinical events, including during the treatment period (time frame: 12 months). 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 NCT04416581, 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 28 Aug 2026.

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