Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High Gastro-Intestinal Bleeding Risk Receiving Antithrombotic Therapy
NCT ID: NCT04416581
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
3320 participants
INTERVENTIONAL
2021-05-12
2027-12-31
Brief Summary
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Detailed Description
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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 =3,100 patients) will be subsequently performed (randomization phase).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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P-CAB 50mg group
tegoprazan 50 mg + rabeprazole 20mg placebo, once daily.
P-CAB 50
tegoprazan 50 mg + rabeprazole 20mg placebo, once daily.
PPI group
rabeprazole 20mg + tegoprazan 50 mg placebo, once daily.
PPI
rabeprazole 20mg + tegoprazan 50 mg placebo, once daily.
Interventions
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PPI
rabeprazole 20mg + tegoprazan 50 mg placebo, once daily.
P-CAB 50
tegoprazan 50 mg + rabeprazole 20mg placebo, once daily.
Eligibility Criteria
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Inclusion Criteria
2. 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
1. Age ≥65 years
2. Concomitant use of OAC and any antiplatelet therapy (mono or DAPT) (i.e., DAT or TAT)
3. 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.
4. History of prior GI bleeding events at any time
5. History of a previously complicated ulcer
6. History of peptic ulcer disease or a previously uncomplicated ulcer
7. Documented Helicobacter pylori infection
3. Patients who voluntarily participated in the written agreement
Exclusion Criteria
2. Any clinical contraindication to using of antithrombotic therapies (antiplatelet agents or OAC)
3. Concurrent use of PPI or P-CAB within 4 weeks before randomization
4. 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).
5. Baseline severe anemia (Hgb \<8 g/dl at baseline) or transfusion within 4 weeks before randomization
6. Baseline severe thrombocytopenia (platelet count \<50,000/mm3)
7. Renal failure dependent on dialysis or severe renal insufficiency (creatinine clearance \<15 ml/min)
8. Severe chronic liver disease (defined as variceal haemorrhage, ascites, hepatic encephalopathy, or jaundice)
9. Hypersensitivity or contraindication to PPI, P-CAB, any of the product components, or substituted benzimidazoles
10. Use of clarithromycin and hypersensitivity to macrolide antibiotics for Helicobacter pylori eradication
11. Concomitant use of clarithromycin with terfenadine, cisapride, astemizole, or pimozide for Helicobacter pylori eradication
12. 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)
13. Patients who take atazanavir, nelfinavir, or rilpivirine-containing products (see Drug-Drug interaction section)
14. 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
15. Any known or suspected malignancy
16. Patients with non-cardiac co-morbidities with a life expectancy of less than 12 months
17. Patients with active treatment for H-pylori infection
18. 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
19. 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;
1. Participated in the observational study expected no effect on the safety and/or effectiveness evaluation of this trial
2. Screening failed before any interventional factor is involved
3. 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
19 Years
ALL
No
Sponsors
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Duk-Woo Park, MD
OTHER
Responsible Party
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Duk-Woo Park, MD
Associate Professor, Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine
Locations
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Hallym University Sacred Heart Hospital
Anyang, , South Korea
Bucheon Sejong Hospital
Bucheon-si, , South Korea
Kosin University Gospel Hospital
Busan, , South Korea
Gyeongsang National University Changwon Hospital
Changwon, , South Korea
Sungkyunkwan University Samsung Changwon Hospital
Changwon, , South Korea
Dankook University Hospital
Cheonan, , South Korea
Chungbuk National University Hospital
Cheonju, , South Korea
Gangwon National Univ. Hospital
Chuncheon, , South Korea
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Yeungnam University Medical Center
Daegu, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Gangneung Asan Hospital
Gangneung, , South Korea
Hanyang University Guri Hospital
Guri-si, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, , South Korea
Inje University Ilsan Paik Hospital
Ilsan, , South Korea
Jeonbuk National University Hospital
Jeonju, , South Korea
Kwangju Christian Hospital
Kwangju, , South Korea
Dong-A Medical Center
Pusan, , South Korea
Inje University Pusan Paik Hospital
Pusan, , South Korea
Pusan National University Hospital
Pusan, , South Korea
Chungnam National University Sejong Hospital
Sejong, , South Korea
Bundang CHA Hospital
Seongnam, , South Korea
Seoul university Bundang hospital
Seongnam-si, , South Korea
Asan Medical Center
Seoul, , South Korea
Chung-Ang University Hospital
Seoul, , South Korea
Ewha Womans University Medical Center
Seoul, , South Korea
Hanyang University Seoul Hospital
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Kyung Hee University Hospital at Gangdong
Seoul, , South Korea
Kyung Hee University Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
SNU Boramae Medical Center
Seoul, , South Korea
The Catholic Univ. of Korea Eunpyeong St. Mary's hospital
Seoul, , South Korea
The Catholic Univ. of Korea Seoul St. Mary's hospital
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
The Catholic University of Korea, ST. Vincent's Hospital
Suwon, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
Pusan National University Yangsan Hospital
Yangsan, , South Korea
Yonsei University Yongin Severance Hospital
Yongin-si, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Sang-ho Cho, MD
Role: primary
Young-jin Choi, MD
Role: primary
Jung-ho Heo, MD
Role: primary
Sang-min Kim, MD
Role: primary
Hyun-hee Choi, MD
Role: primary
Chang-wook Nam, MD
Role: primary
Jin-ok Jeong, MD
Role: primary
Han-bit Park, MD
Role: primary
Hwan-cheol Park, MD
Role: primary
Young-joon Hong, MD
Role: primary
Jin-Hwa Lee, MD
Role: primary
Seong-wook Kwon, MD
Role: primary
Yong-rak Cho, MD
Role: primary
Tae-hyun Yang, MD
Role: primary
Han-cheol Lee, MD
Role: primary
Won-mook Hwang, MD
Role: primary
Seung-Ryul Lee, MD
Role: primary
Jung-won Suh, MD
Role: primary
Duk-woo Park, MD
Role: primary
Wang-soo Lee, MD
Role: primary
Young-hyo Lim, MD
Role: primary
Seung-Jae Lee, MD
Role: primary
Soon-jun Hong, MD
Role: primary
Eun-seon Jin, MD
Role: primary
Won Kim, MD
Role: primary
Eui-keun Choi, MD
Role: primary
Byoung-keuk Kim, MD
Role: primary
Sang-hyun Kim, MD
Role: primary
Jeong-hoon Lee, MD
Role: primary
Byung-hee Hwang, MD
Role: primary
Myoung-ho Yoon, MD
Role: primary
Sung-ho Her, MD
Role: primary
Eun-seok Shin, MD
Role: primary
Yong-Cheol Kim, MD
Role: primary
References
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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.
Other Identifiers
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AMCCV2020-05
Identifier Type: -
Identifier Source: org_study_id