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American Heart Journal

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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 - 23/05/25

Doi : 10.1016/j.ahj.2025.04.001 
Jinho Lee, MD a, 1, Han-Su Park, MD b, 1, Junghoon Lee, MD c, 1, Kee Don Choi, MD d, Do-Yoon Kang, MD b, Jung-Min Ahn, MD b, Weon Kim, MD a, Jong-Young Lee, MD e, Young-Hyo Lim, MD f, Se Hun Kang, MD g, Sung Uk Kwon, MD h, Hanbit Park, MD i, Eue-Keun Choi, MD j, Soon Jun Hong, MD k, Byeong-Keuk Kim, MD l, Eun-Sun Jin, MD m, Jin-Ok Jeong, MD n, Chang-Wook Nam, MD o, Wang Soo Lee, MD p, Sang Min Kim, MD q, Kyoung-Ha Park, MD r, Sung-Ho Her, MD s, Eun-Seok Shin, MD t, Young Jin Choi, MD u, Tae-Hyun Yang, MD v, Sang-Hyun Kim, MD w, Jung-Won Suh, MD x, Hwan-Cheol Park, MD y, Yong-Hoon Yoon, MD z, Myeong-Ho Yoon, MD aa, Seung-Jung Park, MD b, Duk-Woo Park, MD b, ⁎

The PROTECT-HBR Trial

a Division of Cardiology, Kyung Hee Medical Center, Kyung Hee University College of Medicine, Seoul, South Korea 
b Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea 
c Department of Cardiology, Eunpyeong St. Mary's Hospital, Seoul, South Korea 
d Division of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea 
e Division of Cardiology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea 
f Division of Cardiology, Department of Internal Medicine, College of Medicine, Hanyang University, Seoul, South Korea 
g Department of Cardiology, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, South Korea 
h Department of Cardiology, Ilsan-Paik Hospital, Inje University College of Medicine, Goyang, South Korea 
i Division of Cardiology, Department of Internal Medicine, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, South Korea 
j Department of Internal Medicine, Seoul National University College of Medicine and Seoul National University Hospital, Seoul, South Korea 
k Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, Korea University College of Medicine, Seoul, South Korea 
l Division of Cardiology, Severance Cardiovascular Hospital. Yonsei University College of Medicine, Seoul 
m Department of Cardiology, Kyung Hee University Hospital at Gangdong, Kyung Hee University College of Medicine, Seoul, South Korea 
n Division of Cardiology, Department of Internal Medicine, Chungnam National University Hospital, Chungnam National University College of Medicine, Daejeon, South Korea 
o Division of Cardiology, Department of Internal Medicine, Cardiovascular Center, Keimyung University Dongsan Hospital, Keimyung University College of Medicine, Daegu, South Korea 
p Division of Cardiology, Department of Internal Medicine, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, South Korea 
q Regional Cardiovascular Center, Division of Cardiology, Chungbuk National University Hospital, Cheongju, South Korea 
r Division of Cardiovascular Disease, Hallym University Medical Center, Anyang, South Korea 
s Department of Cardiology, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, South Korea 
t Division of Cardiology, Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea 
u Department of Cardiology, Sejong General Hospital, Bucheon, South Korea 
v Department of Cardiology, Busan Paik Hospital, University of Inje College of Medicine, Busan, South Korea 
w Division of Cardiology, Department of Internal Medicine, Boramae Medical Center, Seoul National University College of Medicine, Seoul, South Korea 
x Department of Cardiology, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea 
y Division of Cardiology, Department of Internal Medicine, Hanyang University Guri Hospital, Guri, South Korea 
z Department of Cardiology, Chungnam National University Sejong Hospital, Chungnam National University School of Medicine, Sejong, South Korea 
aa Department of Cardiology, Ajou University School of Medicine, Suwon, South Korea 

⁎Reprint requests: Duk-Woo Park, MD, PhD, Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, South Korea.Division of CardiologyAsan Medical CenterUniversity of Ulsan College of MedicineOlympic-ro 43-gilSongpa-guSeoul05505South Korea

Highlights

•
PROTECT-HBR is a multicenter, randomized, double-blind trial comparing Potassium-competitive acid blocker (P-CAB) and proton pump inhibitor (PPI).
•
Patient at high risk of gastrointestinal(GI) bleeding receiving chronic antithrombotic therapy were enrolled
•
The primary endpoint is a composite of upper GI clinical events at 12 months.
•
Over 1500 patients have been randomized at 32 sites across South Korea over 2 years.

Le texte complet de cet article est disponible en PDF.

Résumé

Background

Concomitant use of proton pump inhibitor (PPI) is recommended in patients receiving chronic antithrombotic therapy who are at high risk of gastrointestinal (GI) bleeding. However, long-term safety and efficacy of chronic PPI use have been concerned. Potassium-competitive acid blocker (P-CAB) is a novel class of acid suppressants, providing more acid stability, rapid onset of action, less variability with CYP2C19 polymorphisms, and longer duration of action than PPI.

Design

The PROTECT-HBR trial is a multicenter, randomized, double-blind, double-dummy, parallel-group clinical trial. Approximately 3320 patients with known cardiac or vascular disease receiving antithrombotic drugs (either antiplatelet or anticoagulant agents) and who are at high risk of GI bleeding will be randomized to P-CAB (tegoprazan 50mg once daily) or PPI (rabeprazole 20mg once daily) for up to 12 months. The primary endpoint is a composite outcome of upper GI clinical events, including overt or occult GI bleeding, symptomatic gastroduodenal ulcers or erosions, obstruction, or perforation, at 12 months. Secondary endpoints also included cardiovascular events and safety outcomes.

Results

As of December 2024, approximately 1460 patients were enrolled from 32 participating sites in South Korea. The complete enrollment is anticipated at the mid- or late-term of 2025, and the primary results will be available by 2027.

Conclusion

PROTECT-HBR is a large-scale, multicenter, clinical trial, which will provide a pivotal comparison of the efficacy and safety of novel P-CAB, tegoprazan with those of PPI, rabeprazole in patients with documented cardiac or vascular disease receiving chronic antithrombotic drugs and at high risk of GI bleeding.

Clinical Trial Registration

Potassium-Competitive Acid Blocker versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High GastroIntestinal Bleeding Risk Receiving Antithrombotic Therapy (PROTECT-HBR): NCT04416581.

Le texte complet de cet article est disponible en PDF.

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Vol 287

P. 50-60 - septembre 2025 Retour au numéro
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