Potassium-competitive acid blocker versus 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

IF 3.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal Pub Date : 2025-04-04 DOI:10.1016/j.ahj.2025.04.001

Jinho Lee MD , Han-Su Park MD , Junghoon Lee MD , Kee Don Choi MD , Do-Yoon Kang MD , Jung-Min Ahn MD , Weon Kim MD , Jong-Young Lee MD , Young-Hyo Lim MD , Se Hun Kang MD , Sung Uk Kwon MD , Hanbit Park MD , Eue-Keun Choi MD , Soon Jun Hong MD , Byeong-Keuk Kim MD , Eun-Sun Jin MD , Jin-Ok Jeong MD , Chang-Wook Nam MD , Wang Soo Lee MD , Sang Min Kim MD , Duk-Woo Park MD

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Abstract

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.

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在接受抗血栓治疗的胃肠道出血高风险患者中，钾竞争性酸阻滞剂与质子泵抑制剂的对比：随机PROTECT- HBR试验的基本原理和设计

背景：建议接受慢性抗血栓治疗的胃肠道（GI）出血高危患者同时使用质子泵抑制剂（PPI）。然而，长期使用质子泵抑制剂的安全性和有效性一直备受关注。钾竞争性胃酸阻滞剂（P-CAB）是一类新型抑酸剂，与 PPI 相比，它具有更高的胃酸稳定性、起效迅速、随 CYP2C19 多态性变化较小以及作用持续时间更长等特点：PROTECT-HBR 试验是一项多中心、随机、双盲、双哑药、平行组临床试验。约 3320 名已知患有心脏或血管疾病、正在服用抗血栓药物（抗血小板或抗凝剂）且消化道出血风险较高的患者将随机接受 P-CAB（替戈普拉赞 50 毫克，每天一次）或 PPI（雷贝拉唑 20 毫克，每天一次）治疗，疗程长达 12 个月。主要终点是12个月时上消化道临床事件的综合结果，包括明显或隐匿性消化道出血、症状性胃十二指肠溃疡或糜烂、梗阻或穿孔。次要终点还包括心血管事件和安全性结果：截至 2024 年 12 月，韩国 32 个参与研究的机构共招募了约 1460 名患者。预计将于 2025 年中期或晚期完成全部入组工作，并于 2027 年得出主要结果：PROTECT-HBR是一项大规模、多中心临床试验，它将对新型P-CAB、替戈普拉赞与PPI、雷贝拉唑的疗效和安全性进行关键性比较，适用于有记录的患有心脏或血管疾病、长期服用抗血栓药物且消化道出血风险较高的患者：临床试验注册：接受抗血栓治疗的胃肠道出血高风险患者的胃肠道治疗策略：钾竞争性酸阻滞剂与钾离子泵抑制剂（PROTECT-HBR）：NCT04416581。

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来源期刊

American heart journal 医学-心血管系统

CiteScore

8.20

自引率

2.10%

发文量

214

审稿时长

38 days

期刊介绍： The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.