NCT07479056

Fexuprazan for Prevention of Upper Gastrointestinal Bleeding in High Bleeding Risk Patients Receiving Dual Antiplatelet Therapy

Randomized Active-Controlled Trial Evaluating Fexuprazan for Prevention Upper Gastrointestinal Bleeding in High Bleeding Risk Patients Receiving Dual Antiplatelet Therapy After Coronary Intervention-Fexuprazan for Patients With Dual Antiplatelet Therapy Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: SUK MIN SEO · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates whether fexuprazan is effective in preventing upper gastrointestinal bleeding and related upper gastrointestinal clinical events in high bleeding risk patients who require dual antiplatelet therapy after coronary stent implantation. A total of 400 participants at a single center will be randomly assigned in a 1:1 ratio within 48 hours after stent implantation to receive either fexuprazan 40 milligrams or lansoprazole 30 milligrams once daily for 6 months. The study will compare upper gastrointestinal clinical events during follow-up

Detailed description

The use of antiplatelet agents inevitably increases the risk of bleeding, which is associated with increased mortality. Gastrointestinal bleeding, including upper gastrointestinal bleeding, is the most common bleeding complication, accounting for approximately two-thirds of bleeding events associated with dual antiplatelet therapy (DAPT). The use of proton pump inhibitors (PPIs) has been investigated to reduce the risk of gastrointestinal bleeding, and the Clopidogrel and the Optimization of Gastrointestinal Events Trial (COGENT) was the only large study to report a reduction in gastrointestinal bleeding with PPI use. However, smaller randomized trials and meta-analyses have reported conflicting results regarding the efficacy of PPI use. In addition, PPIs require caution when used in conjunction with P2Y12 inhibitors such as clopidogrel, as they may reduce antiplatelet activity and increase the risk of thrombotic events. Currently, European clinical guidelines recommend prescribing PPIs as gastrointestinal protective agents to all patients, whereas American College of Cardiology Foundation, American College of Cardiology, and American Heart Association (ACCF/ACC/AHA) clinical guidelines recommend prescribing PPIs only to patients at high risk of upper gastrointestinal bleeding rather than universal use. With an increase in coronary stenting among elderly and high-risk patients with coronary artery disease, the population at high risk of bleeding is also increasing. Approximately 20 percent of patients were identified as being at high risk of bleeding within 1 year after coronary artery intervention according to Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding criteria. Additionally, East Asians, including Koreans, are known to be at higher risk of upper gastrointestinal bleeding because of various genetic and environmental factors. Therefore, efforts to prevent gastrointestinal bleeding during the period of DAPT after stent insertion are increasingly important. Potassium-competitive acid blockers (P-CABs) are a new class of hydrogen/potassium adenosine triphosphatase (H+/K+ ATPase) inhibitors used to treat gastrointestinal acid-related disorders such as gastroesophageal reflux disease, peptic ulcers, and Helicobacter pylori infections. Unlike PPIs, which bind to the proton pump, P-CABs competitively and reversibly inhibit the potassium site of H+/K+ ATPase, leading to relatively long-lasting inhibition of acid secretion. Fexuprazan (Fexuclue) has demonstrated efficacy in phase 3 clinical trials in patients with erosive esophagitis and has been shown to have a faster onset of action than esomeprazole and sustained acid suppression throughout the night. Therefore, this double-blind, randomized, active-controlled study was designed to evaluate the preventive effect of fexuprazan on upper gastrointestinal events in high-risk patients who require DAPT. A total of 400 participants at a single center will be enrolled. Eligible participants will be randomly assigned in a 1:1 ratio within 48 hours after stent implantation to receive either fexuprazan 40 milligrams or lansoprazole 30 milligrams

Conditions

• Acute Coronary Syndromes (ACS)
• Coronary Artery Disease (CAD)

Interventions

Type	Name	Description
DRUG	Fexuprazan 40mg	Fexuprazan 40 mg orally once daily + Lansoprazole placebo Matching placebo orally once daily.
DRUG	Lansoprazole 30mg	Lansoprazole 30 mg orally once daily. + Fexuprazan placebo Matching placebo orally once daily.

Timeline

• Start date: 2024-10-24
• Primary completion: 2028-04-30
• Completion: 2028-12-31
• First posted: 2026-03-18
• Last updated: 2026-04-08

Locations

1 site across 1 country: South Korea