Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07479056
Brief Summary:
The use of antiplatelet agents inevitably increases the risk of bleeding, which is associated with increasing the risk of mortality. Gastrointestinal bleeding, including upper gastrointestinal bleeding, is the most common bleeding complication, accounting for about 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, with the COGENT study being 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 the antiplatelet effect and increase the risk of thrombotic events.
Currently, European clinical guidelines recommend prescribing PPIs as gastrointestinal protective agents to all patients, while ACCF/ACC/AHA clinical guidelines recommend prescribing PPIs only to patients at high risk of upper gastrointestinal bleeding and prohibit their 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% of patients were identified to be at high risk of bleeding within 1 year after coronary artery intervention according to the BARC 3 or 5 bleeding criteria. Additionally, it is known that East Asians, including Koreans, are at a higher risk of upper gastrointestinal bleeding due to various genetic and environmental factors. Therefore, efforts to prevent gastrointestinal bleeding during the period of dual antiplatelet therapy after stent insertion are even more necessary.
Potassium-competitive acid blockers (P-CABs) are a new class of H+/K+ ATPase inhibitors used to treat gastrointestinal acid-related disorders such as gastroesophageal reflux disease, peptic ulcers, and Helicobacter pylori infections. Unlike proton pump inhibitors, 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. The newly developed drug Fexuprazan (FexuclueⓇ) has been proven effective through phase III clinical trials for patients with erosive esophagitis, and it is confirmed to be activated more quickly than the PPI, Ezomezole, and to have a sustained drug effect throughout the night. Therefore, in this double-blind, randomized, active-controlled study, we aim to evaluate the preventive effect of Fexuprazan (FexuclueⓇ) with improved gastrointestinal protection on upper gastrointestinal bleeding in high-risk patients who require dual antiplatelet therapy.
Study:
NCT07479056
Study Brief:
Protocol Section:
NCT07479056