Assessment of Safety of Using Antithrombotic Agents during Esophagogastroduodenoscopy：Rationale and Design of the ASAMA Study

Background：Guidelines for the management of anticoagulation and antiplatelet therapy during endoscopic procedures have been established by the Japanese Circulation Society and the Japan Gastroenterological Endoscopy Society. However, these Japanese guidelines are not in accordance with those of the American Society for Gastrointestinal Endoscopy(ASGE). The ASGE guidelines indicate that aspirin and warfarin may be continued for endoscopic procedures associated with a low risk of bleeding. In contrast, the Japanese guidelines recommend cessation of antithrombotic agents before endoscopy, even if the procedure is classified as low risk. In this trial, we investigate the feasibility of performing esophagogastroduodenoscopy(EGD) with biopsy without the cessation of antithrombotic agents in Japanese patients, in accordance with the ASGE guidelines. Methods and Results：This investigation is a prospective, non-randomized, multicenter trial of patients who undergo scheduled EGD with biopsy while under antithrombotic therapy. Patients will either continue to take antithrombotic agents (group A)or discontinue their use (group B). Control subjects not under antithrombotic therapy will also be recruited (group C). The primary endpoint is gastrointestinal hemorrhage and the secondary endpoint is a cardiovascular event. Summary：This is the first multicenter trial in Japan to investigate the safety of continuing antithrombotic therapy during EGD with biopsy.