Timing of Endoscopy in Coronary Heart Disease Patients Taking Antiplatelet Drugs With Acute Non-variceal Upper Gastrointestinal Bleeding

Официальное название

A Prospective Randomized Controlled Study on the Timing of Endoscopy in Coronary Heart Disease Patients Taking Antiplatelet Drugs With Acute Non-variceal Upper Gastrointestinal Bleeding

Обзор

This is a prospective randomized controlled trial (RCT) evaluating the optimal timing of endoscopy in patients with coronary heart disease who are taking antiplatelet drugs and present with acute non-variceal upper gastrointestinal bleeding. Eligible patients will be randomly assigned to one of two groups: an urgent endoscopy group (undergoing endoscopy within 12 hours of hospital admission) or an early endoscopy group (undergoing endoscopy between 12 and 24 hours after admission). All patients will receive standard medical treatment for upper gastrointestinal bleeding and antiplatelet management in accordance with current clinical guidelines. The primary outcome of this study is the incidence of major adverse cardiovascular events (MACE) within 30 days between the two groups. Secondary outcomes include further bleeding events, all-cause mortality, length of hospital stay, and the need for blood transfusion during the follow-up period. This research aims to generate evidence-based clinical guidance on the safest and most effective endoscopy timing for this high-risk patient population.

Вмешательства

• Процедура Urgent Endoscopy (Within 12 Hours of Admission)
  Urgent endoscopy performed within 12 hours after the patient is admitted to the hospital, used to diagnose and treat acute non-variceal upper gastrointestinal bleeding.
• Процедура Early Endoscopy (12-24 Hours After Admission)
  Early endoscopy performed between 12 and 24 hours after the patient is admitted to the hospital, used to diagnose and treat acute non-variceal upper gastrointestinal bleeding.

Первичные конечные точки

• major adverse cardiovascular events (MACE) [Срок оценки: Within 30 days after randomization]

Вторичные конечные точки (4)

• Further bleeding [Срок оценки: Within 7 days after randomization]
• All-cause mortality [Срок оценки: Within 30 days after randomization]
• Length of hospital stay [Срок оценки: From date of admission to date of discharge]
• Requirement for blood transfusion [Срок оценки: Within 30 days after randomization]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Patients with coronary heart disease receiving antiplatelet therapy
• Patients who can tolerate general anesthesia and endoscopy after anesthesia evaluation
• Voluntary participation in the clinical trial and signed informed consent

Критерии исключения

• Patients with unstable vital signs despite fluid resuscitation, blood transfusion, and other supportive treatments
• Presence of contraindications to endoscopy
• Patients with confirmed or suspected variceal upper gastrointestinal bleeding
• Gastrointestinal bleeding suspected to originate from the middle or lower gastrointestinal tract

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07507162 · 2025AZC2007

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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