About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Urgent Endoscopy (Within 12 Hours of Admission)
Procedure/SurgeryUrgent endoscopy performed within 12 hours after the patient is admitted to the hospital, used to diagnose and treat acute non-variceal upper gastrointestinal bleeding.
Early Endoscopy (12-24 Hours After Admission)
Procedure/SurgeryEarly 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.
Treatment groups
Trial outcomes
Primary outcomes
major adverse cardiovascular events (MACE)
Incidence of MACE in the two groups
Secondary outcomes
Further bleeding
To compare the rate of further bleeding between the two groups
All-cause mortality
To compare all-cause mortality between the two groups.
Length of hospital stay
To compare the length of hospital stay between the two groups.
Requirement for blood transfusion
Proportion of patients requiring blood transfusion.
Locations
Sponsors and contacts
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