Acute Non-variceal Upper Gastrointestinal Hemorrhage, Coronary Heart Disease
Conditions
Brief summary
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.
Interventions
PROCEDUREUrgent 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.
PROCEDUREEarly 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.
Sponsors
Beijing Anzhen Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| major adverse cardiovascular events (MACE) | Within 30 days after randomization | Incidence of MACE in the two groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Further bleeding | Within 7 days after randomization | To compare the rate of further bleeding between the two groups |
| All-cause mortality | Within 30 days after randomization | To compare all-cause mortality between the two groups. |
| Length of hospital stay | From date of admission to date of discharge | To compare the length of hospital stay between the two groups. |
| Requirement for blood transfusion | Within 30 days after randomization | Proportion of patients requiring blood transfusion. |
Contacts
CONTACTXue Chen, MD
STUDY_CHAIRXue Chen, MD
Beijing Anzhen Hospital
Outcome results
None listed