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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Urgent Endoscopy Group | Experimental | Patients will undergo urgent endoscopy within 12 hours of hospital admission. All patients will receive standard medical treatment for acute non-variceal upper gastrointestinal bleeding and antiplatelet management in accordance with clinical guidelines. |
|
| Early Endoscopy Group | Experimental | Patients will undergo early endoscopy between 12 and 24 hours after hospital admission. All patients will receive standard medical treatment for acute non-variceal upper gastrointestinal bleeding and antiplatelet management in accordance with clinical guidelines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urgent Endoscopy (Within 12 Hours of Admission) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| major adverse cardiovascular events (MACE) | Incidence of MACE in the two groups | Within 30 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Further bleeding | To compare the rate of further bleeding between the two groups | Within 7 days after randomization |
| All-cause mortality | To compare all-cause mortality between the two groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xue Chen, MD | Contact | +86-15010049359 | cx19890110@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xue Chen, MD | Beijing Anzhen Hospital | Study Chair |
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| Early Endoscopy (12-24 Hours After Admission) | Procedure | 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. |
|
| Within 30 days after randomization |
| Length of hospital stay | To compare the length of hospital stay between the two groups. | From date of admission to date of discharge |
| Requirement for blood transfusion | Proportion of patients requiring blood transfusion. | Within 30 days after randomization |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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