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

NCT07507162 | Not Yet Recruiting

• 1 other identifier: 2025AZC2007
• Study Type: interventional
• Target: 212
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Non-variceal Upper Gastrointestinal Hemorrhage; Coronary Heart Disease

Outcome Measures

Primary Outcomes (1)

• major adverse cardiovascular events (MACE)

  Incidence of MACE in the two groups

  Within 30 days after randomization

Secondary Outcomes (4)

• Further bleeding

  Within 7 days after randomization

• All-cause mortality

  Within 30 days after randomization

• Length of hospital stay

  From date of admission to date of discharge

• Requirement for blood transfusion

  Within 30 days after randomization

Study Arms (2)

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.

Procedure: Urgent Endoscopy (Within 12 Hours of Admission)

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.

Procedure: Early Endoscopy (12-24 Hours After Admission)

Interventions

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.

Urgent Endoscopy Group

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.

Early Endoscopy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Xue Chen, MD

  Beijing Anzhen Hospital

  STUDY CHAIR

Central Study Contacts

Xue Chen, MD

CONTACT

+86-15010049359; cx19890110@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: April 2, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share