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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Heart Disease; Acute Non-variceal Upper Gastrointestinal Hemorrhage
• Intervention / Treatment: Procedure: Urgent Endoscopy (Within 12 Hours of Admission); Procedure: Early Endoscopy (12-24 Hours After Admission)

• Study Type: Interventional
• Enrollment (Estimated): 212
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xue Chen, MD; Phone Number: +86-15010049359; Email: cx19890110@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Urgent Endoscopy Group; 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); 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.
Experimental: Early Endoscopy Group; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
major adverse cardiovascular events (MACE)	Incidence of MACE in the two groups	Within 30 days after randomization

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital
• Investigators: Study Chair: Xue Chen, MD, Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: March 23, 2026
• First Submitted That Met QC Criteria: March 30, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 2025AZC2007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No