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Not yet recruiting NCT07507162

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

No phase Interventional Acute Non-variceal Upper Gastrointestinal Hemorrhage Coronary Heart Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Urgent Endoscopy (Within 12 Hours of Admission), Early Endoscopy (12-24 Hours After Admission).
Who it may be relevant to
Registry conditions: Acute Non-variceal Upper Gastrointestinal Hemorrhage, Coronary Heart Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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.
  • 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.

Primary outcome measures

  • major adverse cardiovascular events (MACE) [Time frame: Within 30 days after randomization]
Secondary outcome measures (4)
  • Further bleeding [Time frame: Within 7 days after randomization]
  • All-cause mortality [Time frame: Within 30 days after randomization]
  • Length of hospital stay [Time frame: From date of admission to date of discharge]
  • Requirement for blood transfusion [Time frame: Within 30 days after randomization]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07507162 · 2025AZC2007

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗