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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Anzhen Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Urgent Endoscopy (Within 12 Hours of Admission)

    Procedure/Surgery

    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.

  • Early Endoscopy (12-24 Hours After Admission)

    Procedure/Surgery

    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.

Treatment groups

212 Participants
are divided into 2 treatment groups
Group A: Urgent Endoscopy GroupExperimental treatment 1 intervention
Group B: Early Endoscopy GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

major adverse cardiovascular events (MACE)

Incidence of MACE in the two groups

Time frame
Within 30 days after randomization

Secondary outcomes

1

Further bleeding

To compare the rate of further bleeding between the two groups

Time frame
Within 7 days after randomization
2

All-cause mortality

To compare all-cause mortality between the two groups.

Time frame
Within 30 days after randomization
3

Length of hospital stay

To compare the length of hospital stay between the two groups.

Time frame
From date of admission to date of discharge
4

Requirement for blood transfusion

Proportion of patients requiring blood transfusion.

Time frame
Within 30 days after randomization

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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