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NCT Number: NCT07507162

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.

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Key information

Conditions

Acute Non-variceal Upper Gastrointestinal Hemorrhage Cardiovascular Diseases Coronary Disease Coronary Heart Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. major adverse cardiovascular events (MACE)

    Time frame: Within 30 days after randomization

    Incidence of MACE in the two groups

Secondary outcomes

  1. Further bleeding

    Time frame: Within 7 days after randomization

    To compare the rate of further bleeding between the two groups

  2. All-cause mortality

    Time frame: Within 30 days after randomization

    To compare all-cause mortality between the two groups.

  3. Length of hospital stay

    Time frame: From date of admission to date of discharge

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

  4. Requirement for blood transfusion

    Time frame: Within 30 days after randomization

    Proportion of patients requiring blood transfusion.

Study contacts

Contact information is provided by the study sponsor or research team.

Xue Chen, MD

CONTACT

[email protected]

+86-15010049359

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Registry information

Official study 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

Acronym: PACT-UGIB

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Apr 2, 2026
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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