Acute Non-variceal Upper Gastrointestinal HemorrhagePACT-UGIBNCT07507162
Timing of Endoscopy in Coronary Heart Disease Patients Taking Antiplatelet Drugs With Acute Non-variceal Upper Gastrointestinal Bleeding
A study testing Urgent Endoscopy (Within 12 Hours of Admission) and Early Endoscopy (12-24 Hours After Admission) in people with Acute Non-variceal Upper Gastrointestinal Hemorrhage and Coronary Heart Disease, run by Beijing Anzhen Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Non-variceal Upper Gastrointestinal Hemorrhage, Coronary Heart Disease
- What is being tested?
- Urgent Endoscopy (Within 12 Hours of Admission) and Early Endoscopy (12-24 Hours After Admission)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read more
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.
- Being tested
- Urgent Endoscopy (Within 12 Hours of Admission), Early Endoscopy (12-24 Hours After Admission)
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urgent Endoscopy (Within 12 Hours of Admission)Procedure or 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 or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Early Endoscopy (12-24 Hours After Admission) |
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse cardiovascular events (MACE)
Incidence of MACE in the two groups
Measured: Within 30 days after randomization
Secondary outcomes (4)
Further bleeding
To compare the rate of further bleeding between the two groups
Measured: Within 7 days after randomization
All-cause mortality
To compare all-cause mortality between the two groups.
Measured: Within 30 days after randomization
Length of hospital stay
To compare the length of hospital stay between the two groups.
Measured: From date of admission to date of discharge
Requirement for blood transfusion
Proportion of patients requiring blood transfusion.
Measured: Within 30 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Non-variceal Upper Gastrointestinal HemorrhageStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Xue, Beijing Anzhen Hospital
- Investigators
- Xue Chen, MD, Study chair, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507162
- Sponsor's protocol ID
- 2025AZC2007
- Acronym
- PACT-UGIB
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07507162
- Acronym / sponsor ID
- PACT-UGIB / 2025AZC2007
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urgent Endoscopy Group | Experimental | Procedure: Urgent Endoscopy (Within 12 Hours of Admission)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. |
| Early Endoscopy Group | Experimental | Procedure: Early Endoscopy (12-24 Hours After Admission)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Urgent Endoscopy Group |
| 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. | Procedure or surgery | Early Endoscopy Group |
Primary outcome
major adverse cardiovascular events (MACE)
Time frame: Within 30 days after randomization
Incidence of MACE in the two groups
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xue Chen, MD study chair
Beijing Anzhen Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Urgent Endoscopy (Within 12 Hours of Admission) and Early Endoscopy (12-24 Hours After Admission) in people with Acute Non-variceal Upper Gastrointestinal Hemorrhage and Coronary Heart Disease, run by Beijing Anzhen Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xue Chen, MD (+86-15010049359, cx19890110@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major adverse cardiovascular events (MACE) (time frame: Within 30 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.