Acute Coronary SyndromePhase 4NCT04728516
The Effect of Dual Eradication Therapy vs PPI on Gastrointestinal Bleeding in ACS Patients
A Phase 4 study testing Vonoprazan-based dual eradication therapy for two weeks, amoxicillin and Pantoprazole in people with Acute Coronary Syndrome and Helicobacter Pylori Infection, run by Qilu Hospital of Shandong University at 42 sites in China.
Trial summary
Patients with acute coronary syndrome (ACS) after Percutaneous Coronary Intervention (PCI) require routine treatment with dual antiplatelet (DAPT) treatment, but with the high risk of bleeding, gastrointestinal bleeding is the most common type of major bleeding. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Helicobacter Pylori Infection
- What is being tested?
- Vonoprazan-based dual eradication therapy for two weeks, amoxicillin and Pantoprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,600 participants
- Where
- 42 sitesChina
- Study dates
- 12 Apr 2023to 30 Jun 2026
- Phase
- Phase 4
- 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
- Patients with ACS and PCI treatment and postoperative DAPT ≥ 6 months;
- Hp infection is positive;
- Age ≥18 years old;
- The patient himself or his authorized client signs the subject's consent.
Who cannot join
- Previous history of gastrointestinal ulcer bleeding;
- Long-term use of PPI and H2 receptor inhibitors in the past;
- Complicated with gastroesophageal varices, or after gastrectomy;
- Those who are taking anti-coagulation drugs such as vitamin K antagonists (warfarin) ,factor X or factor II inhibitors;
- Recently received fibrinolytic therapy (using fibrin-specific drugs within 24 hours before randomization, or using non-fibrin-specific drugs within 48 hours before randomization);
- Recently accepted (within 30 days before randomization) or planned to undergo coronary artery bypass grafting (CABG);
Show all 19Show fewer
- Combining active bleeding or coagulation dysfunction (indicator);
- In patients with liver and kidney disease, serum creatinine is greater than 150 μmol/L, GFR <60ml/min/1.73m2, alanine aminotransferase and aspartate aminotransferase increase ≥3 times from the normal value;
- Complicated with hemorrhagic stroke, intracranial tumor, arteriovenous malformation or aneurysm;
- Anemia (adult male hemoglobin less than 120 g/L or red blood cells less than 4×10^12/L,adult female hemoglobin less than 105 g/L or red blood cells less than 3.5×10^12/L);
- Systemic glucocorticoid application;
- Have taken antibiotics and other drugs that affect the flora in the stomach within the past month;
- A history of allergy to aspirin, clopidogrel, ticagrelor, pantoprazole, penicillin and other test drugs;
- Pregnancy or breastfeeding women and subjects of childbearing age who do not want to take contraceptive measures;
- With malignant tumors and other diseases, the expected survival time is less than 1 year;
- Patients who participated in clinical trials of other drugs or are participating in clinical studies of other new drugs within 30 days before enrollment;
- Complicated with mental illness or severe neurosis;
- Can't express subjective discomfort symptoms;
- The investigator decides that it is not suitable to participate in this research.
Trial locations and contacts
42 sites in 1 country. Contact the study team or a site near you to ask about taking part.
42 sites in 1 country
China42 sites, 34 recruiting
- Recruiting
Aviation General Hospital
Beijing, Beijing Municipality, 100012
Yanfu Wang
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Mingjing Shao
- Recruiting
Bozhou People's Hospital
Bozhou, Anhui, 236800
Duoxue Chen
- Withdrawn
Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, 610072
- Recruiting
Chuzhou First People's Hospital
Chuzhou, Anhui, 239000
Tongtong Shen
- Recruiting
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning
Junjie Wang
- Recruiting
Qilu Hospital of Shandong University Dezhou Hospital
Dezhou, Shandong, 253000
Hongwei Dong
- Recruiting
Pingyuan First People'S Hospital
Dezhou, Shandong, 253100
Xia Li
- Recruiting
NINGJIN People's Hospital
Dezhou, Shandong, 253400
Tao Zhang
- Recruiting
Dongying People's Hospital
Dongying, Shandong, 257091
Xiaotian Wang
- Recruiting
THE Second People's Hospital of Dongying
Dongying, Shandong, 257335
Tianjin Gu
- Not yet recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230000
xianhe lin
- Recruiting
Heze Municipal Hospital
Heze, Shandong, 274031
Ke Liang
- Withdrawn
The 960th Hospital of the Joint Logistic Support Force
Jinan, Shandong, 250000
- Withdrawn
Shandong Second Provincial General Hospital
Jinan, Shandong, 250002
- Recruiting
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, 250011
Zhen Wang
- Not yet recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
YUGUO CHEN
- Recruiting
Shandong Provincial Third Hospital
Jinan, Shandong, 250031
Guo Zhou
- Recruiting
The fourth People's Hospital of jinan
Jinan, Shandong, 250031
Qiang Liu
- Recruiting
Shandong Public Health Clinical Center
Jinan, Shandong, 250100
Xiaojuan Zhang
- Recruiting
JINA CITY People's Hospital
Jinan, Shandong, 271199
Zengtang Zhang
- Withdrawn
Central Hospital Affiliated to Shandong First medical University
Jinan, Shandong
- Not yet recruiting
The First People's Hospital of Jining City
Jining, Shandong, 272000
shuyin sun
- Not yet recruiting
Liaocheng People's Hospital
Liaocheng, Shandong, 252000
yuzeng xue
- Not yet recruiting
Linyi City People's Hospital
Linyi, Shandong, 276000
yanjin wei
- Recruiting
Linshu County People'S Hospital
Linyi, Shandong, 276700
Xiaozhou Wang
- Not yet recruiting
Qilu Hospital of Shandong University (Qingdao)
Qingdao, Shandong, 266000
beian you
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003
Peng Li
- Recruiting
Ru Shan People's Hospital
Rushan, Yantai, 264500
Lei Dong
- Not yet recruiting
The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200000
changqian wang
- Withdrawn
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300222
- Recruiting
Affiliated Hospital of Shandong Second Medical University
Weifang, Shandong, 261031
Luchang Yin
- Recruiting
Weifang Hospital of Traditional Chinese Medicine
Weifang, Shandong, 261041
Qinwei Zhu
- Withdrawn
Weihai Central Hospital
Weihai, Shandong, 264200
- Not yet recruiting
Weihai Municipal Hospital
Weihai, Shandong, 264200
xinfu zhou
- Recruiting
Qinghai Red Cross Hospital
Xining, Qinghai, 810000
Jiuping Zhao
- Recruiting
Haiyang People's Hospital
Yantai, Shandong, 256100
Xuguang Liu
- Withdrawn
Shandong Healthcare Group Zaozhuang Central Hospital
Zaozhuang, Shandong, 277000
- Recruiting
Zaozhuang Municipal Hospital
Zaozhuang, Shandong, 277100
Jun Yang
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Junhui Xing
- Withdrawn
Zibo Central Hospital
Zibo, Shandong, 255000
- Recruiting
The First People'S Hospital of Zunyi
Zunyi, Guizhou, 563000
Xiaochuan Bai
About this study
Official title: The Effect of Vonoprazan-based Dual Eradication Therapy vs PPI Treatment on Gastrointestinal Bleeding in ACS Patients With Hp Infection and Coronary Stents: an Open-label, Randomized, Controlled Trial
Patients with acute coronary syndrome (ACS) after Percutaneous Coronary Intervention (PCI) require routine treatment with dual antiplatelet (DAPT) treatment, but with the high risk of bleeding, gastrointestinal bleeding is the most common type of major bleeding. Helicobacter pylori (Hp) infection is a high-risk factor for gastrointestinal bleeding, with an incidence of about 50%. Foreign authoritative DAPT guidelines do not give individual guidance to Hp-infected patients. It is recommended that those with high bleeding risk should be combined with proton pump inhibitors (PPI), but long-term compliance with PPI is not ideal. Authoritative experts in China have agreed to recommend Hp detection and eradication therapy for DAPT patients, but loss of evidence. Vonoprazan is a novel potassium ion competitive acid blocker, based on Vonoprazan's dual Hp eradication therapy is simple and effective. Our team will conduct a multi-center, open-label, randomized controlled clinical trial using a non-inferior design to compare the combination of Vonoprazan + amoxicillin combined with pantoprazole (PPI) for 6 months after PCI on the bleeding events of the digestive tract.
Read the detailed description
This study plans to enroll 2600 patients, 1300 patients in each group, in the project participating hospitals who received coronary stenting and are expected to undergo DAPT ≥6 months after operation. Hp13C-urea breath test and serum Hp antibody scores Type detection, patients with positive Hp infection.
Antiplatelet drugs (DAPT) use aspirin 100 mg qd, plus clopidogrel 75 mg qd or aspirin 100mg qd plus ticagrelor 90 mg bid. The specific medication is evaluated and decided by the interventional doctor.
After the subjects in each center signed a written informed consent form, they randomly divided each test case into a test group or a control group at a 1:1 ratio:
- Test group: In the project participating hospitals who received coronary stenting and are expected to undergo DAPT ≥6 months after operation. Hp13C-urea breath test and serum Hp antibody scores Type detection, patients with positive Hp infection. Antiplatelet drugs (DAPT) use aspirin 100 mg qd, plus clopidogrel 75 mg qd or aspirin 100 mg qd, plus ticagrelor 90 mg bid. The specific medication is evaluated and decided by the interventional doctor.
- pylori eradication using a dual eradication regimen, a course of 14 days, followed up to 6 months after randomization; the treatment regimen is as follows: routine use of Vonoprazan 20mg bid + amoxicillin 1g tid, a duration of 14 days(Considering the high drug resistance rate of Hp strains in China, we increase the course of eradication treatment to 14 days) .
- Introduce the subject to the possible adverse reactions to the dual eradication at the informed stage, and inform the subject that when the adverse reaction occurs, the researcher should be contacted as soon as possible to deal with it as soon as possible to reduce unnecessary shedding. For patients who are unable to tolerate the combination therapy and fall off, record the reason for the incomplete treatment and the corresponding time point, and continue the safety visit. ii. More than 1 month after completion of the dual eradication (scheduled at the 12th week of follow-up, visit 3), use the 13C-urea breath test to retest Hp infection. For subjects who failed H. pylori eradication, in the Department of Gastroenterology Remedial treatment under the guidance of a doctor.
- Control group:
In the project participating hospitals who received coronary stenting and are expected to undergo DAPT ≥ 6 months after operation. Hp13C-urea breath test and serum Hp antibody scores Type detection, patients with positive Hp infection. Antiplatelet drugs (DAPT) use aspirin 100 mg qd, plus clopidogrel 75 mg qd or aspirin 100 mg qd plus ticagrelor 90 mg bid. The specific medication is evaluated and decided by the interventional doctor. Taking pantoprazole 40 mg daily, followed up to 6 months after randomization.
- Being tested
- Vonoprazan-based dual eradication therapy for two weeks, amoxicillin, Pantoprazole
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vonoprazan-based dual eradication therapy for two weeksDrug
Patients with ACS after PCI, associated with positive Hp need a long-term DAPT treatment. We conducted a study on the prevention of gastrointestinal bleeding between vonoprazan-based dual eradication therapy for two weeks and pantoprazole for six months of a rountine therapy.
amoxicillinDrug
amoxicillin
PantoprazoleDrug
Pantoprazole
| Study group | Role | What they receive |
|---|---|---|
| Vonoprazan-based dual eradication therapy | Experimental | H. pylori eradication using a dual eradication regimen, a course of 14 days, followed up to 6 months after randomization; the treatment regimen is as follows: routine use of Vonoprazan 20mg bid + amoxicillin 1g tid, a course of 14 days . Receives: Drug: Vonoprazan-based dual eradication therapy for two weeks; Drug: amoxicillin |
| Pantoprazole | Active comparator | To take pantoprazole 40 mg daily, followed up to 6 months after randomization. Receives: Drug: Pantoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal bleeding of 6 months in patients with ACS after PCI
To compare the effects of the combination of vonoprazan + amoxicillin and pantoprazole on gastrointestinal bleeding events within 6 months in patients with ACS after PCI，The primary endpoint was gastrointestinal bleeding, including gastroduodenal bleeding, gastrointestinal bleeding with unknown bleeding site, and occult gastrointestinal bleeding.
Measured: 6 months
Secondary outcomes (2)
major adverse cardiovascular and cerebrovascular events (MACCE)
To compare the effects of the combination of vonoprazan + amoxicillin and pantoprazole on major adverse cardiovascular and cerebrovascular events (MACCE) within 6 months in patients with ACS after PCI. The secondary outcomes measure were MACCE , including :stent thrombosis, recurrent myocardial infarction, unplanned revascularization cardiogenic shock, stroke, cardiovascular death, and all-cause death.
Measured: 6 month
complex gastrointestinal event
To compare the effects of the combination of vonoprazan + amoxicillin and pantoprazole on complex gastrointestinal events. The secondary outcomes measure were complex gastrointestinal events, including upper gastrointestinal bleeding (BARC type), symptomatic gastroduodenal ulcer, gastroesophageal reflux, intestinal obstruction, gastrointestinal perforation, diarrhea, dyspepsia.
Measured: 6month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start12 Apr 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-guo Chen, MD, PhD, Study chair, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728516
- Sponsor's protocol ID
- 2020SDUCRCA006
- Status last verified
- Sep 2025
- First submitted
- 20 Jan 2021
- Last updated
- 16 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vonoprazan-based Dual Eradication Therapy vs PPI Treatment on Gastrointestinal Bleeding in ACS Patients With Hp Infection and Coronary Stents: an Open-label, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04728516
- Acronym / sponsor ID
- 2020SDUCRCA006
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,600 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 28 Jan 2021 (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.
Patients with acute coronary syndrome (ACS) after Percutaneous Coronary Intervention (PCI) require routine treatment with dual antiplatelet (DAPT) treatment, but with the high risk of bleeding, gastrointestinal bleeding is the most common type of major bleeding. Helicobacter pylori (Hp) infection is a high-risk factor for gastrointestinal bleeding, with an incidence of about 50%. Foreign authoritative DAPT guidelines do not give individual guidance to Hp-infected patients. It is recommended that those with high bleeding risk should be combined with proton pump inhibitors (PPI), but long-term compliance with PPI is not ideal. Authoritative experts in China have agreed to recommend Hp detection and eradication therapy for DAPT patients, but loss of evidence. Vonoprazan is a novel potassium ion competitive acid blocker, based on Vonoprazan's dual Hp eradication therapy is simple and effective. Our team will conduct a multi-center, open-label, randomized controlled clinical trial using a non-inferior design to compare the combination of Vonoprazan + amoxicillin combined with pantoprazole (PPI) for 6 months after PCI on the bleeding events of the digestive tract.
Detailed description
This study plans to enroll 2600 patients, 1300 patients in each group, in the project participating hospitals who received coronary stenting and are expected to undergo DAPT ≥6 months after operation. Hp13C-urea breath test and serum Hp antibody scores Type detection, patients with positive Hp infection.
Antiplatelet drugs (DAPT) use aspirin 100 mg qd, plus clopidogrel 75 mg qd or aspirin 100mg qd plus ticagrelor 90 mg bid. The specific medication is evaluated and decided by the interventional doctor.
After the subjects in each center signed a written informed consent form, they randomly divided each test case into a test group or a control group at a 1:1 ratio:
- Test group: In the project participating hospitals who received coronary stenting and are expected to undergo DAPT ≥6 months after operation. Hp13C-urea breath test and serum Hp antibody scores Type detection, patients with positive Hp infection. Antiplatelet drugs (DAPT) use aspirin 100 mg qd, plus clopidogrel 75 mg qd or aspirin 100 mg qd, plus ticagrelor 90 mg bid. The specific medication is evaluated and decided by the interventional doctor.
- pylori eradication using a dual eradication regimen, a course of 14 days, followed up to 6 months after randomization; the treatment regimen is as follows: routine use of Vonoprazan 20mg bid + amoxicillin 1g tid, a duration of 14 days(Considering the high drug resistance rate of Hp strains in China, we increase the course of eradication treatment to 14 days) .
- Introduce the subject to the possible adverse reactions to the dual eradication at the informed stage, and inform the subject that when the adverse reaction occurs, the researcher should be contacted as soon as possible to deal with it as soon as possible to reduce unnecessary shedding. For patients who are unable to tolerate the combination therapy and fall off, record the reason for the incomplete treatment and the corresponding time point, and continue the safety visit. ii. More than 1 month after completion of the dual eradication (scheduled at the 12th week of follow-up, visit 3), use the 13C-urea breath test to retest Hp infection. For subjects who failed H. pylori eradication, in the Department of Gastroenterology Remedial treatment under the guidance of a doctor.
- Control group:
In the project participating hospitals who received coronary stenting and are expected to undergo DAPT ≥ 6 months after operation. Hp13C-urea breath test and serum Hp antibody scores Type detection, patients with positive Hp infection. Antiplatelet drugs (DAPT) use aspirin 100 mg qd, plus clopidogrel 75 mg qd or aspirin 100 mg qd plus ticagrelor 90 mg bid. The specific medication is evaluated and decided by the interventional doctor. Taking pantoprazole 40 mg daily, followed up to 6 months after randomization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vonoprazan-based dual eradication therapy | Experimental | Drug: Vonoprazan-based dual eradication therapy for two weeks, Drug: amoxicillinH. pylori eradication using a dual eradication regimen, a course of 14 days, followed up to 6 months after randomization; the treatment regimen is as follows: routine use of Vonoprazan 20mg bid + amoxicillin 1g tid, a course of 14 days . |
| Pantoprazole | Active comparator | Drug: PantoprazoleTo take pantoprazole 40 mg daily, followed up to 6 months after randomization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with ACS and PCI treatment and postoperative DAPT ≥ 6 months;
- Hp infection is positive;
- Age ≥18 years old;
- The patient himself or his authorized client signs the subject's consent.
Key exclusion criteria (19 listed)
- Previous history of gastrointestinal ulcer bleeding;
- Long-term use of PPI and H2 receptor inhibitors in the past;
- Complicated with gastroesophageal varices, or after gastrectomy;
- Those who are taking anti-coagulation drugs such as vitamin K antagonists (warfarin) ,factor X or factor II inhibitors;
- Recently received fibrinolytic therapy (using fibrin-specific drugs within 24 hours before randomization, or using non-fibrin-specific drugs within 48 hours before randomization);
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 |
|---|---|---|
| Vonoprazan-based dual eradication therapy for two weeksPatients with ACS after PCI, associated with positive Hp need a long-term DAPT treatment. We conducted a study on the prevention of gastrointestinal bleeding between vonoprazan-based dual eradication therapy for two weeks and pantoprazole for six months of a rountine therapy. | Drug | Vonoprazan-based dual eradication therapy |
| amoxicillinamoxicillin | Drug | Vonoprazan-based dual eradication therapy |
| PantoprazolePantoprazole | Drug | Pantoprazole |
Primary outcome
Gastrointestinal bleeding of 6 months in patients with ACS after PCI
Time frame: 6 months
To compare the effects of the combination of vonoprazan + amoxicillin and pantoprazole on gastrointestinal bleeding events within 6 months in patients with ACS after PCI，The primary endpoint was gastrointestinal bleeding, including gastroduodenal bleeding, gastrointestinal bleeding with unknown bleeding site, and occult gastrointestinal bleeding.
2 secondary outcomes
major adverse cardiovascular and cerebrovascular events (MACCE)
Time frame: 6 month
complex gastrointestinal event
Time frame: 6month
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 16 Sep 2025.
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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.
Yu-guo Chen, MD, PhD study chair
Qilu Hospital of Shandong University
42 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vonoprazan-based dual eradication therapy for two weeks, amoxicillin and Pantoprazole in people with Acute Coronary Syndrome and Helicobacter Pylori Infection, run by Qilu Hospital of Shandong University at 42 sites in China.
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 19 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: looking for participants now, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yuan Bian, MD, PhD (+8618560083065, bianyuan@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal bleeding of 6 months in patients with ACS after PCI (time frame: 6 months). 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 16 Sep 2025.