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Could a Two-Week pill combo replace six months of acid blockers for heart patients?

NCT ID NCT04728516

Disease control Sponsor: Qilu Hospital of Shandong University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study looks at 2,600 heart attack patients who had a stent placed and also have an H. pylori infection. Half will get a 2-week course of vonoprazan plus amoxicillin to treat the infection, while the other half gets a standard 6-month acid blocker (pantoprazole). The goal is to see if the short treatment prevents stomach bleeding just as well as the long-term medication.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vonoprazan and amoxicillin
What this could lead to
If successful, this could offer a shorter, simpler treatment to prevent stomach bleeding in heart patients with H. pylori infection, reducing the need for long-term acid-suppressing drugs.
What could go wrong
This is a Phase 4 trial, but it is open-label (not blinded), which can bias results. The 2-week therapy may not be as effective as the standard 6-month PPI, and side effects from antibiotics are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 2,600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients with ACS and PCI treatment and postoperative DAPT ≥ 6 months; 2. Hp infection is positive; 3. Age ≥18 years old; 4. The patient himself or his authorized client signs the subject's consent. Exclusion Criteria: 1. Previous history of gastrointestinal ulcer bleeding; 2. Long-term use of PPI and H2 receptor inhibitors in the past; 3. Complicated with gastroesophageal varices, or after gastrectomy; 4. Those who are taking anti-coagulation drugs such as vitamin K antagonists (warfarin) ,factor X or factor II inhibitors; 5. Recently received fibrinolytic therapy (using fibrin-specific drugs within 24 hours before randomization, or using non-fibrin-specific drugs within 48 hours before randomization); 6. Recently accepted (within 30 days before randomization) or planned to undergo coronary artery bypass grafting (CABG); 7. Combining active bleeding or coagulation dysfunction (indicator); 8. 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; 9. Complicated with hemorrhagic stroke, intracranial tumor, arteriovenous malformation or aneurysm; 10. 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); 11. Systemic glucocorticoid application; 12. Have taken antibiotics and other drugs that affect the flora in the stomach within the past month; 13. A history of allergy to aspirin, clopidogrel, ticagrelor, pantoprazole, penicillin and other test drugs; 14. Pregnancy or breastfeeding women and subjects of childbearing age who do not want to take contraceptive measures; 15. With malignant tumors and other diseases, the expected survival time is less than 1 year; 16. Patients who participated in clinical trials of other drugs or are participating in clinical studies of other new drugs within 30 days before enrollment; 17. Complicated with mental illness or severe neurosis; 18. Can't express subjective discomfort symptoms; 19. The investigator decides that it is not suitable to participate in this research.

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Conditions

The condition(s) this trial relates to.

acute coronary syndrome Helicobacter pylori infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute coronary syndrome Helicobacter pylori infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    34 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Hospital of Shandong Second Medical University

    RECRUITING

    Weifang, Shandong, 261031, China

  • Affiliated Hospital of Shandong University of Traditional Chinese Medicine

    RECRUITING

    Jinan, Shandong, 250011, China

  • Aviation General Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100012, China

  • Bozhou People's Hospital

    RECRUITING

    Bozhou, Anhui, 236800, China

  • Central Hospital Affiliated to Shandong First medical University

    WITHDRAWN

    Jinan, Shandong, China

  • China-Japan Friendship Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100029, China

  • Chuzhou First People's Hospital

    RECRUITING

    Chuzhou, Anhui, 239000, China

  • Dongying People's Hospital

    RECRUITING

    Dongying, Shandong, 257091, China

  • Haiyang People's Hospital

    RECRUITING

    Yantai, Shandong, 256100, China

  • Heze Municipal Hospital

    RECRUITING

    Heze, Shandong, 274031, China

  • Hospital of Chengdu University of Traditional Chinese Medicine

    WITHDRAWN

    Chengdu, Sichuan, 610072, China

  • JINA CITY People's Hospital

    RECRUITING

    Jinan, Shandong, 271199, China

  • Liaocheng People's Hospital

    NOT_YET_RECRUITING

    Liaocheng, Shandong, 252000, China

  • Linshu County People'S Hospital

    RECRUITING

    Linyi, Shandong, 276700, China

  • Linyi City People's Hospital

    NOT_YET_RECRUITING

    Linyi, Shandong, 276000, China

  • NINGJIN People's Hospital

    RECRUITING

    Dezhou, Shandong, 253400, China

  • Pingyuan First People'S Hospital

    RECRUITING

    Dezhou, Shandong, 253100, China

  • Qilu Hospital of Shandong University

    NOT_YET_RECRUITING

    Jinan, Shandong, 250012, China

  • Qilu Hospital of Shandong University (Qingdao)

    NOT_YET_RECRUITING

    Qingdao, Shandong, 266000, China

  • Qilu Hospital of Shandong University Dezhou Hospital

    RECRUITING

    Dezhou, Shandong, 253000, China

  • Qinghai Red Cross Hospital

    RECRUITING

    Xining, Qinghai, 810000, China

  • Ru Shan People's Hospital

    RECRUITING

    Rushan, Yantai, 264500, China

  • Shandong Healthcare Group Zaozhuang Central Hospital

    WITHDRAWN

    Zaozhuang, Shandong, 277000, China

  • Shandong Provincial Third Hospital

    RECRUITING

    Jinan, Shandong, 250031, China

  • Shandong Public Health Clinical Center

    RECRUITING

    Jinan, Shandong, 250100, China

  • Shandong Second Provincial General Hospital

    WITHDRAWN

    Jinan, Shandong, 250002, China

  • THE Second People's Hospital of Dongying

    RECRUITING

    Dongying, Shandong, 257335, China

  • The 960th Hospital of the Joint Logistic Support Force

    WITHDRAWN

    Jinan, Shandong, 250000, China

  • The Affiliated Hospital of Qingdao University

    RECRUITING

    Qingdao, Shandong, 266003, China

  • The First Affiliated Hospital of Anhui Medical University

    NOT_YET_RECRUITING

    Hefei, Anhui, 230000, China

  • The First Affiliated Hospital of Dalian Medical University

    RECRUITING

    Dalian, Liaoning, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, 450052, China

  • The First People'S Hospital of Zunyi

    RECRUITING

    Zunyi, Guizhou, 563000, China

  • The First People's Hospital of Jining City

    NOT_YET_RECRUITING

    Jining, Shandong, 272000, China

  • The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, 200000, China

  • The fourth People's Hospital of jinan

    RECRUITING

    Jinan, Shandong, 250031, China

  • Tianjin Chest Hospital

    WITHDRAWN

    Tianjin, Tianjin Municipality, 300222, China

  • Weifang Hospital of Traditional Chinese Medicine

    RECRUITING

    Weifang, Shandong, 261041, China

  • Weihai Central Hospital

    WITHDRAWN

    Weihai, Shandong, 264200, China

  • Weihai Municipal Hospital

    NOT_YET_RECRUITING

    Weihai, Shandong, 264200, China

  • Zaozhuang Municipal Hospital

    RECRUITING

    Zaozhuang, Shandong, 277100, China

  • Zibo Central Hospital

    WITHDRAWN

    Zibo, Shandong, 255000, China

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