H Pylori InfectionPhase 3NCT07487142
Prevalence of Asymptomatic H Pylori Infection Among Patients Undergoing PCI and Impact of Its Eradication on Occurrence of GIT Symptoms and Bleeding"
A Phase 3 study testing BISMUTH TETRACYCLINE METRONIDAZOLE OMEPRAZOLE in people with H Pylori Infection, run by Beni-Suef University at 1 site in Egypt.
Trial summary
In the present study, the aim was to report the prevalence of positive H. pylori infection in an unselected population referred for coronary intervention and likely to required DAPT or DPI, also the study assessed impact of H. pylori eradication on occurrence of GI symptoms or bleeding during the follow up period. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- H Pylori Infection
- What is being tested?
- BISMUTH TETRACYCLINE METRONIDAZOLE OMEPRAZOLE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2024to 24 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ischemic heart disease patients scheduled for percutaneous coronary intervention
- divided according to positivity of H. pylori infection,without restriction as regard the acuity of the clinical presentation (unstable angina,NSTEMI, STEMI, and elective procedures included).
- H pylori positive patient were subdivided according to eradication therapy intake
Who cannot join
- Patients without the possibility of requiring DAPT or DPI post-procedure, such as those referred for diagnostic hemodynamic studies only, cardiac biopsy, or diagnostic angiography in anticipation of a surgical valve procedure, we excluded.
- Patients with known gastrointestinal symptoms (e.g. Dyspepsia and vomiting),gastrointestinal bleeding(e.g.Heamtemesis and melena),Known to halve chronic gastritis, peptic ulcer or had upper GI endoscopy before or those who were diagnosed previously as H.pylori positive patients or received eradication therapy before
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Prevalence of Asymptomatic Helicobacter Pylori Infection Among Patients Undergoing Percutaneous Coronary Intervention and Impact of Its Eradication on Occurrence of Gastrointestinal Symptoms and Bleeding"
In the present study, the aim was to report the prevalence of positive H. pylori infection in an unselected population referred for coronary intervention and likely to required DAPT or DPI, also the study assessed impact of H. pylori eradication on occurrence of GI symptoms or bleeding during the follow up period.
- Conditions
- H Pylori Infection
- Being tested
- BISMUTH TETRACYCLINE METRONIDAZOLE OMEPRAZOLE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BISMUTH TETRACYCLINE METRONIDAZOLE OMEPRAZOLEDrug
PCI patients h pylori positive
| Study group | Role | What they receive |
|---|---|---|
| H pylori negative | No intervention | Not described |
| H pylori positive received treatment | Active comparator | 1. PPI or H2 receptor antagonist (eg, lansoprazole 30 mg BID or famotidine20 mg BID ) plus
2. Bismuth subsalicylate 525 mg QID (or bismuth tripotassium dicitrate 300 mg QID ) plus
3. Metronidazole 250 mg QID or 500 mg TID (or levofloxacin 500 mg QD) plus
4. Tetracycline 500 mg QID Receives: Drug: BISMUTH TETRACYCLINE METRONIDAZOLE OMEPRAZOLE |
| H pylori positive no treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
GIT symptoms
We used a common Questionnaire for assessment of GIT symptoms and grading of its severity called(Evaluation of a Gastrointestinal Symptoms Questionnaire)
Every symptom was assessed as regard it's duration,time of it's occurrence e.g. post prandial,daytime or nighttime and severity either none,mild,moderate,severe,very severe and unbearable Link of the questionnaire is attached https://www.researchgate.net/publication/6861419_Evaluation_of_a_Gastrointestinal_Symptoms_Questionnaire
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start10 Jun 2024
- Primary completion24 Dec 2025
- Study completion24 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for H Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Abdelaaty, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487142
- Sponsor's protocol ID
- H pylori eradication PCI
- Status last verified
- Feb 2026
- First submitted
- 7 Mar 2026
- Last updated
- 23 Mar 2026
- 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 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Prevalence of Asymptomatic Helicobacter Pylori Infection Among Patients Undergoing Percutaneous Coronary Intervention and Impact of Its Eradication on Occurrence of Gastrointestinal Symptoms and Bleeding"
- ClinicalTrials.gov ID
- NCT07487142
- Acronym / sponsor ID
- H pylori eradication PCI
- Conditions
- H Pylori Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 24 Dec 2025 (actual)
- Study completion
- 24 Dec 2025 (actual)
- First posted
- 23 Mar 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.
In the present study, the aim was to report the prevalence of positive H. pylori infection in an unselected population referred for coronary intervention and likely to required DAPT or DPI, also the study assessed impact of H. pylori eradication on occurrence of GI symptoms or bleeding during the follow up period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| H pylori negative | No intervention | – |
| H pylori positive received treatment | Active comparator | Drug: BISMUTH TETRACYCLINE METRONIDAZOLE OMEPRAZOLE1. PPI or H2 receptor antagonist (eg, lansoprazole 30 mg BID or famotidine20 mg BID ) plus 2. Bismuth subsalicylate 525 mg QID (or bismuth tripotassium dicitrate 300 mg QID ) plus 3. Metronidazole 250 mg QID or 500 mg TID (or levofloxacin 500 mg QD) plus 4. Tetracycline 500 mg QID |
| H pylori positive no treatment | No intervention | – |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ischemic heart disease patients scheduled for percutaneous coronary intervention
- divided according to positivity of H. pylori infection,without restriction as regard the acuity of the clinical presentation (unstable angina,NSTEMI, STEMI, and elective procedures included).
- H pylori positive patient were subdivided according to eradication therapy intake
Key exclusion criteria (2 listed)
- Patients without the possibility of requiring DAPT or DPI post-procedure, such as those referred for diagnostic hemodynamic studies only, cardiac biopsy, or diagnostic angiography in anticipation of a surgical valve procedure, we excluded.
- Patients with known gastrointestinal symptoms (e.g. Dyspepsia and vomiting),gastrointestinal bleeding(e.g.Heamtemesis and melena),Known to halve chronic gastritis, peptic ulcer or had upper GI endoscopy before or those who were diagnosed previously as H.pylori positive patients or received eradication therapy before
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 |
|---|---|---|
| BISMUTH TETRACYCLINE METRONIDAZOLE OMEPRAZOLEPCI patients h pylori positive | Drug | H pylori positive received treatment |
Primary outcome
GIT symptoms
Time frame: 6months
We used a common Questionnaire for assessment of GIT symptoms and grading of its severity called(Evaluation of a Gastrointestinal Symptoms Questionnaire) Every symptom was assessed as regard it's duration,time of it's occurrence e.g. post prandial,daytime or nighttime and severity either none,mild,moderate,severe,very severe and unbearable Link of the questionnaire is attached https://www.researchgate.net/publication/6861419_Evaluation_of_a_Gastrointestinal_Symptoms_Questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BISMUTH TETRACYCLINE METRONIDAZOLE OMEPRAZOLE in people with H Pylori Infection, run by Beni-Suef University at 1 site in Egypt.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GIT symptoms (time frame: 6months). 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 23 Mar 2026.