Prevalence of Asymptomatic H Pylori Infection Among Patients Undergoing PCI and Impact of Its Eradication on Occurrence of GIT Symptoms and Bleeding"

March 17, 2026 updated by: Rania Abdelaaty, Beni-Suef University

"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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Banī Suwayf, Egypt
        • Banī Suwayf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: H pylori negative
Active Comparator: H pylori positive received treatment
  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
Drug: BISMUTH TETRACYCLINE METRONIDAZOLE OMEPRAZOLE
PCI patients h pylori positive
No Intervention: H pylori positive no treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2024

Primary Completion (Actual)

December 24, 2025

Study Completion (Actual)

December 24, 2025

Study Registration Dates

First Submitted

March 7, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 23, 2026

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • H pylori eradication PCI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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