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

NCT07487142 | Completed Phase 3

• 1 other identifier: H pylori eradication PCI
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

H Pylori Infection

Outcome Measures

Primary Outcomes (1)

• 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

  6months

Study Arms (3)

H pylori negative

NO INTERVENTION

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

Drug: BISMUTH TETRACYCLINE METRONIDAZOLE OMEPRAZOLE

H pylori positive no treatment

NO INTERVENTION

Interventions

BISMUTH TETRACYCLINE METRONIDAZOLE OMEPRAZOLE DRUG

PCI patients h pylori positive

H pylori positive received treatment

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Banī Suwayf

Banī Suwayf, Egypt

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: March 7, 2026
• First Posted: March 23, 2026
• Study Start: June 10, 2024
• Primary Completion: December 24, 2025
• Study Completion: December 24, 2025
• Last Updated: March 23, 2026

Record last verified: 2026-02

Locations

EG (1)