Effectiveness of the Eradication of Helicobacter Pylori and an Inhibitor of Pump With Proton Versus Control (Aspylori)

Comparative Effectiveness of the Eradication of Helicobacter Pylori and an Inhibitor of Pump With Proton Versus Control on the Gastric Lesions Induced by the Aspirin With the Low Dose Among Patients Treated With the Long Course

Low dose of aspirin is the main cause of gastro-duodenal ulcer. The best prevention is not definite particularly in patients without history of ulcer and infected by H. pylori.The aim of the study is to evaluate the gastric damage induced by aspirin in patients with H. pylori infection but who have any history of ulcer.

Study Overview

• Status: Withdrawn
• Conditions: Coronary Thrombosis; Positive Helicobacter Pylori Serology; Supra-aortic Artery Thrombosis
• Intervention / Treatment: Drug: during one week for the active treatments; Drug: Pantoprazole; Drug: Placebo Formula 515

Detailed Description

The aim of the study is to compare the protective effect of H. pylori eradication versus Pantoprazole versus placebo on the gastric damage induced by low dose of aspirin. Treatment are attributed by randomisation. Patients are followed for 6 months and gastric damage are evaluated by endoscopy at the end of this period.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Paris, France, 75181
    • Hotel Dieu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients of more than 18 years old
• Coronarography or coronary imaging or supra-aortic arterial trunks ultrasound examination performed since less 7 months and having at least an arterial vascular stenosis
• Indication for aspirin treatment for at least 12 months (at the moment of the visit of inclusion) at a posology from 80 to 125 mg per day. The treatment must be prescribed since less than 7 months.
• Patient who had since less 7 month a positive Helicobacter Pylori serology.
• For the women in age to procreate, effective mode of contraception (oral contraception, surgical sterilization, coil)
• Patient having given an informed consent according to recommendation of the CPP (institutional ethical committee).

Exclusion Criteria:

• treatment by anti-coagulant, whatever its nature and its posology, by proton pump inhibitor, H2 receptor antagonists or antiacid having to be continued beyond the day of inclusion
• Treatment by methotrexate in progress or stopped since less 3 months.
• Time of more 7 months enters the beginning of the treatment by aspirin and the visit of inclusion
• Treatment by NSAID (even occasional or self medication) under or stopped since less 3 months.
• Treatment by anti-platelet drug (clopidogrel, ticlopidine, flurbiprofen, dipyridamole or antagonist of receptor GPIIb/IIIa) in progress or stopped since less than 10 days.
• Patient with a serious pathology compromising survival in the 6 month to come.
• Patient with renal or respiratory insufficiency or a hepatic pathology having a clinical repercussion.
• History of surgery of esophagus, stomach or duodenum.
• History of digestive tract bleeding or gastro-duodenal ulcer or esophagal ulcerating proven by endoscopy.
• Allergy known to clarithromycin.
• Psychiatric disorder not controlled by treatment.
• Patients all ready include in a therapeutic protocol or to be followed for 6 month.
• Alcohol consumption higher than 100gr. per day.
• Patient non suitable for participating in the protocol or to be followed for 6 month.
• History of intolerance to salicylate.
• Constitutional or acquired hemorrhagic disease
• Pregnant woman or nursing.
• Patient in emergency, people hospitalized without their assent, people without freedom, people without social health insurance.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: C; Placebo	Drug: Placebo Formula 515; 26 weeks, one tablet per day
Active Comparator: A; Amoxicillin, Clarythromycin or metronidazole,Pantoprazole,Placebo	Drug: during one week for the active treatments; during one week for the active treatments placebo during 25 weeks; Other Names: Placebo; Amoxicillin; Pantoprazole; Clarythromycin or metronidazole
Experimental: B; Pantoprazole	Drug: Pantoprazole; 6 months at 20 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measure: severity of the ulcerated gastric lesions induced by the aspirin	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
To measure: percentage of patients having had at least an ulcer	6 months
To measure: the average of the ranks of lesion in antrum and corpus.	6 months
To measure percentage of patients having had digestive clinical events	6 months
To measure: the average of the ranks of severity of the hemorrhagic lesions and erosive lesions evaluated in antrum and corpus by two analogical scales of 150 mm	6 months
To measure Percentage of patients having a hemorrhagic digestive of clinical expression or detected by the biological tests.	6 months
To measure : Elements of the histopathologic score of Sydney	6 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Dominique Lamarque, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: June 18, 2008
• First Submitted That Met QC Criteria: July 11, 2008
• First Posted (Estimate): July 14, 2008

Study Record Updates

• Last Update Posted (Estimate): April 21, 2015
• Last Update Submitted That Met QC Criteria: April 20, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Helicobacter pylori; Gastric lesions induced by low dose of aspirin
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Coronary Disease; Thrombosis; Coronary Thrombosis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Metronidazole; Amoxicillin; Clarithromycin; Pantoprazole
• Other Study ID Numbers: P051021; AOM 05114