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

NCT ID: NCT00713947

Last Updated: 2015-04-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2010-03-31

Brief Summary

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.

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.

Conditions

Positive Helicobacter Pylori Serology; Coronary Thrombosis; Supra-aortic Artery Thrombosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

A

Amoxicillin, Clarythromycin or metronidazole,Pantoprazole,Placebo

Group Type: ACTIVE_COMPARATOR

during one week for the active treatments

Intervention Type: DRUG

during one week for the active treatments placebo during 25 weeks

B

Pantoprazole

Group Type: EXPERIMENTAL

Pantoprazole

Intervention Type: DRUG

6 months at 20 mg

C

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo Formula 515

Intervention Type: DRUG

26 weeks, one tablet per day

Interventions

during one week for the active treatments

during one week for the active treatments placebo during 25 weeks

Intervention Type: DRUG

Pantoprazole

6 months at 20 mg

Intervention Type: DRUG

Placebo Formula 515

26 weeks, one tablet per day

Intervention Type: DRUG

Other Intervention Names

Amoxicillin; Clarythromycin or metronidazole; Pantoprazole; Placebo

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dominique Lamarque, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hotel Dieu Hospital

Paris, , France

Countries

France

Other Identifiers

AOM 05114

Identifier Type: -

Identifier Source: secondary_id

P051021

Identifier Type: -

Identifier Source: org_study_id