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

Condition(s) targeted: Positive Helicobacter Pylori Serology; Coronary Thrombosis; Supra-Aortic Artery Thrombosis

Intervention: during one week for the active treatments (Drug); Pantoprazole (Drug); Placebo Formula 515 (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Assistance Publique - Hôpitaux de Paris

Official(s) and/or principal investigator(s):
Dominique Lamarque, MD, PhD, Principal Investigator, Affiliation: Assistance Publique - Hôpitaux de Paris

Overall contact:
Dominique Lamarque, MD, PhD, Phone: +33(0)1 42 34 82 99, Email: dominique.lamarque@htd.aphp.fr

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.

Official title: 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

Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: Measure: severity of the ulcerated gastric lesions induced by the aspirin

Secondary outcome:

To measure: percentage of patients having had at least an ulcer

To measure: the average of the ranks of lesion in antrum and corpus.

To measure percentage of patients having had digestive clinical events

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

To measure Percentage of patients having a hemorrhagic digestive of clinical expression or detected by the biological tests.

To measure : Elements of the histopathologic score of Sydney

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Dominique Lamarque, MD, PhD, Phone: +33(0)1 42 34 82 99, Email: dominique.lamarque@htd.aphp.fr

Hotel Dieu Hospital, Paris 75181, France; Recruiting
Dominique Lamarque, MD, PhD, Phone: +33(0)1 42 34 82 99, Email: dominique.lamarque@htd.aphp.fr
Dominique Lamarque, MD, PhD, Principal Investigator

Starting date: April 2008
Last updated: September 29, 2009