Clinical trial NCT00713947: Effectiveness of the Eradication of Helicobacter Pylori and an Inhibitor of Pump With Proton Versus Control
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Positive Helicobacter Pylori Serology
Coronary Thrombosis
Supra-aortic Artery Thrombosis
Keywords: Gastric lesions induced by low dose of aspirin
Helicobacter pylori
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2008-07-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Measure: severity of the ulcerated gastric lesions induced by the aspirin
timeFrame: 6 months
Secondary outcomes:
measure: To measure: percentage of patients having had at least an ulcer
timeFrame: 6 months
measure: To measure: the average of the ranks of lesion in antrum and corpus.
timeFrame: 6 months
measure: To measure percentage of patients having had digestive clinical events
timeFrame: 6 months
measure: 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
timeFrame: 6 months
measure: To measure Percentage of patients having a hemorrhagic digestive of clinical expression or detected by the biological tests.
timeFrame: 6 months
measure: To measure : Elements of the histopathologic score of Sydney
timeFrame: 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hotel Dieu Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Dominique Lamarque, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: