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

• Register: ClinicalTrials.gov
• Last refreshed on: 4 May 2015
• Main ID: NCT00713947
• Date of registration: 18/06/2008
• Prospective Registration: No
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Effectiveness of the Eradication of Helicobacter Pylori and an Inhibitor of Pump With Proton Versus Control Aspylori
• Scientific 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
• Date of first enrolment: April 2008
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT00713947
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

France

Contacts

• Name: Dominique Lamarque, MD, PhD
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Coronary Thrombosis

Supra-aortic Artery Thrombosis

Positive Helicobacter Pylori Serology

Intervention(s)

Drug: during one week for the active treatments

Drug: Pantoprazole

Drug: Placebo Formula 515

Primary Outcome(s)

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

Secondary Outcome(s)

To measure: percentage of patients having had at least an ulcer [Time Frame: 6 months]

To measure: the average of the ranks of lesion in antrum and corpus. [Time Frame: 6 months]

To measure Percentage of patients having a hemorrhagic digestive of clinical expression or detected by the biological tests. [Time Frame: 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 [Time Frame: 6 months]

To measure : Elements of the histopathologic score of Sydney [Time Frame: 6 months]

To measure percentage of patients having had digestive clinical events [Time Frame: 6 months]

Secondary ID(s)

AOM 05114

P051021

Source(s) of Monetary Support

Please refer to primary and secondary sponsors