Status:
WITHDRAWN
Effectiveness of the Eradication of Helicobacter Pylori and an Inhibitor of Pump With Proton Versus Control
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Positive Helicobacter Pylori Serology
Coronary Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
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 r...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00713947
Start Date
April 1 2008
End Date
March 1 2010
Last Update
April 21 2015
Active Locations (1)
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1
Hotel Dieu Hospital
Paris, France, 75181