Effectiveness of the Eradication of Helicobacter Pylori and an Inhibitor of Pump With Proton Versus Control - Full Text View

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00713947

Purpose

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.

Condition	Intervention	Phase
Positive Helicobacter Pylori Serology Coronary Thrombosis Supra-Aortic Artery Thrombosis	Drug: during one week for the active treatments Drug: Pantoprazole Drug: Placebo Formula 515	Phase IV

Drug Information available for: Pantoprazole Pantoprazole Sodium Amoxicillin Amoxicillin sodium Amoxicillin trihydrate Clarithromycin Metronidazole Metronidazole hydrochloride Metronidazole phosphate Acetylsalicylic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Measure: severity of the ulcerated gastric lesions induced by the aspirin [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To measure: percentage of patients having had at least an ulcer [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
To measure: the average of the ranks of lesion in antrum and corpus. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
To measure percentage of patients having had digestive clinical events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
To measure Percentage of patients having a hemorrhagic digestive of clinical expression or detected by the biological tests. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
To measure : Elements of the histopathologic score of Sydney [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	549
Study Start Date:	July 2008
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Amoxicillin, Clarythromycin or metronidazole,Pantoprazole,Placebo	Drug: during one week for the active treatments during one week for the active treatments placebo during 25 weeks
B: Experimental Pantoprazole	Drug: Pantoprazole 6 months at 20 mg
C: Placebo Comparator Placebo	Drug: Placebo Formula 515 26 weeks, one tablet per day

Detailed Description:

The aim of the study is to compare the protective effect of H. pylori eradication versus PPI 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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00713947

Contacts

Contact: Dominique Lamarque, MD, PhD	+33(0)1 42 34 82 99	dominique.lamarque@htd.aphp.fr
Contact: Raphael SERREAU, MD, PhD		raphael.serreau@cch.aphp.fr

Locations

France
Hotel Dieu Hospital
Paris, France, 75181

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Dominique Lamarque, MD, PhD

AP-HP

More Information

Responsible Party:	Department Clinical Research of Developpement ( Cécile Kedzia )
Study ID Numbers:	P051021, AOM 05114
Study First Received:	June 18, 2008
Last Updated:	July 16, 2008
ClinicalTrials.gov Identifier:	NCT00713947
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Gastric lesions induced by low dose of aspirin
Helicobacter pylori

Study placed in the following topic categories:

Metronidazole
Amoxicillin
Heart Diseases
Pantoprazole
Myocardial Ischemia
Vascular Diseases
Coronary Thrombosis
Ischemia

Thrombosis
Coronary Disease
Clarithromycin
Embolism and Thrombosis
Aspirin
Embolism
Coronary Artery Disease

Additional relevant MeSH terms:

Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009