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

Primary Purpose

Positive Helicobacter Pylori Serology, Coronary Thrombosis, Supra-aortic Artery Thrombosis

Status
Withdrawn
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
during one week for the active treatments
Pantoprazole
Placebo Formula 515
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Positive Helicobacter Pylori Serology focused on measuring Gastric lesions induced by low dose of aspirin, Helicobacter pylori

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hotel Dieu Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Placebo Comparator

Arm Label

A

B

C

Arm Description

Amoxicillin, Clarythromycin or metronidazole,Pantoprazole,Placebo

Pantoprazole

Placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 18, 2008
Last Updated
April 20, 2015
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00713947
Brief Title
Effectiveness of the Eradication of Helicobacter Pylori and an Inhibitor of Pump With Proton Versus Control
Acronym
Aspylori
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

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Withdrawn
Why Stopped
no inclusion
Study Start Date
April 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Positive Helicobacter Pylori Serology, Coronary Thrombosis, Supra-aortic Artery Thrombosis
Keywords
Gastric lesions induced by low dose of aspirin, Helicobacter pylori

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Amoxicillin, Clarythromycin or metronidazole,Pantoprazole,Placebo
Arm Title
B
Arm Type
Experimental
Arm Description
Pantoprazole
Arm Title
C
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
during one week for the active treatments
Other Intervention Name(s)
Amoxicillin, Clarythromycin or metronidazole, Pantoprazole, Placebo
Intervention Description
during one week for the active treatments placebo during 25 weeks
Intervention Type
Drug
Intervention Name(s)
Pantoprazole
Intervention Description
6 months at 20 mg
Intervention Type
Drug
Intervention Name(s)
Placebo Formula 515
Intervention Description
26 weeks, one tablet per day
Primary Outcome Measure Information:
Title
Measure: severity of the ulcerated gastric lesions induced by the aspirin
Time Frame
6 months
Secondary Outcome Measure Information:
Title
To measure: percentage of patients having had at least an ulcer
Time Frame
6 months
Title
To measure: the average of the ranks of lesion in antrum and corpus.
Time Frame
6 months
Title
To measure percentage of patients having had digestive clinical events
Time Frame
6 months
Title
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
Title
To measure Percentage of patients having a hemorrhagic digestive of clinical expression or detected by the biological tests.
Time Frame
6 months
Title
To measure : Elements of the histopathologic score of Sydney
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique Lamarque, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hotel Dieu Hospital
City
Paris
ZIP/Postal Code
75181
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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