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

Coronary Thrombosis Clinical Trial

— 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00713947
• Other study ID #: P051021
• Secondary ID: AOM 05114
• Status: Withdrawn
• Phase: Phase 4
• First received: June 18, 2008
• Last updated: April 20, 2015
• Start date: April 2008
• Est. completion date: March 2010

Study information

• Verified date: April 2015
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2010
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• during one week for the active treatments
during one week for the active treatments placebo during 25 weeks
• Pantoprazole
6 months at 20 mg
• Placebo Formula 515
26 weeks, one tablet per day

Locations

Country	Name	City	State
France	Hotel Dieu Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure: severity of the ulcerated gastric lesions induced by the aspirin		6 months	Yes
Secondary	To measure: percentage of patients having had at least an ulcer		6 months	Yes
Secondary	To measure: the average of the ranks of lesion in antrum and corpus.		6 months	Yes
Secondary	To measure percentage of patients having had digestive clinical events		6 months	Yes
Secondary	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		6 months	Yes
Secondary	To measure Percentage of patients having a hemorrhagic digestive of clinical expression or detected by the biological tests.		6 months	Yes
Secondary	To measure : Elements of the histopathologic score of Sydney		6 months	Yes