Heart Patients' stomach ulcer prevention study pulled before starting
NCT ID NCT00713947
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study was designed to see if treating a common stomach bacteria (H. pylori) along with using a stomach acid drug could prevent ulcers caused by low-dose aspirin. It planned to enroll adults with heart or artery disease who needed long-term aspirin therapy. However, the study was withdrawn before any participants were enrolled, so no results are available.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Start date
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Apr 2008
- Finished
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Mar 2010
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hotel Dieu Hospital
Paris, 75181, France
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Other studies related to the condition(s) this trial covers.
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