New hope for stomach protection in heart patients on blood thinners
NCT ID NCT07354230
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether rebamipide, a stomach-protecting drug, can prevent bleeding and ulcers in people with atrial fibrillation who take blood thinners (DOACs). 210 adults were randomly assigned to receive rebamipide, pantoprazole, or both for 24 weeks. The goal was to see which approach best prevents stomach problems like bleeding or severe indigestion.
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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.
- Participants
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210 people
The number who actually took part.
- Started
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Jan 2022
- Finished
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Sep 2024
- 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 to 80 years
- 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Men and women from 18 till 80 years old * Patients with atrial fibrillation (AF) and a moderate or high risk of thromboembolic complications (\>=1 point in men and \>=2 points in women according to the CHA2DS2VASc scale), receiving DOAC (rivaroxaban, apixaban or dabigatran) for the prevention of thromboembolic complications * The following indications for the use of rebamipide and/or pantoprazole: * Chronic gastritis with high acidity in combination with gastroesophageal reflux disease * Peptic ulcer if negative test for H. pylori * Сhronic erosive gastritis * Need for Exclusion Criteria: * Refusal to participate in the study * Participation in any other clinical trial or taking study drugs within 3 months before enrollment; * Contraindications to study procedures * Participation in the study is unsafe according to the investigator opinion. * Admission of prohibited medication * Pregnancy and lactation, as well as the inability to use reliable contraception in women of childbearing age * Peptic ulcer in the acute stage * Acute erosion on screening visit
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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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Russian Research and Clinical Center for Gerontology
Moscow, 129226, Russia
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