CompletedPhase 4

Gastroprotective Efficacy of Rebamipide in Patients With Atrial Fibrillation Treated With DOACs

Russia210 participantsStarted 2022-01-11

Plain-language summary

The goal of this clinical trial is to learn if Rebamipide effective in gastroprotection in patients with atrial fibrillation who are treated with Direct Oral Anticoagulants (DOACs). Another point is to compare efficacy of Rebamipide and of its combination with Pantoprazole with efficacy of Pantoprazole only. Participants will: Take one of three variants of treatments for up to 24 weeks. Visits to the clinic wil take place for screening and then every 8 weeks.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Composite endpoint

Timeframe: up to 24 weeks

Trial details

NCT IDNCT07354230

SponsorPirogov Russian National Research Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-20

View on ClinicalTrials.gov More Atrial Fibrillation (AF) trials