NCT07354230CompletedPhase 4
Gastroprotective Efficacy of Rebamipide in Patients With Atrial Fibrillation Treated With DOACs
Open Randomised Controlled parallEl Groups Study of Gastroprotective Efficacy of Rebamipide in Patients With Atrial Fibrillation and Moderate-to-high Risk of Thromboembolic Events, Who Are Treated With Direct Oral Anticoagulants (REGATA)
Source: ClinicalTrials.gov · Last updated 21 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 210 (actual)
- First submitted
- 11 Jun 2025
- Start date
- 11 Jan 2022
- Primary completion date
- 20 Sept 2024
- Lead sponsor
- Pirogov Russian National Research Medical University
- Diseases
- Atrial fibrillation
- NCT number
- NCT07354230
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 210
- From 11 Jan 2022 to the primary completion date, 20 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in any other clinical trial or taking study drugs within 3 months before enrollment;
- Admission of prohibited medication
Other illness
- Peptic ulcer in the acute stage
Age
- Pregnancy and lactation, as well as the inability to use reliable contraception in women of childbearing age
Other
- Refusal to participate in the study
- Contraindications to study procedures
- Participation in the study is unsafe according to the investigator opinion.
- Acute erosion on screening visit
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Russian Research and Clinical Center for Gerontology Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.