Atrial Fibrillation (AF)Phase 4REGATANCT07354230
Gastroprotective Efficacy of Rebamipide in Patients With Atrial Fibrillation Treated With DOACs
A Phase 4 study testing Rebamipide 100mg and Pantoprazole in people with Atrial Fibrillation (AF), run by Pirogov Russian National Research Medical University at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Rebamipide 100mg and Pantoprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteRussia
- Study dates
- 11 Jan 2022to 20 Sep 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site
Russian Research and Clinical Center for Gerontology
Moscow, 129226
About this study
Official title: 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)
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.
Read the detailed description
The study enrolls 210 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), who receives direct oral anticoagulants (DOACs) or has indication to their dministration for prevention of thromboembolic complications and in the same time has indication for gastroprotection.
The study includes a screening period (to confirm selection criteria) and a treatment period (maximum 24 weeks), that consists of 4 visits:
- Visit 1 (randomization),
- Visit 2 and 3 - follow up,
- Visit 4 - end of study. Patients will be randomized to one of three treatment groups in a 1:1:1 ratio.
- Group Rebamipide, receiving standard therapy and rebamipide 300 mg per day
- Group Pantoprazole , receiving standard therapy and pantoprazole 40 mg per day
- Group Combination of Rebamipide and Pantoprazole, receiving standard therapy, rebamipide 300 mg per day and pantoprazole 40 mg per day Standard therapy in the study refers to the use of DOAC in accordance with applicable clinical guidelines.
Physical examination, blood pressure/heart rate measurement, Adverse Events (AEs) control, concomitant medications and compliance assessment will be performed every visit. An Esophagogastroduodenoscopy (EGD) with H. pylori detection, Lanza score assessment, GOS questionnaire, and laboratory tests (blood and stool tests) will be performed on screening and visit 4.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Rebamipide 100mg, Pantoprazole
- Keywords
- Rebamipide, Pantoprasole, Atrial fibrillation, DOACs, Gastroprotection
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rebamipide 100mgDrug
Rebamipide 100 mg three times per day
PantoprazoleDrug
40 mg once daily
| Study group | Role | What they receive |
|---|---|---|
| Group Rebamipide | Experimental | 100 mg 3 times per day Receives: Drug: Rebamipide 100mg |
| Group Pantoprazole | Active comparator | pantoprazol 40 mg Daily Receives: Drug: Pantoprazole |
| Group combination of Rebamipide and Pantoprazole | Experimental | Rebamipide 100 mg plus pantoprazol 40 mg Receives: Drug: Rebamipide 100mg; Drug: Pantoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint
Composite endpoint including the occurrence of any of the following events:
- gastrointestinal bleeding;
- symptomatic gastric or duodenal ulcer or at least 5 gastroduodenal erosions;
- obstruction of the upper gastrointestinal tract;
- perforation of the upper gastrointestinal tract;
- severe dyspepsia (6-7 points according to the GOS questionnaire)
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start11 Jan 2022
- Primary completion20 Sep 2024
- Study completion20 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pirogov Russian National Research Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olga Tkacheva, Principal investigator, Pirogov Russian National Research Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354230
- Sponsor's protocol ID
- NIR-2021/12
- Acronym
- REGATA
- Status last verified
- May 2025
- First submitted
- 11 Jun 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07354230
- Acronym / sponsor ID
- REGATA / NIR-2021/12
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- Rebamipide, Pantoprasole, Atrial fibrillation, DOACs, Gastroprotection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Pirogov Russian National Research Medical UniversityUniversity, hospital or other
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study enrolls 210 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), who receives direct oral anticoagulants (DOACs) or has indication to their dministration for prevention of thromboembolic complications and in the same time has indication for gastroprotection.
The study includes a screening period (to confirm selection criteria) and a treatment period (maximum 24 weeks), that consists of 4 visits:
- Visit 1 (randomization),
- Visit 2 and 3 - follow up,
- Visit 4 - end of study. Patients will be randomized to one of three treatment groups in a 1:1:1 ratio.
- Group Rebamipide, receiving standard therapy and rebamipide 300 mg per day
- Group Pantoprazole , receiving standard therapy and pantoprazole 40 mg per day
- Group Combination of Rebamipide and Pantoprazole, receiving standard therapy, rebamipide 300 mg per day and pantoprazole 40 mg per day Standard therapy in the study refers to the use of DOAC in accordance with applicable clinical guidelines.
Physical examination, blood pressure/heart rate measurement, Adverse Events (AEs) control, concomitant medications and compliance assessment will be performed every visit. An Esophagogastroduodenoscopy (EGD) with H. pylori detection, Lanza score assessment, GOS questionnaire, and laboratory tests (blood and stool tests) will be performed on screening and visit 4.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group Rebamipide | Experimental | Drug: Rebamipide 100mg100 mg 3 times per day |
| Group Pantoprazole | Active comparator | Drug: Pantoprazolepantoprazol 40 mg Daily |
| Group combination of Rebamipide and Pantoprazole | Experimental | Drug: Rebamipide 100mg, Drug: PantoprazoleRebamipide 100 mg plus pantoprazol 40 mg |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rebamipide 100mgRebamipide 100 mg three times per day | Drug | Group Rebamipide, Group combination of Rebamipide and Pantoprazole |
| Pantoprazole40 mg once daily | Drug | Group Pantoprazole, Group combination of Rebamipide and Pantoprazole |
Primary outcome
Composite endpoint
Time frame: up to 24 weeks
Composite endpoint including the occurrence of any of the following events: * gastrointestinal bleeding; * symptomatic gastric or duodenal ulcer or at least 5 gastroduodenal erosions; * obstruction of the upper gastrointestinal tract; * perforation of the upper gastrointestinal tract; * severe dyspepsia (6-7 points according to the GOS questionnaire)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olga Tkacheva principal investigator
Pirogov Russian National Research Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rebamipide 100mg and Pantoprazole in people with Atrial Fibrillation (AF), run by Pirogov Russian National Research Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.