Completed

REGATAGastroprotective Effects of Rebamipide, Pantoprazole, and Their Combination in AF Patients on DOACs

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What is being tested

Rebamipide 100mg

+ Pantoprazole

Drug
Who is being recruted

Arrhythmias, Cardiac+3

+ Atrial Fibrillation

+ Cardiovascular Diseases

From 18 to 80 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: January 2022
See protocol details

Summary

Principal SponsorPirogov Russian National Research Medical University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 11, 2022

Actual date on which the first participant was enrolled.

This study focuses on patients with atrial fibrillation, a heart condition that causes an irregular heartbeat, and who also have a moderate to high risk of developing blood clots. These patients are either currently taking direct oral anticoagulants (DOACs), medications that prevent blood clots, or they need to start taking them. The study also includes patients who need gastroprotection, which helps protect the stomach from issues like ulcers and inflammation. The main goal is to test the effectiveness of a drug called Rebamipide in protecting the stomach, compared to another drug called Pantoprazole and a combination of both. This research is important as it aims to find the best way to protect the stomach while also preventing blood clots in patients with atrial fibrillation. During the study, patients will be randomly assigned to one of three groups. One group will receive standard therapy along with Rebamipide, another group will receive standard therapy and Pantoprazole, and the last group will receive standard therapy, Rebamipide, and Pantoprazole. The study will last up to 24 weeks and include four visits. At each visit, the patients will have a physical examination, their blood pressure and heart rate will be measured, and any side effects will be checked. Additionally, the patients will answer questions about their symptoms and have blood and stool tests. The study will look at whether patients experience any stomach-related issues, such as bleeding, ulcers, or severe discomfort, to determine the effectiveness of each treatment.

Official TitleOpen 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)
Principal SponsorPirogov Russian National Research Medical University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

210 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arrhythmias, CardiacAtrial FibrillationCardiovascular DiseasesHeart DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Criteria

3 inclusion criteria required to participate
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, Чronic erosive gastritis, Need for

8 exclusion criteria prevent from participating
Participation in the study is unsafe according to the investigator opinion

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
100 mg 3 times per day

Group II

Experimental
Rebamipide 100 mg plus pantoprazol 40 mg

Group III

Active Comparator
pantoprazol 40 mg Daily

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Russian Research and Clinical Center for Gerontology

Moscow, RussiaOpen Russian Research and Clinical Center for Gerontology in Google Maps
CompletedOne Study Center