Gastroprotective Efficacy of Rebamipide in Patients With Atrial Fibrillation Treated With DOACs (REGATA)

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation (AF)
• Intervention / Treatment: Drug: Rebamipide 100mg; Drug: Pantoprazole

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 Type: Interventional
• Enrollment (Actual): 210
• Phase: Phase 4

Contacts and Locations

Study Locations

• Russia
  • Moscow, Russia, 129226
    • Russian Research and Clinical Center for Gerontology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group Rebamipide; 100 mg 3 times per day	Drug: Rebamipide 100mg; Rebamipide 100 mg three times per day
Active Comparator: Group Pantoprazole; pantoprazol 40 mg Daily	Drug: Pantoprazole; 40 mg once daily
Experimental: Group combination of Rebamipide and Pantoprazole; Rebamipide 100 mg plus pantoprazol 40 mg	Drug: Rebamipide 100mg; Rebamipide 100 mg three times per day; Drug: Pantoprazole; 40 mg once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	up to 24 weeks

Collaborators and Investigators

• Sponsor: Pirogov Russian National Research Medical University
• Investigators: Principal Investigator: Olga Tkacheva, Pirogov Russian National Research Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2022
• Primary Completion (Actual): September 20, 2024
• Study Completion (Actual): September 20, 2024

Study Registration Dates

• First Submitted: June 11, 2025
• First Submitted That Met QC Criteria: January 14, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Gastroprotection; Rebamipide; DOACs; Pantoprasole
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pantoprazole; rebamipide
• Other Study ID Numbers: NIR-2021/12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No