NCT07354230

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2022

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2025

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
Last Updated

January 21, 2026

Status Verified

May 1, 2025

Enrollment Period

2.7 years

First QC Date

June 11, 2025

Last Update Submit

January 14, 2026

Conditions

Atrial Fibrillation (AF)

Keywords

RebamipidePantoprasoleAtrial fibrillationDOACsGastroprotection

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Group Rebamipide

EXPERIMENTAL

100 mg 3 times per day

Drug: Rebamipide 100mg

Group Pantoprazole

ACTIVE COMPARATOR

pantoprazol 40 mg Daily

Drug: Pantoprazole

Group combination of Rebamipide and Pantoprazole

EXPERIMENTAL

Rebamipide 100 mg plus pantoprazol 40 mg

Drug: Rebamipide 100mgDrug: Pantoprazole

Interventions

Rebamipide 100mgDRUG

Rebamipide 100 mg three times per day

Group RebamipideGroup combination of Rebamipide and Pantoprazole
PantoprazoleDRUG

40 mg once daily

Group PantoprazoleGroup combination of Rebamipide and Pantoprazole

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Russian Research and Clinical Center for Gerontology

Moscow, 129226, Russia

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

rebamipidePantoprazole

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Olga Tkacheva

    Pirogov Russian National Research Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2025

First Posted

January 21, 2026

Study Start

January 11, 2022

Primary Completion

September 20, 2024

Study Completion

September 20, 2024

Last Updated

January 21, 2026

Record last verified: 2025-05

Locations

RU(1)