Loading clinical trials...
Loading clinical trials...
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.
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.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
Russian Research and Clinical Center for Gerontology
Moscow, Russia
Start Date
January 11, 2022
Primary Completion Date
September 20, 2024
Completion Date
September 20, 2024
Last Updated
January 21, 2026
210
ACTUAL participants
Rebamipide 100mg
DRUG
Pantoprazole
DRUG
Lead Sponsor
Pirogov Russian National Research Medical University
NCT06935591
NCT07430007
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07272902