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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Rebamipide | Experimental | 100 mg 3 times per day |
|
| Group Pantoprazole | Active Comparator | pantoprazol 40 mg Daily |
|
| Group combination of Rebamipide and Pantoprazole | Experimental | Rebamipide 100 mg plus pantoprazol 40 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rebamipide 100mg | Drug | Rebamipide 100 mg three times per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite endpoint | Composite endpoint including the occurrence of any of the following events:
| up to 24 weeks |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olga Tkacheva | Pirogov Russian National Research Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Russian Research and Clinical Center for Gerontology | Moscow | 129226 | Russia |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C052785 | rebamipide |
| D000077402 | Pantoprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Pantoprazole | Drug | 40 mg once daily |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |