RE-ELECT. Dabigatran vs Warfarin in AF Patients With T2DM and CKD

Inclusion Criteria:

• Non-valvular atrial fibrillation
• Diagnosis of T2D according to Russian Clinical Guidelines
• Chronic kidney disease according to KDIGO definition*
• Stable RAS background treatment
• Age > 18 yrs;
• Informed consent to participate in the study signed by the patient.

Exclusion Criteria:

• HbA1c >10%
• UACR > 3000
• Renal transplant
• Biopsy proven kidney entities other than Diabetic Kidney Disease (if known only, nokidney biopsy is planned within the study)
• Background immunosuppressant therapy
• Hematologic disorders which can influence hemostasis (hemoblastosis, etc.); connectivetissue diseases (SLE, systemic scleroderma, dermatomyositis) and any vasculitis;
• Primary or secondary antiphospholipid syndrome;
• Known cancer diagnosis;
• Major surgical interventions within 3 months before the study enrollment and plannedfor the timelines of the study;
• Clinically relevant bleeding events within 3 months before the study enrollment;
• Acute coronary syndrome, PCI or CABG within 12 months before the study enrollment;
• Hemorrhagic stroke within 12 months before the study enrollment;
• Organ damages resulted from clinically relevant bleeding within 6 months beforerandomization
• Major trauma or any craniocerebral trauma within 30 days before randomization
• Uncontrolled hypertension (systolic BP>180 and or diastolic BP>100 while onantihypertensive treatment)
• CHF III-IV functional class (by NYHA)
• Ischemic stroke within the last 14 days before randomization
• Concomitant aspirin and/or clopidogrel use;
• Persistent use of drugs with potential nephrotoxic effects (NSAIDs, cytotoxic drugsetc.);
• Need in anticoagulation treatment for disease other than AF
• Pregnancy and lactation;
• Creatinine clearance < 30 ml/min (by Cockroft - Gault equation)
• Thrombocytopenia of <100 *109 /л
• Hepatic failure B and C by Child-Pugh score
• Psychiatrist disorders
• Background poor compliance
• Known hypersensitivity to dabigatran, warfarin or their components
• Life expectancy less than two years