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

Exclusion Criteria

• •HbA1c \>10%
• •UACR \> 3000
• •Renal transplant
• •Biopsy proven kidney entities other than Diabetic Kidney Disease (if known only, no kidney biopsy is planned within the study)
• •Background immunosuppressant therapy
• •Hematologic disorders which can influence hemostasis (hemoblastosis, etc.); connective tissue 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 planned for 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 before randomization
• •Major trauma or any craniocerebral trauma within 30 days before randomization
• •Uncontrolled hypertension (systolic BP\>180 and or diastolic BP\>100 while on antihypertensive 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 drugs etc.);
• •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