Status:
UNKNOWN
RE-ELECT. Dabigatran vs Warfarin in AF Patients With T2DM and CKD
Lead Sponsor:
Irina Ermolaeva
Conditions:
Atrial Fibrillation
T2DM (Type 2 Diabetes Mellitus)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Kidney function in patients with atrial fibrillation (AF) is tending to decline over a time which is clearly demonstrated in clinical studies. Renal impairment is a risk factor for stroke, its progres...
Detailed Description
It is suggested that the decline in renal function may occur more slowly in patients receiving dabigatran etexilate (Pradaxa) compared to patients taking warfarin. The planned trial is a prospective p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03789695
Start Date
November 14 2018
End Date
May 1 2022
Last Update
March 26 2021
Active Locations (1)
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1
I.M.Sechenov First Moscow State Medical University (Sechenov University)
Moscow, Russia, 119991