Back to resultsRE-ELECT. Dabigatran vs Warfarin in AF Patients With T2DM and CKD (RE-ELECT)
Primary Purpose
Atrial Fibrillation, T2DM (Type 2 Diabetes Mellitus), Chronic Kidney Diseases
Status
Unknown status
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
Dabigatran Etexilate
Sponsored by
About this trial
This is an interventional other trial for Atrial Fibrillation
Eligibility Criteria
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, 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
Sites / Locations
- I.M.Sechenov First Moscow State Medical University (Sechenov University)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dabigatran etexilate
Warfarin
Arm Description
Dabigatran etexilate (Pradaxa) 110 mg b.i.d. or 150 mg b.i.d. according SmPC during 2 years
Warfarin under the control of INR once a month (target range 2.0 - 3.0) during 2 years
Outcomes
Primary Outcome Measures
Difference in annual eGFR decline (slopes) between dabigatran and warfarin patients
eGFR is to be calculated with CKD-EPI equation at baseline and at subsequent major visits.
for primary analysis only eGFR levels at one year and second year of treatment will be used. In case of one of values required for the analysis is missed LOCF (last observational carried forward) approach will be used
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03789695
Brief Title
RE-ELECT. Dabigatran vs Warfarin in AF Patients With T2DM and CKD
Acronym
RE-ELECT
Official Title
RE-ELECT Study: "Randomized Evaluation of Changing Kidney Function Over a Time in Patients With Atrial Fibrillation (AF), Concomitant T2DM and Existing Chronic Kidney Disease (CKD) Treated With Dabigatran or Warfarin for Stroke Prevention"
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 14, 2018 (Actual)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
May 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Irina Ermolaeva
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 progression is associated with unfavorable prognosis. So preserving kidney function should be considered as a one of priorities when choosing treatment strategies which is especially important in patients with existing chronic kidney disease (CKD) or in patients who have risk of its development. This is especially relevant for the patients with type 2 diabetes mellitus (T2DM) and with CKD who can be considered as a group of risk for rapid kidney function decline.
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 phase IV randomized trial in which patients with AF, T2DM and CKD will be randomized to groups receiving either dabigatran etexilate (Pradaxa) or warfarin. The main goal of the study is to assess the differences in annual eGFR reduction between patients receiving dabigatran etexilate (Pradaxa) or warfarin for 24 months. The difference in annual eGFR reduction will be estimated using the SMPI parameters (mixed model of repeated measurements). Secondary goals are as follows: - to evaluate the progression of albuminuria during treatment with dabigatran etexilate (Pradaxa) or warfarin based on the combined endpoint; - to evaluate the dynamics of the albumin/creatinine ratio (ACR) in urine during 2 years of treatment with dabigatran etexilate (Pradaxa) or warfarin; - to evaluate bleeding episodes, acute cerebrovascular accident, and systemic embolism in the dabigatran etexilate (Pradaxa) and warfarin groups; - to compare glycemic control (HbA1c) in patients receiving dabigatran etexilate (Pradaxa) and warfarin
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, T2DM (Type 2 Diabetes Mellitus), Chronic Kidney Diseases
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dabigatran etexilate
Arm Type
Experimental
Arm Description
Dabigatran etexilate (Pradaxa) 110 mg b.i.d. or 150 mg b.i.d. according SmPC during 2 years
Arm Title
Warfarin
Arm Type
Active Comparator
Arm Description
Warfarin under the control of INR once a month (target range 2.0 - 3.0) during 2 years
Intervention Type
Drug
Intervention Name(s)
Dabigatran Etexilate
Other Intervention Name(s)
Pradaxa
Intervention Description
Study drug dabigatran etexilate. There are two dosage regimens of dabigatran etexilate used in the study: 150 mg b.i.d. and 110 mg b.i.d. The dose of dabigatran etexilate will be chosen by the investigator in accordance with Russian PRADAXA SmPC
Primary Outcome Measure Information:
Title
Difference in annual eGFR decline (slopes) between dabigatran and warfarin patients
Description
eGFR is to be calculated with CKD-EPI equation at baseline and at subsequent major visits.
for primary analysis only eGFR levels at one year and second year of treatment will be used. In case of one of values required for the analysis is missed LOCF (last observational carried forward) approach will be used
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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, 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dmitry Napalkov
Phone
+79104520841
Email
dminap@mail.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dmitry Napalkov
Organizational Affiliation
First Moscow State Medical University (Sechenov's University)
Official's Role
Principal Investigator
Facility Information:
Facility Name
I.M.Sechenov First Moscow State Medical University (Sechenov University)
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dmitry Napalkov
Phone
+79104520841
Email
dminap@mail.ru
First Name & Middle Initial & Last Name & Degree
Anastasia Sokolova
Phone
+79036135898
Email
sokolovastasya2@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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RE-ELECT. Dabigatran vs Warfarin in AF Patients With T2DM and CKD
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