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RE-ELECT. Dabigatran vs Warfarin in AF Patients With T2D and CKD (RE-ELECT)

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ClinicalTrials.gov Identifier: NCT03789695
Recruitment Status : Recruiting
First Posted : December 31, 2018
Last Update Posted : December 31, 2018
Sponsor:
Information provided by (Responsible Party):
Irina Ermolaeva, I.M. Sechenov First Moscow State Medical University

Brief Summary:
Kidney function in patients with atrial fibrillation (AF) is tending to decline over a time which is clearly demonstrated in clinical studies. Taking into account that renal impairment is a risk factor for stroke and its progression is associated with unfavorable prognosis it's clear that 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 or in patients who are under risk of its development. This is especially relevant for the patients with Diabetes mellitus and with Chronic kidney disease who can be considered as a group of risk of rapid progression of kidney function decline.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation T2D Chronic Kidney Diseases Drug: Dabigatran Etexilate Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: RE-ELECT Study: "Randomized Evaluation of Changing Kidney Function Over a Time in Patients With Atrial Fibrillation, Concomitant T2D and Existing Chronic Kidney Disease Treated With Dabigatran or Warfarin for Stroke Prevention", № 1160.283
Actual Study Start Date : November 14, 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : May 2022


Arm Intervention/treatment
Active Comparator: Dabigatran Drug: Dabigatran Etexilate
study drug dabigatran etexilate. There are two dosage regimens of dabigatran used in the study: 150 mg BID and 110 mg BID. The dose of dabigatran will be chosen by the investigator in accordance with Russian PRADAXA SmpC

Active Comparator: Warfarin Drug: Dabigatran Etexilate
study drug dabigatran etexilate. There are two dosage regimens of dabigatran used in the study: 150 mg BID and 110 mg BID. The dose of dabigatran will be chosen by the investigator in accordance with Russian PRADAXA SmpC




Primary Outcome Measures :
  1. Difference in annual eGFR decline (slopes) between dabigatran and warfarin patients [ Time Frame: 2 years ]
    • 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789695


Contacts
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Contact: Dmitry Napalkov +79104520841 dminap@mail.ru

Locations
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Russian Federation
I.M.Sechenov First Moscow State Medical University (Sechenov University) Recruiting
Moscow, Russian Federation, 119991
Contact: Dmitry Napalkov    +79104520841    dminap@mail.ru   
Contact: Anastasia Sokolova    +79036135898    sokolovastasya2@gmail.com   
Sponsors and Collaborators
Irina Ermolaeva

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Responsible Party: Irina Ermolaeva, Head of Department of preclinical and clinical trials management, I.M. Sechenov First Moscow State Medical University
ClinicalTrials.gov Identifier: NCT03789695     History of Changes
Other Study ID Numbers: 1160.283
First Posted: December 31, 2018    Key Record Dates
Last Update Posted: December 31, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dabigatran
Kidney Diseases
Renal Insufficiency, Chronic
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Urologic Diseases
Renal Insufficiency
Warfarin
Anticoagulants
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action