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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

Tracking Information
First Submitted Date  ICMJE December 27, 2018
First Posted Date  ICMJE December 31, 2018
Last Update Posted Date December 31, 2018
Actual Study Start Date  ICMJE November 14, 2018
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 27, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RE-ELECT. Dabigatran vs Warfarin in AF Patients With T2D and CKD
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Atrial Fibrillation
  • T2D
  • Chronic Kidney Diseases
Intervention  ICMJE 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
Study Arms  ICMJE
  • Active Comparator: Dabigatran
    Intervention: Drug: Dabigatran Etexilate
  • Active Comparator: Warfarin
    Intervention: Drug: Dabigatran Etexilate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 27, 2018)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2022
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dmitry Napalkov +79104520841 dminap@mail.ru
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03789695
Other Study ID Numbers  ICMJE 1160.283
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Irina Ermolaeva, I.M. Sechenov First Moscow State Medical University
Study Sponsor  ICMJE Irina Ermolaeva
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account I.M. Sechenov First Moscow State Medical University
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP