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

March 23, 2021 updated by: Irina Ermolaeva

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"

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Dmitry Napalkov
  • Phone Number: +79104520841
  • Email: dminap@mail.ru

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 119991
        • Recruiting
        • I.M.Sechenov First Moscow State Medical University (Sechenov University)
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Dabigatran etexilate
Dabigatran etexilate (Pradaxa) 110 mg b.i.d. or 150 mg b.i.d. according SmPC during 2 years
Drug: Dabigatran Etexilate
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
Other Names:
  • Pradaxa
ACTIVE_COMPARATOR: Warfarin
Warfarin under the control of INR once a month (target range 2.0 - 3.0) during 2 years
Drug: Dabigatran Etexilate
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
Other Names:
  • Pradaxa

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Irina Ermolaeva

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dmitry Napalkov, First Moscow State Medical University (Sechenov's University)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 14, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 27, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 31, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1160.283

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings