Atrial FibrillationPhase 4RE-ELECTNCT03789695
RE-ELECT. Dabigatran vs Warfarin in AF Patients With T2DM and CKD
A Phase 4 study testing Dabigatran Etexilate in people with Atrial Fibrillation and T2DM (Type 2 Diabetes Mellitus), run by Irina Ermolaeva at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, T2DM (Type 2 Diabetes Mellitus), Chronic Kidney Diseases
- What is being tested?
- Dabigatran Etexilate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteRussia
- Study dates
- 14 Nov 2018to May 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
I.M.Sechenov First Moscow State Medical University (Sechenov University)
Moscow, 119991
Dmitry Napalkov, +79104520841, dminap@mail.ru
Anastasia Sokolova, +79036135898, sokolovastasya2@gmail.com
About this study
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"
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.
Read the 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
- Being tested
- Dabigatran Etexilate
- Medical subject headings
- Atrial Fibrillation, Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dabigatran EtexilateDrug
Also called Pradaxa
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
| Study group | Role | What they receive |
|---|---|---|
| Dabigatran etexilate | Experimental | Dabigatran etexilate (Pradaxa) 110 mg b.i.d. or 150 mg b.i.d. according SmPC during 2 years Receives: Drug: Dabigatran Etexilate |
| Warfarin | Active comparator | Warfarin under the control of INR once a month (target range 2.0 - 3.0) during 2 years Receives: Drug: Dabigatran Etexilate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2018
- Study start14 Nov 2018
- Primary completionJul 2021 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Irina Ermolaeva
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Irina Ermolaeva, I.M. Sechenov First Moscow State Medical University
- Investigators
- Dmitry Napalkov, Principal investigator, First Moscow State Medical University (Sechenov's University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789695
- Sponsor's protocol ID
- 1160.283
- Acronym
- RE-ELECT
- Status last verified
- Mar 2021
- First submitted
- 27 Dec 2018
- Last updated
- 26 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT03789695
- Acronym / sponsor ID
- RE-ELECT / 1160.283
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Irina ErmolaevaUniversity, hospital or other
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 31 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dabigatran etexilate | Experimental | Drug: Dabigatran EtexilateDabigatran etexilate (Pradaxa) 110 mg b.i.d. or 150 mg b.i.d. according SmPC during 2 years |
| Warfarin | Active comparator | Drug: Dabigatran EtexilateWarfarin under the control of INR once a month (target range 2.0 - 3.0) during 2 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dabigatran EtexilateAlso: PradaxaStudy 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 | Drug | Dabigatran etexilate, Warfarin |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dmitry Napalkov principal investigator
First Moscow State Medical University (Sechenov's University)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dabigatran Etexilate in people with Atrial Fibrillation and T2DM (Type 2 Diabetes Mellitus), run by Irina Ermolaeva at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dmitry Napalkov (+79104520841, dminap@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in annual eGFR decline (slopes) between dabigatran and warfarin patients (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2021.