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

NCT03789695 | Unknown Phase 4

• 1 other identifier: 1160.283
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; T2DM (Type 2 Diabetes Mellitus); Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• 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

  2 years

Study Arms (2)

Dabigatran etexilate

EXPERIMENTAL

Dabigatran etexilate (Pradaxa) 110 mg b.i.d. or 150 mg b.i.d. according SmPC during 2 years

Drug: Dabigatran Etexilate

Warfarin

ACTIVE COMPARATOR

Warfarin under the control of INR once a month (target range 2.0 - 3.0) during 2 years

Drug: Dabigatran Etexilate

Interventions

Dabigatran Etexilate DRUG

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

Also known as: Pradaxa

Dabigatran etexilate; Warfarin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Irina Ermolaeva: lead

Study Sites (1)

I.M.Sechenov First Moscow State Medical University (Sechenov University)

Moscow, 119991, Russia

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic

Interventions

Dabigatran

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Dmitry Napalkov

  First Moscow State Medical University (Sechenov's University)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dmitry Napalkov

CONTACT

+79104520841; dminap@mail.ru

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Department of preclinical and clinical trials management

Study Record Dates

• First Submitted: December 27, 2018
• First Posted: December 31, 2018
• Study Start: November 14, 2018
• Primary Completion: July 1, 2021
• Study Completion: May 1, 2022
• Last Updated: March 26, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)