| Trial ID: | L1189 |
| Source ID: | NCT03789695
|
| Associated Drug: |
Dabigatran Etexilate
|
| Title: |
RE-ELECT. Dabigatran vs Warfarin in AF Patients With T2DM and CKD
|
| Acronym: |
RE-ELECT
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Atrial Fibrillation|T2DM (Type 2 Diabetes Mellitus)|Chronic Kidney Diseases
|
| Interventions: |
DRUG: Dabigatran Etexilate
|
| Outcome Measures: |
Primary: 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 |
|
| Sponsor/Collaborators: |
Sponsor: Irina Ermolaeva
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
200
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
|
| Start Date: |
2018-11-14
|
| Completion Date: |
2022-05
|
| Results First Posted: |
|
| Last Update Posted: |
2021-03-26
|
| Locations: |
I.M.Sechenov First Moscow State Medical University (Sechenov University), Moscow, 119991, Russian Federation
|
| URL: |
https://clinicaltrials.gov/show/NCT03789695
|
