Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Diabetic and nondiabetic patients will be evaluated if they had a first diagnosis of non-valvular atrial fibrillation and in therapy with non-vitamin K oral anticoagulants and with vitamin K oral anticoagulants.
Parameters evaluated:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nondiabetics (group 1) | Active Comparator | Nondiabetic patients with first diagnosis of non-valvular atrial fibrillation; they will be treated with dabigatran or apixaban or rivaroxaban or edoxaban in randomized way |
|
| Diabetics (group 1) | Active Comparator | Diabetic patients with first diagnosis of non-valvular atrial fibrillation; they will be treated with dabigatran or apixaban or rivaroxaban or edoxaban in randomized way |
|
| Nondiabetics (group 2) | Active Comparator | Nondiabetic patients with first diagnosis of non-valvular atrial fibrillation; they will be treated with warfarin or acenocumarole as guidelines suggest |
|
| Diabetics (group 2) | Active Comparator | Diabetic patients with first diagnosis of non-valvular atrial fibrillation; they will be treated with warfarin or acenocumarole as guidelines suggest |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dabigatran | Drug |
| ||
| Apixaban |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy on coagulation parameters | Red cells count | 12 months |
| Efficacy on coagulation parameters | Platelets count | 12 months |
| Efficacy on coagulation parameters | fibrinogen | 12 months |
| Efficacy on coagulation parameters | D-dimer, anti-thrombin III | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding risk | HAS-BLED score | 12 months |
| Inflammation parameters | Hs-CRP | 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Derosa, MD, PhD, FESC | University of Pavia and IRCCS Policlinico San Matteo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Policlinico San Matteo | Pavia | 27100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37390799 | Derived | Derosa G, Rizzo M, Brunetti ND, Raddino R, Gavazzoni M, Pasini G, Gaudio G, Maggi A, D'Angelo A, De Gennaro L, Maffioli P. ORal anticoaGulants in diAbetic and Nondiabetic patients with nOn-valvular atrial fibrillatioN (ORGANON). J Diabetes Complications. 2023 Aug;37(8):108512. doi: 10.1016/j.jdiacomp.2023.108512. Epub 2023 May 20. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| C522181 | apixaban |
| D000069552 | Rivaroxaban |
| C552171 | edoxaban |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| Rivaroxaban | Drug |
|
| Edoxaban | Drug |
|
| Warfarin | Drug |
|
| Acenocumarole | Drug |
|
| Inflammation parameters | White cells count | 12 months |
| Endothelial damage | Metalloproteinases 2 and 9 | 12 months |
| Oxidative status | Small and dense LDL; oxidized LDL | 12 months |
| Heart damage | I troponin | 12 months |
| Safety and tolerability parameters | Serum creatinin | 12 months |
| Safety and tolerability parameters | Serum transaminases | 12 months |
| Safety and tolerability parameters | Plasma iron | 12 months |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |