ORal anticoaGulants in diAbetic and Nondiabetic Patients With nOn-valvular Atrial fibrillatioN (ORGANON)

Study Overview
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Brief Summary
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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.

Detailed Description
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Parameters evaluated: anthropometric indices glycated haemoglobin, basal and postprandial glycemia lipid profile small and dense LDL; oxidized LDL I troponin red and white cells count; platelets count creatinin, transaminases, iron fibrinogen, D-dimer, anti-thrombin III Hs-CRP, metalloproteinases 2 and 9 incidence of bleeding

Official Title
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Efficacy and Safety of Non-vitamin K Oral Anticoagulants and Vitamin K Oral Anticoagulants on Some Metabolic and Coagulation Parameters in Diabetic and Nondiabetic Patients With First Diagnosis of Non-valvular Atrial Fibrillation

Conditions
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Diabetes

Intervention / Treatment
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* Drug: Dabigatran
* Drug: Apixaban
* Drug: Rivaroxaban
* Drug: Edoxaban
* Drug: Warfarin
* Drug: Acenocumarole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: non-valvular atrial fibrillation nondiabetic patients type 1 and 2 diabetic patients Exclusion Criteria: patients with cancer patients with chronic inflammation diseases

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nondiabetics (group 1)<br>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 | Drug: Dabigatran<br> <br> Drug: Apixaban<br> <br> Drug: Rivaroxaban<br> <br> Drug: Edoxaban<br> <br> |
| Active Comparator: Diabetics (group 1)<br>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 | Drug: Dabigatran<br> <br> Drug: Apixaban<br> <br> Drug: Rivaroxaban<br> <br> Drug: Edoxaban<br> <br> |
| Active Comparator: Nondiabetics (group 2)<br>Nondiabetic patients with first diagnosis of non-valvular atrial fibrillation; they will be treated with warfarin or acenocumarole as guidelines suggest | Drug: Warfarin<br> <br> Drug: Acenocumarole<br> <br> |
| Active Comparator: Diabetics (group 2)<br>Diabetic patients with first diagnosis of non-valvular atrial fibrillation; they will be treated with warfarin or acenocumarole as guidelines suggest | Drug: Warfarin<br> <br> Drug: Acenocumarole<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding risk | HAS-BLED score | 12 months | 
| Inflammation parameters | Hs-CRP | 12 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic patients, nondiabetic patients