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

University of Pavia

Status and phase: Completed; Phase 4

Conditions: Diabetes

Treatments: Drug: Acenocumarole; Drug: Edoxaban; Drug: Dabigatran; Drug: Apixaban; Drug: Warfarin; Drug: Rivaroxaban

Study type: Interventional

Funder types: Other

Identifiers

NCT02935855

20150003862

Details and patient eligibility

About

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.

Full description

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

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• non-valvular atrial fibrillation
• nondiabetic patients
• type 1 and 2 diabetic patients

Exclusion criteria

• patients with cancer
• patients with chronic inflammation diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 4 patient groups

Nondiabetics (group 1)

Active Comparator group

Description:

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

Treatment:

Drug: Dabigatran

Drug: Apixaban

Drug: Edoxaban

Drug: Rivaroxaban

Diabetics (group 1)

Active Comparator group

Description:

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

Treatment:

Drug: Dabigatran

Drug: Apixaban

Drug: Edoxaban

Drug: Rivaroxaban

Nondiabetics (group 2)

Active Comparator group

Description:

Nondiabetic patients with first diagnosis of non-valvular atrial fibrillation; they will be treated with warfarin or acenocumarole as guidelines suggest

Treatment:

Drug: Warfarin

Drug: Acenocumarole

Diabetics (group 2)

Active Comparator group

Description:

Diabetic patients with first diagnosis of non-valvular atrial fibrillation; they will be treated with warfarin or acenocumarole as guidelines suggest

Treatment:

Drug: Warfarin

Drug: Acenocumarole