NCT02935855

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: University of Pavia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Diabetes

Interventions

Type	Name	Description
DRUG	Dabigatran
DRUG	Apixaban
DRUG	Rivaroxaban
DRUG	Edoxaban
DRUG	Warfarin
DRUG	Acenocumarole

Timeline

• Start date: 2015-09-01
• Primary completion: 2019-04-01
• Completion: 2019-09-01
• First posted: 2016-10-18
• Last updated: 2020-11-10

Locations

1 site across 1 country: Italy