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

Phase 4

Completed

• Conditions: Diabetes
• Interventions: Drug: Dabigatran; Drug: Warfarin; Drug: Acenocumarole; Drug: Apixaban; Drug: Rivaroxaban; Drug: Edoxaban

• Registration Number: NCT02935855
• Lead Sponsor: University of Pavia

Brief 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

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2016-10-01
• Study First Submitted QC: 2016-10-17
• Study First Posted: 2016-10-18
• Primary Completion: 2019-04
• Study Completion: 2019-09
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-08
• Last Update Posted: 2020-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

• patients with cancer
• patients with chronic inflammation diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diabetics (group 1)	Dabigatran	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
Diabetics (group 1)	Rivaroxaban	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)	Acenocumarole	Nondiabetic patients with first diagnosis of non-valvular atrial fibrillation; they will be treated with warfarin or acenocumarole as guidelines suggest
Nondiabetics (group 1)	Dabigatran	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 2)	Acenocumarole	Diabetic patients with first diagnosis of non-valvular atrial fibrillation; they will be treated with warfarin or acenocumarole as guidelines suggest
Diabetics (group 1)	Apixaban	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
Diabetics (group 2)	Warfarin	Diabetic patients with first diagnosis of non-valvular atrial fibrillation; they will be treated with warfarin or acenocumarole as guidelines suggest
Nondiabetics (group 1)	Rivaroxaban	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
Nondiabetics (group 1)	Apixaban	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
Nondiabetics (group 1)	Edoxaban	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
Nondiabetics (group 2)	Warfarin	Nondiabetic patients with first diagnosis of non-valvular atrial fibrillation; they will be treated with warfarin or acenocumarole as guidelines suggest
Diabetics (group 1)	Edoxaban	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

Primary Outcome Measures

Name	Time	Method
Efficacy on coagulation parameters	12 months	D-dimer, anti-thrombin III

Secondary Outcome Measures

Name	Time	Method
Endothelial damage	12 months	Metalloproteinases 2 and 9
Bleeding risk	12 months	HAS-BLED score
Inflammation parameters	12 months	White cells count
Oxidative status	12 months	Small and dense LDL; oxidized LDL
Heart damage	12 months	I troponin
Safety and tolerability parameters	12 months	Plasma iron

Trial Locations

Locations (1)

IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy