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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02935855

Acronym

ORGANON

Enrollment

300

Registered

2016-10-18

Start date

2015-09-30

Completion date

2019-09-30

Last updated

2020-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

Diabetic patients, nondiabetic patients

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

Interventions

DRUGDabigatran

DRUGApixaban

DRUGRivaroxaban

DRUGEdoxaban

DRUGWarfarin

DRUGAcenocumarole

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Efficacy on coagulation parameters	12 months	Red cells count

Secondary

Measure	Time frame	Description
Inflammation parameters	12 months	Hs-CRP
Endothelial damage	12 months	Metalloproteinases 2 and 9
Bleeding risk	12 months	HAS-BLED score
Heart damage	12 months	I troponin
Safety and tolerability parameters	12 months	Serum creatinin
Oxidative status	12 months	Small and dense LDL; oxidized LDL

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026