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OpenTrials
Completed

NCT Number: NCT02935855

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

IRCCS Policlinico San Matteo

Pavia, 27100, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • patients with cancer
  • patients with chronic inflammation diseases

Treatment and study plan

dabigatran

Drug

Apixaban

Drug

Rivaroxaban

Drug

Edoxaban

Drug

Warfarin

Drug

Acenocumarole

Drug

Primary outcomes

  1. Efficacy on coagulation parameters

    Time frame: 12 months

    Red cells count

  2. Efficacy on coagulation parameters

    Time frame: 12 months

    Platelets count

  3. Efficacy on coagulation parameters

    Time frame: 12 months

    fibrinogen

  4. Efficacy on coagulation parameters

    Time frame: 12 months

    D-dimer, anti-thrombin III

Secondary outcomes

  1. Bleeding risk

    Time frame: 12 months

    HAS-BLED score

  2. Inflammation parameters

    Time frame: 12 months

    Hs-CRP

  3. Inflammation parameters

    Time frame: 12 months

    White cells count

  4. Endothelial damage

    Time frame: 12 months

    Metalloproteinases 2 and 9

  5. Oxidative status

    Time frame: 12 months

    Small and dense LDL; oxidized LDL

  6. Heart damage

    Time frame: 12 months

    I troponin

  7. Safety and tolerability parameters

    Time frame: 12 months

    Serum creatinin

  8. Safety and tolerability parameters

    Time frame: 12 months

    Serum transaminases

  9. Safety and tolerability parameters

    Time frame: 12 months

    Plasma iron

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study title

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

Acronym: ORGANON

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Oct 18, 2016
Registry last updated
Nov 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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