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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02935855
Recruitment Status : Unknown
Verified October 2016 by Giuseppe Derosa, University of Pavia.
Recruitment status was:  Recruiting
First Posted : October 18, 2016
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
Giuseppe Derosa, 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.

Condition or disease Intervention/treatment Phase
Diabetes Drug: Dabigatran Drug: Apixaban Drug: Rivaroxaban Drug: Edoxaban Drug: Warfarin Drug: Acenocumarole Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : September 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • patients with cancer
  • patients with chronic inflammation diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02935855


Contacts
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Contact: Giuseppe Derosa, MD, PhD, FESC +39 0382 50 2614 giuseppe.derosa@unipv.it

Locations
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Italy
IRCCS Policlinico San Matteo Recruiting
Pavia, Italy, 27100
Contact: Giuseppe Derosa, MD, PhD, FESC    +39 0382 502614    giuseppe.derosa@unipv.it   
Contact: Pamela Maffioli, MD       pamelamaffioli@hotmail.it   
Principal Investigator: Giuseppe Derosa, MD, PhD, FESC         
Sub-Investigator: Pamela Maffioli, MD         
Sponsors and Collaborators
University of Pavia
Investigators
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Principal Investigator: Giuseppe Derosa, MD, PhD, FESC University of Pavia and IRCCS Policlinico San Matteo

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Responsible Party: Giuseppe Derosa, MD, PhD, FESC, University of Pavia
ClinicalTrials.gov Identifier: NCT02935855    
Other Study ID Numbers: 20150003862
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Giuseppe Derosa, University of Pavia:
Diabetic patients
nondiabetic patients
Additional relevant MeSH terms:
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Warfarin
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Rivaroxaban
Dabigatran
Apixaban
Edoxaban
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action