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

Primary Purpose

Diabetes

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Dabigatran
Apixaban
Rivaroxaban
Edoxaban
Warfarin
Acenocumarole
Sponsored by
University of Pavia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes focused on measuring Diabetic patients, nondiabetic patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • IRCCS Policlinico San Matteo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Nondiabetics (group 1)

Diabetics (group 1)

Nondiabetics (group 2)

Diabetics (group 2)

Arm Description

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

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

Nondiabetic patients with first diagnosis of non-valvular atrial fibrillation; they will be treated with warfarin or acenocumarole as guidelines suggest

Diabetic patients with first diagnosis of non-valvular atrial fibrillation; they will be treated with warfarin or acenocumarole as guidelines suggest

Outcomes

Primary Outcome Measures

Efficacy on coagulation parameters
Red cells count
Efficacy on coagulation parameters
Platelets count
Efficacy on coagulation parameters
fibrinogen
Efficacy on coagulation parameters
D-dimer, anti-thrombin III

Secondary Outcome Measures

Bleeding risk
HAS-BLED score
Inflammation parameters
Hs-CRP
Inflammation parameters
White cells count
Endothelial damage
Metalloproteinases 2 and 9
Oxidative status
Small and dense LDL; oxidized LDL
Heart damage
I troponin
Safety and tolerability parameters
Serum creatinin
Safety and tolerability parameters
Serum transaminases
Safety and tolerability parameters
Plasma iron

Full Information

First Posted
October 1, 2016
Last Updated
November 8, 2020
Sponsor
University of Pavia
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1. Study Identification

Unique Protocol Identification Number
NCT02935855
Brief Title
ORal anticoaGulants in diAbetic and Nondiabetic Patients With nOn-valvular Atrial fibrillatioN (ORGANON)
Acronym
ORGANON
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 Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
April 2019 (Actual)
Study Completion Date
September 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pavia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes
Keywords
Diabetic patients, nondiabetic patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nondiabetics (group 1)
Arm Type
Active Comparator
Arm Description
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
Arm Title
Diabetics (group 1)
Arm Type
Active Comparator
Arm Description
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
Arm Title
Nondiabetics (group 2)
Arm Type
Active Comparator
Arm Description
Nondiabetic patients with first diagnosis of non-valvular atrial fibrillation; they will be treated with warfarin or acenocumarole as guidelines suggest
Arm Title
Diabetics (group 2)
Arm Type
Active Comparator
Arm Description
Diabetic patients with first diagnosis of non-valvular atrial fibrillation; they will be treated with warfarin or acenocumarole as guidelines suggest
Intervention Type
Drug
Intervention Name(s)
Dabigatran
Intervention Type
Drug
Intervention Name(s)
Apixaban
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban
Intervention Type
Drug
Intervention Name(s)
Edoxaban
Intervention Type
Drug
Intervention Name(s)
Warfarin
Intervention Type
Drug
Intervention Name(s)
Acenocumarole
Primary Outcome Measure Information:
Title
Efficacy on coagulation parameters
Description
Red cells count
Time Frame
12 months
Title
Efficacy on coagulation parameters
Description
Platelets count
Time Frame
12 months
Title
Efficacy on coagulation parameters
Description
fibrinogen
Time Frame
12 months
Title
Efficacy on coagulation parameters
Description
D-dimer, anti-thrombin III
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Bleeding risk
Description
HAS-BLED score
Time Frame
12 months
Title
Inflammation parameters
Description
Hs-CRP
Time Frame
12 months
Title
Inflammation parameters
Description
White cells count
Time Frame
12 months
Title
Endothelial damage
Description
Metalloproteinases 2 and 9
Time Frame
12 months
Title
Oxidative status
Description
Small and dense LDL; oxidized LDL
Time Frame
12 months
Title
Heart damage
Description
I troponin
Time Frame
12 months
Title
Safety and tolerability parameters
Description
Serum creatinin
Time Frame
12 months
Title
Safety and tolerability parameters
Description
Serum transaminases
Time Frame
12 months
Title
Safety and tolerability parameters
Description
Plasma iron
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Derosa, MD, PhD, FESC
Organizational Affiliation
University of Pavia and IRCCS Policlinico San Matteo
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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