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

November 8, 2020 updated by: Giuseppe Derosa, University of Pavia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pavia, Italy, 27100
        • IRCCS Policlinico San Matteo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy on coagulation parameters
Time Frame: 12 months
Red cells count
12 months
Efficacy on coagulation parameters
Time Frame: 12 months
Platelets count
12 months
Efficacy on coagulation parameters
Time Frame: 12 months
fibrinogen
12 months
Efficacy on coagulation parameters
Time Frame: 12 months
D-dimer, anti-thrombin III
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding risk
Time Frame: 12 months
HAS-BLED score
12 months
Inflammation parameters
Time Frame: 12 months
Hs-CRP
12 months
Inflammation parameters
Time Frame: 12 months
White cells count
12 months
Endothelial damage
Time Frame: 12 months
Metalloproteinases 2 and 9
12 months
Oxidative status
Time Frame: 12 months
Small and dense LDL; oxidized LDL
12 months
Heart damage
Time Frame: 12 months
I troponin
12 months
Safety and tolerability parameters
Time Frame: 12 months
Serum creatinin
12 months
Safety and tolerability parameters
Time Frame: 12 months
Serum transaminases
12 months
Safety and tolerability parameters
Time Frame: 12 months
Plasma iron
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pavia

Investigators

  • Principal Investigator: Giuseppe Derosa, MD, PhD, FESC, University of Pavia and IRCCS Policlinico San Matteo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

October 1, 2016

First Submitted That Met QC Criteria

October 17, 2016

First Posted (Estimate)

October 18, 2016

Study Record Updates

Last Update Posted (Actual)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 8, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20150003862

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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