NCT02935855

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_4 diabetes

Timeline
Completed

Started Sep 2015

Longer than P75 for phase_4 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 1, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

3.6 years

First QC Date

October 1, 2016

Last Update Submit

November 8, 2020

Conditions

Diabetes

Keywords

Diabetic patientsnondiabetic patients

Outcome Measures

Primary Outcomes (4)

  • Efficacy on coagulation parameters

    Red cells count

    12 months

  • Efficacy on coagulation parameters

    Platelets count

    12 months

  • Efficacy on coagulation parameters

    fibrinogen

    12 months

  • Efficacy on coagulation parameters

    D-dimer, anti-thrombin III

    12 months

Secondary Outcomes (9)

  • Bleeding risk

    12 months

  • Inflammation parameters

    12 months

  • Inflammation parameters

    12 months

  • Endothelial damage

    12 months

  • Oxidative status

    12 months

  • +4 more secondary outcomes

Study Arms (4)

Nondiabetics (group 1)

ACTIVE COMPARATOR

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: DabigatranDrug: ApixabanDrug: RivaroxabanDrug: Edoxaban

Diabetics (group 1)

ACTIVE COMPARATOR

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: DabigatranDrug: ApixabanDrug: RivaroxabanDrug: Edoxaban

Nondiabetics (group 2)

ACTIVE COMPARATOR

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

Drug: WarfarinDrug: Acenocumarole

Diabetics (group 2)

ACTIVE COMPARATOR

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

Drug: WarfarinDrug: Acenocumarole

Interventions

DabigatranDRUG
Diabetics (group 1)Nondiabetics (group 1)
ApixabanDRUG
Diabetics (group 1)Nondiabetics (group 1)
RivaroxabanDRUG
Diabetics (group 1)Nondiabetics (group 1)
EdoxabanDRUG
Diabetics (group 1)Nondiabetics (group 1)
WarfarinDRUG
Diabetics (group 2)Nondiabetics (group 2)
AcenocumaroleDRUG
Diabetics (group 2)Nondiabetics (group 2)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • patients with cancer
  • patients with chronic inflammation diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Related Publications (1)

  • Derosa G, Rizzo M, Brunetti ND, Raddino R, Gavazzoni M, Pasini G, Gaudio G, Maggi A, D'Angelo A, De Gennaro L, Maffioli P. ORal anticoaGulants in diAbetic and Nondiabetic patients with nOn-valvular atrial fibrillatioN (ORGANON). J Diabetes Complications. 2023 Aug;37(8):108512. doi: 10.1016/j.jdiacomp.2023.108512. Epub 2023 May 20.

    PMID: 37390799DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

DabigatranapixabanRivaroxabanedoxabanWarfarin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazines4-HydroxycoumarinsCoumarinsBenzopyransPyrans

Study Officials

  • Giuseppe Derosa, MD, PhD, FESC

    University of Pavia and IRCCS Policlinico San Matteo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 1, 2016

First Posted

October 18, 2016

Study Start

September 1, 2015

Primary Completion

April 1, 2019

Study Completion

September 1, 2019

Last Updated

November 10, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)