MedDataX Logo

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

NCT ID: NCT02935855

Last Updated: 2020-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2019-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Diabetic patients nondiabetic patients

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

Dabigatran

Intervention Type DRUG

Apixaban

Intervention Type DRUG

Rivaroxaban

Intervention Type DRUG

Edoxaban

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Dabigatran

Intervention Type DRUG

Apixaban

Intervention Type DRUG

Rivaroxaban

Intervention Type DRUG

Edoxaban

Intervention Type DRUG

Nondiabetics (group 2)

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

Group Type ACTIVE_COMPARATOR

Warfarin

Intervention Type DRUG

Acenocumarole

Intervention Type DRUG

Diabetics (group 2)

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

Group Type ACTIVE_COMPARATOR

Warfarin

Intervention Type DRUG

Acenocumarole

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dabigatran

Intervention Type DRUG

Apixaban

Intervention Type DRUG

Rivaroxaban

Intervention Type DRUG

Edoxaban

Intervention Type DRUG

Warfarin

Intervention Type DRUG

Acenocumarole

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* patients with cancer
* patients with chronic inflammation diseases
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Pavia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Giuseppe Derosa

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Giuseppe Derosa, MD, PhD, FESC

Role: PRINCIPAL_INVESTIGATOR

University of Pavia and IRCCS Policlinico San Matteo

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

IRCCS Policlinico San Matteo

Pavia, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 37390799 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20150003862

Identifier Type: -

Identifier Source: org_study_id