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

Diabetes Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02935855
• Other study ID #: 20150003862
• Status: Completed
• Phase: Phase 4
• Start date: September 2015
• Est. completion date: September 2019

Study information

• Verified date: November 2020
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• patients with cancer
• patients with chronic inflammation diseases

Related Conditions & MeSH terms

• Atrial Fibrillation
• Diabetes

Intervention

Drug:
• Dabigatran

• Apixaban

• Rivaroxaban

• Edoxaban

• Warfarin

• Acenocumarole

Locations

Country	Name	City	State
Italy	IRCCS Policlinico San Matteo	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy on coagulation parameters	Red cells count	12 months
Primary	Efficacy on coagulation parameters	Platelets count	12 months
Primary	Efficacy on coagulation parameters	fibrinogen	12 months
Primary	Efficacy on coagulation parameters	D-dimer, anti-thrombin III	12 months
Secondary	Bleeding risk	HAS-BLED score	12 months
Secondary	Inflammation parameters	Hs-CRP	12 months
Secondary	Inflammation parameters	White cells count	12 months
Secondary	Endothelial damage	Metalloproteinases 2 and 9	12 months
Secondary	Oxidative status	Small and dense LDL; oxidized LDL	12 months
Secondary	Heart damage	I troponin	12 months
Secondary	Safety and tolerability parameters	Serum creatinin	12 months
Secondary	Safety and tolerability parameters	Serum transaminases	12 months
Secondary	Safety and tolerability parameters	Plasma iron	12 months