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

• Sponsor: University of Pavia (Other)
• Overall Status: Completed
• CT.gov ID: NCT02935855
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Arms: 4
• Duration (Months): 48
• Patients Per Site Per Month: 6.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes	Drug: Dabigatran; Drug: Apixaban; Drug: Rivaroxaban; Drug: Edoxaban; Drug: Warfarin; Drug: Acenocumarole	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Sep 1, 2015
• Actual Primary Completion Date: Apr 1, 2019
• Actual Study Completion Date: Sep 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Efficacy on coagulation parameters [12 months]

   Red cells count

2. Efficacy on coagulation parameters [12 months]

   Platelets count

3. Efficacy on coagulation parameters [12 months]

   fibrinogen

4. Efficacy on coagulation parameters [12 months]

   D-dimer, anti-thrombin III

Secondary Outcome Measures

1. Bleeding risk [12 months]

   HAS-BLED score

2. Inflammation parameters [12 months]

   Hs-CRP

3. Inflammation parameters [12 months]

   White cells count

4. Endothelial damage [12 months]

   Metalloproteinases 2 and 9

5. Oxidative status [12 months]

   Small and dense LDL; oxidized LDL

6. Heart damage [12 months]

   I troponin

7. Safety and tolerability parameters [12 months]

   Serum creatinin

8. Safety and tolerability parameters [12 months]

   Serum transaminases

9. Safety and tolerability parameters [12 months]

   Plasma iron

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• non-valvular atrial fibrillation

• nondiabetic patients

• type 1 and 2 diabetic patients

Exclusion Criteria:

• patients with cancer

• patients with chronic inflammation diseases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Policlinico San Matteo	Pavia		Italy	27100

Sponsors and Collaborators

• University of Pavia

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Giuseppe Derosa, Principal Investigator, University of Pavia
• ClinicalTrials.gov Identifier: NCT02935855
• Other Study ID Numbers: 20150003862
• First Posted: Oct 18, 2016
• Last Update Posted: Nov 10, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Giuseppe Derosa, Principal Investigator, University of Pavia: Diabetic patients; nondiabetic patients
• Additional relevant MeSH terms: Atrial Fibrillation; Warfarin; Rivaroxaban; Dabigatran; Apixaban; Edoxaban

Study Results

No Results Posted as of Nov 10, 2020