Atrial fibrillation MedDRA version: 20.0 Level: LLT Classification code 10001452 Term: AFib System Organ Class: 100000004849
Conditions
Interventions
Trade Name: ELIQUIS - 5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PVC/PVDC/ALU) - 20 COMPRESSE
Product Name: Eliquis
Product Code: [041225069]
Pharmaceutical Form: Film-coated tablet
I
Sponsors
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Men and post-menopause women of age 45 to 80 years with AF who need anticoagulation treatment.No contraindications to Apixaban and Warfarin as per registration. Presence of ischemic heart disease or diabetes (type II). Ability to understand and sign the informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
Exclusion criteria: Any acute or chronic condition (infections, cancer, chronic inflammatory diseases) that may interfere with microRNA assessment. Because of the policy of our Ethic Committee on Women of childbearing potential,no women of child bearing potential will be enrolled. • Malignant hypertension - • Patients without supervision and/or at high risk of low compliance to treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective of this prospective randomized study is to assess whether Apixaban significantly modifies microRNA involved in:1- coagulation 2- left ventricle and atrium function, 3- atrial fibrillation as compared to standard therapy with Warfarin. A population of 50 patients with ischemic heart disease and/or type 2 diabetes (T2DM) will be randomized to Apixaban or Warfarin to evaluate differences in the expression of specific circulating microRNAs before and after treatment. The primary end-point is to test whether the differences of the top three differentially expressed microRNA involved in coagulation between patients randomized to Apixaban and Warfarin at 3-month follow-up are statistically significant (p < 0.05).;Secondary Objective: Secondary Objective: Assess whether Apixaban positively modify microRNA involved in platelet function as compared to Warfarin;Primary end point(s): differences of the top three differentially expressed microRNA involved in coagulation between patients randomized to Apixaban and Warfarin ;Timepoint(s) of evaluation of this end point: 3-month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Lack of thrombo-embolic events;Timepoint(s) of evaluation of this end point: 3 mounth | — |
Countries
Italy
Contacts
Public ContactAREA CARDIOVASCOLARE
FONDAZIONE POLICLINICO GEMELLI
Outcome results
None listed