d

Phase 1

• Conditions: Atrial fibrillation; MedDRA version: 20.0Level: LLTClassification code 10001452Term: AFibSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-002755-94-IT
• Lead Sponsor: FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-05
• Last Update Posted: 5 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified