ADALA

Phase 1

• Conditions: ATRIAL FIBRILLATION IN PATIENTS AFTER OCCLUSION OF THE LEFT ATRIAL APPENDAGE (LAAC); Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2018-001013-32-ES
• Lead Sponsor: HOSPITAL CLÍNIC BARCELONA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-10
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Age> 18 years
• NVAF (paroxysmal, persistent or permanent)
• CHADS2 score =1 or CHA2DS2-VASc score =2
* Adequate anatomy for LAA closure and contraindication for OAC (absolute or relative).
• Able to give informed consent and to be followed-up (phone and clinical visit)
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 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 136

Exclusion Criteria

• Patients with mechanical prostheses, evidence of thrombus, complex aortic atheroma or symptomatic carotid disease
• Contraindication for TEE studies
• Platelets <40000
• Absolute contraindication to Apixaban for 3 months (severe renal failure with Cl. creat <15 ml / h or severe liver disease Child B or C) or allergy to the drug.
Contraindication to any form of anticoagulation or antiplatelet therapy.
• Patients with a history of drug or alcohol abuse, or psychosocial reasons that preclude the follow-up of the patient.
•Women of childbearing potential (WOCB)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: TO DEMONSTRATE SUPERIORITY OF A STRATEGY OF ANTICOAGULATION WITH APIXABAN 5 MG/2.5 MG BID AS COMPARED WITH THE CURRENT STANDARD OF CARE (DUAL ANTIPLATELET THERAPY) AFTER OCCLUSION OF THE LEFT ATRIAL APPENDAGE (LAAC) IN PATIENTS WITH ATRIAL FIBRILLATION;Secondary Objective: TO DEMONSTRATE SUPERIORITY OF A STRATEGY OF ANTICOAGULATION WITH APIXABAN 5 MG/2.5 MG BID AS COMPARED WITH THE CURRENT STANDARD OF CARE (DUAL ANTIPLATELET THERAPY) AFTER OCCLUSION OF THE LEFT ATRIAL APPENDAGE (LAAC) IN PATIENTS WITH ATRIAL FIBRILLATION;Primary end point(s): COMBINED OF EFFICACY (THROMBOEMBOLIC EVENTS PREVENTION AND DEVICE THROMBOIS) AND SAFETY (MAJOR BLEEDING INCIDENCE) AT 3 MONTHS WITH BOTH STRATEGIES.;Timepoint(s) of evaluation of this end point: 3 MONTHS

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 12 MONTHS;Timepoint(s) of evaluation of this end point: 12 MONTHS