ADALA

ANTITHROMBOTIC THERAPY AFTER LEFT ATRIAL APPENDAGE OCCLUSION: DOUBLE ANTIPLATELET THERAPY VS. APIXABAN - ADALA

Status

Not yet recruiting

Phases

Phase 1Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001013-32-ES

Enrollment

160

Registered

2018-08-10

Start date

2018-11-08

Completion date

Unknown

Last updated

2019-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ATRIAL FIBRILLATION IN PATIENTS AFTER OCCLUSION OF THE LEFT ATRIAL APPENDAGE (LAAC)

Interventions

Trade Name: ELIQUIS Product Name: APIXABAN Pharmaceutical Form: Tablet INN or Proposed INN: APIXABAN CAS Number: 503612-47-3 Current Sponsor code: PF-0465257/BMS-562247-01 Other descriptive name: Apix

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
Secondary end point(s): 12 MONTHS;Timepoint(s) of evaluation of this end point: 12 MONTHS	—

Countries

Spain

Contacts

Public ContactANNA CAMPOS

HOSPITAL CLÍNIC BARCELONA

acampos@clinic.cat34934518746

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026