AF In Real practice on Management of oral Anticoagulation (AFIRMA 4.0)

Study identification

• EU PAS number:
  EUPAS36330
• Study ID:
  50344
• Official title and acronym:
  AF In Real practice on Management of oral Anticoagulation (AFIRMA 4.0)
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  Options for anticoagulation have been expanding steadily over the past few decades, providing a greater number of oral anticoagulant (OAC) agents for prevention and management of thromboembolic disease. In addition to the standard treatment with vitamin K antagonists (VKA) (i.e. warfarin and acenocumarol), new oral anticoagulants (non-vitamin K antagonist oral anticoagulants, NOACs) that directly target the activity of thrombin inhibitor (dabigatran) and the factor Xa inhibitors (rivaroxaban, apixaban, and edoxaban) have recently revolutionized thromboprophylaxis for stroke and systemic embolism (SE) in patients with non-valvular atrial fibrillation (NVAF). Appropriate use of these agents requires knowledge of their individual characteristics, risks, and benefits. Thus, advantages and disadvantages of each agent must be individualized to the patient and clinical setting. NOACs are the preferred choice in those NVAF populations with increased risks of both thromboembolic and bleeding events. However, the proper use of NOACs requires a careful approach to many practical aspects. In this context, we propose to use SAVANA, an innovating data-driven system based on Natural Language Processing (NLP) and big data techniques, designed to analyse unstructured data contained in electronic medical files from NVAF patients who were prescribed OACs (apixaban, dabigatran, rivaroxaban, edoxaban, acenocumarol and warfarin). The study period will be from January 2014 through December 2018 (or most recent data available). The study will occur over three phases: an initial one describing patient characteristics and treatment pathways, the second one with a description of the minor bleeding events and comparative analysis between treatments, and a third one describing stroke/SE and major bleedings and a comparative analysis between treatments.
• Study status:
  Finalised

Research institutions and networks

Institutions

Hospital Arnau de Vilanova de Valencia (HAV)

Study timelines

Date when funding contract was signed

Planned:13/07/2020

Actual:23/07/2020

Study start date

Planned:15/09/2020

Actual:17/09/2020

Date of final study report

Planned:30/11/2023

Actual:30/11/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

PFIZER

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

B0661131/PFI-API-2019-01