Evaluating the Effectiveness of Eliquis® Additional Risk Minimization Measures in Kingdom of Saudi Arabia.

Study identification

• EU PAS number:
  EUPAS1000000270
• Study ID:
  1000000270
• Official title and acronym:
  Evaluating the Effectiveness of Eliquis® Additional Risk Minimization Measures in Kingdom of Saudi Arabia.
• DARWIN EU® study:
  No
• Study countries:
  Saudi Arabia
• Study description:
  Eliquis® (apixaban) is a reversible and highly potent inhibitor of factor Xa with rapid absorption, a 12-hour half-life, and 25% renal excretion. ; It has been co-developed by Bristol-Myers Squibb and Pfizer as an anticoagulant and antithrombotic agent in non-valvular atrial fibrillation (NVAF) and venous thromboembolic events (VTE). ; Apixaban was approved in 2014 by the Saudi Food and Drug Authority (SFDA) and the three approved indications include:; ; • Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF) with one or more risk factors.; • Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.; • Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery.; ; Saudi Arabia reported medication errors related with the use of direct oral anticoagulant in clinical practice and highlighted the need for risk prevention and reduction strategies to enhance safety associated with anticoagulant use.; ; As directed by the SFDA, the Marketing Authorization Holder (MAH) agreed to provide educational materials as part of additional risk minimization measures (aRMMs), targeting all healthcare professionals (HCPs) who are expected to prescribe/use Eliquis® for any of the approved indications.; ; This study, therefore, is intended to assess whether implementation of the RM tools has led to effective understanding and reinforcement of key safety messages outlined in the Summary of Product Characteristics (SmPC) and Package Leaflet. ; The MAH has committed to do this using a survey-based approach. The survey will be comprised of questions aimed at assessing the success of RM tool implementation: ; ; • Utilization of the RM tools ; • Knowledge and comprehension of the RM tool key safety messages; • Self-declared behaviors (including hypothetical risk-based scenarios).;
• Study status:
  Planned

Research institutions and networks

Institutions

Pfizer

Networks

IQVIA Saudi Arabia Limited

Study timelines

Date when funding contract was signed

Actual: 26/10/2023

Study start date

Planned: 01/06/2025

Date of final study report

Planned: 30/12/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer Saudi Limited 100% Funding

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only