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Search / Trial NCT05116267

Assessment of the Effectiveness and Safety Outcome in Patients With Atrial Fibrillation Treated by Apixaban in Belgium

Launched by PFIZER · Nov 2, 2021

Trial Information

Current as of June 03, 2025

Withdrawn

Keywords

Non Valvular Atrial Fibrillation Belgium Apixaban Nvaf

ClinConnect Summary

Apixaban is an antithrombotic agent that directly inhibits factor Xa, and which has obtained market authorization in the indication "prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA), age ≥75 years, hypertension, diabetes mellitus, and symptomatic heart failure (NYHA ≥ class II)." Among other direct oral anti-coagulants (DOACs) only apixaban has shown a triple beneficial profile (on stroke/systemic embolisms, major bleedings, and all-cause mortality) suppo...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • is 18 years or older at the index date.
  • had ≥1 apixaban prescription during the study period from January 1st, 2015 to December 31, 2019.
  • had ≥1 medical diagnosis for Atrial Fibrillation, AF (International Classification of Diseases, 10th Revision, Clinical Modification \[ICD-10-CM\]10 diagnosis codes I48.0, I48.1X, I48.11, I48.19, I48.2X, I48.20, I48.21, I48.9X, I48.91, I49.1) any time before or on index date
  • had \>1 encounter (visits, prescriptions, etc) within the EHRs.
  • Exclusion Criteria:
  • Medical EHRs indicating a diagnosis code indicative of rheumatic mitral valvular heart disease, mitral valve stenosis (ICD-10-CM diagnosis codes I05.x, I06.x, I07.x, I08.x, I34.x, I35.x, I36.x, I37.x, I38.x, I39.x, I37.x, Q23.x) during the 12-month baseline period,
  • Medical EHRs indicating a diagnosis code of VTE (DVT: ICD-10-CM codes: I80.xx, I81.xx, I82.xx, I82.40x, I82.41x, I82.42x, I82.43x, I82.44x, I82.49x, I82.4Yx, I82.4Zx, I82.5xx, I82.51x, I82.52x, I82.53x, I82.54x, I82.55x, I82.56x, I82.59x, I82.5Yx, I82.5Zx, I82.62x, I82.72x, O22.0x, O22.2x, O22.3x; or PE: ICD-10-CM codes I26.01, I26.02, I26.09, I26.90, I26.92, I26.93, I26.94, I26.99) during the 12-month baseline period,
  • Medical EHRs indicating a diagnosis (ICD-10-CM) or procedure code (International Classification of Diseases, 10th Revision, Procedure Coding System \[ICD-10-PCS\]10) of transient AF, or cardiac surgery: Heart valve replacement/transplant: 02YA0Zxx, 02RF0xx, 02RJ0xx, 02RG0xx, 02RH0xx, Z95.2, Z95.3, Z95.4; Pericarditis: I00, I01, I02, I24.1, I30.x, I31.x, I32\*coding first the associated cause/etiology; Hyperthyroidism and Thyrotoxicity: E05.0, E05.1, E05.2, E05.3, E05.4, E05.8, E05.9) during the 12-month baseline period;
  • Medical EHRs indicating pregnancy during the study period (ICD-10-CM diagnosis codes O00-O9A, Z31, Z32, Z33, Z34, Z36, Z37, Z38, O20-O29, ICD-10 CPS code 109xxx, 10Axxx, 10Dxxx, 10Exxx, 10Hxxx, 10Pxxx, 10Sxxx);
  • Medical EHRs indicating diagnosis or procedure for hip/knee replacement surgery within 6 weeks prior to index date (0SR90xx, 0SRA0xx, 0SRB0xx, 0SRC0xx, 0SRD0xx, 0SRE0xx, 0SQ0xx, 0SQB0xx, 0SQB0xx, 0SQB0xx)
  • Patients with a prescription for \>1 anticoagulants at index date.

About Pfizer

Pfizer Inc. is a global leader in biopharmaceutical innovation, dedicated to discovering, developing, and delivering advanced therapies that enhance patient outcomes across a wide range of medical conditions. With a rich history of scientific research and a commitment to quality, Pfizer focuses on areas such as oncology, immunology, cardiology, and rare diseases. The company leverages cutting-edge technology and collaborates with healthcare professionals, regulatory bodies, and academic institutions to conduct rigorous clinical trials that ensure the safety and efficacy of its products. Pfizer's mission is to bring breakthroughs that change patients' lives, exemplifying its commitment to health and wellness worldwide.

Locations

Brussels, , Belgium

Patients applied

0 patients applied

Trial Officials

Pfizer CT.gov Call Center

Study Director

Pfizer

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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