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OpenTrials
Completed

NCT Number: NCT02960880

Real-world Comparative Effectiveness of Stroke Prevention in Patients With Atrial Fibrillation Treated With Rivaroxaban vs. Vitamin k Antagonists

The aim of this study is to assess the real world comparative effectiveness of Rivaroxaban prescribed in non-valvular atrial fibrillation (NVAF) routine care patients in Germany.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • First dispense date of Rivaroxaban (15mg or 20mg - PZN based) or Phenprocoumon (PZN based) between January 1, 2012 and December 31, 2015
  • At least two verified outpatient diagnoses or one inpatient diagnosis (main or secondary diagnosis) of NVAF (ICD-10 GM I48.0/I48.1/I48.2/I48.9) in the individual time frame of 4 quarters before the index date (pre-index period) or within the index quarter
  • Patients will be required to have 4 quarters of enrollment for the assessment of baseline characteristics and be observable and insured in the database for at least one day after their individual index date (post-index period)
  • ≥ 18 years of age

Exclusion criteria

  • Patients with valvular AF [4 quarters prior to the index date]
  • Pregnancy [4 quarters prior to index date]
  • Malignant cancers [4 quarters prior to the index date or "condition after"]
  • Transient cause of AF [4 quarters prior to index date]
  • Patients with VTE (pulmonary embolism or DVT) [60 days before index]
  • Patients with major surgery defined as hip or knee replacement [60 days before index]
  • Prescriptions of OACs (Rivaroxaban, VKA, Dabigatran, Apixaban) before index date [4 quarters prior to index date]
  • Patients receiving more than one anticoagulant substance (Apixaban, Dabigatran, Rivaroxaban or Phenprocoumon) or more than one dosage of a substance on the index date
  • For sensitivity analysis : Patient with any of the events defined in the combined endpoints [4 quarters prior to index date or "condition after"
  • Patients with dialysis [4 quarters prior to index date]

Treatment and study plan

Rivaroxaban (Xarelto, BAY597939)

Drug

15mg, 20mg

Phenprocoumon (branded and generics)

Drug

Individually adjusted dose

Primary outcomes

  1. Risk of ischemic stroke estimated as the number of hospitalizations with the ICD-10-GM diagnosis

    Time frame: Within time of drug exposure (Retrospective period of 5 years and 3 months)

  2. Risk of intracranial hemorrhage (ICH) estimated as the number of hospitalizations with the ICD-10-GM diagnosis

    Time frame: Within time of drug exposure (Retrospective period of 5 years and 3 months)

Secondary outcomes

  1. Risk of ischemic stroke or ICH estimated as the number of hospitalizations with the respective ICD-10-GM diagnosis

    Time frame: Within time of drug exposure (Retrospective period of 5 years and 3 months)

  2. Risk of systemic embolism (SE) estimated as the number of hospitalizations with the ICD-10-GM diagnosis

    Time frame: Within time of drug exposure (Retrospective period of 5 years and 3 months)

  3. Risk of transient ischemic attack (TIA) estimated as the number of hospitalizations with the ICD-10-GM diagnosis

    Time frame: Within time of drug exposure (Retrospective period of 5 years and 3 months)

  4. Risk of ischemic stroke or SE or TIA estimated as the number of hospitalizations with the respective ICD-10-GM diagnosis

    Time frame: Within time of drug exposure (Retrospective period of 5 years and 3 months)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Nov 10, 2016
Registry last updated
Dec 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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