Trial Condition(s):
Atrial Fibrillation
Real-world comparative effectiveness of stroke prevention in patients with atrial fibrillation treated with rivaroxaban vs. vitamin k antagonists
Bayer Identifier:
18735
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
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.
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]
Trial Summary
Enrollment Goal
99999
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No
Where to Participate
Loading...
Locations
Status
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many Locations, Germany | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Real-world comparative effectiveness of stroke prevention in patients with atrial fibrillation treated with rivaroxaban vs. vitamin k antagonists
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
2
Primary Outcome
- Risk of ischemic stroke estimated as the number of hospitalizations with the ICD-10-GM diagnosisTimeframe: Within time of drug exposure (Retrospective period of 5 years and 3 months)
- Risk of intracranial hemorrhage (ICH) estimated as the number of hospitalizations with the ICD-10-GM diagnosisTimeframe: Within time of drug exposure (Retrospective period of 5 years and 3 months)
Secondary Outcome
- Risk of ischemic stroke or ICH estimated as the number of hospitalizations with the respective ICD-10-GM diagnosisTimeframe: Within time of drug exposure (Retrospective period of 5 years and 3 months)
- Risk of systemic embolism (SE) estimated as the number of hospitalizations with the ICD-10-GM diagnosisTimeframe: Within time of drug exposure (Retrospective period of 5 years and 3 months)
- Risk of transient ischemic attack (TIA) estimated as the number of hospitalizations with the ICD-10-GM diagnosisTimeframe: Within time of drug exposure (Retrospective period of 5 years and 3 months)
- Risk of ischemic stroke or SE or TIA estimated as the number of hospitalizations with the respective ICD-10-GM diagnosisTimeframe: Within time of drug exposure (Retrospective period of 5 years and 3 months)
Additional Information
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