Status:
COMPLETED
Study to Compare the Effectiveness of Rivaroxaban (Xarelto) Versus Low-molecular-weight Heparin (LMWH) and Phenprocoumon for the Treatment and Secondary Prevention of Venous Thromboembolism in Routine Clinical Practice in Germany
Lead Sponsor:
Bayer
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
18+ years
Brief Summary
Researcher in this study want to compare the effectiveness of Rivaroxaban (Xarelto) versus low-molecular-weight heparin (LMWH) and phenprocoumon for the treatment and secondary prevention of venous th...
Eligibility Criteria
Inclusion
- At least one new diagnosis of VTE during the inclusion period:
- Ambulatory diagnosis, coded as verified,
- Primary hospital discharge diagnosis.
- Secondary hospital discharge diagnosis The quarter of the first VTE diagnosis in the inclusion period will be defined as the index quarter. For hospital diagnoses, the date of admission will be used to define the index quarter.
- The 12 months prior to the index date will define the baseline period for all included patients. Patients treated with anticoagulation regimens other than defined above (e.g. other DOACs) will not be included in the study. All patients will have to fulfill the additional inclusion criteria:
- Continuous enrolment in the baseline period
- ≥ 18 years of age at index date
Exclusion
- A verified ambulatory or primary/ secondary hospital discharge diagnosis of VTE in the baseline period;
- A verified ambulatory or primary/ secondary hospital discharge diagnosis of atrial fibrillation in the baseline period; Individuals with documented cardiac valve surgery in the baseline period;
- A verified ambulatory or primary/ secondary hospital discharge diagnosis indicating pregnancy in the baseline period;
- A prescription of any anticoagulation treatment (heparins; vitamin-K antagonists; rivaroxaban; other DOACs) in the baseline period;
- A verified ambulatory or primary/ secondary hospital discharge diagnosis of end-stage kidney disease or a claim for dialysis in the baseline period;
- A prescription of contraindicated drug for rivaroxaban due to drug interactions (i.e. azole antifungals and HIV protease inhibitors) in the 60 days before or on the index date.
- Patients assigned to rivaroxaban exposure groups who were initially treated with a dose strength other than 15 mg or 20 mg per tablet.
Key Trial Info
Start Date :
July 31 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 30 2021
Estimated Enrollment :
22153 Patients enrolled
Trial Details
Trial ID
NCT04444804
Start Date
July 31 2020
End Date
April 30 2021
Last Update
April 28 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Multiple facilities
Multiple Locations, Germany