Trials / Completed
CompletedNCT04444804
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
Real-world Comparative Effectiveness of Rivaroxaban Versus Low-molecular-weight Heparin (LMWH) and Phenprocoumon for the Treatment and Secondary Prevention of Venous Thromboembolism (RECENT)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 22,153 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 thromboembolism by evaluating routine clinical practice data from research database in Germany. VTE is defined by a blood clot in the leg or lower extremity (deep vein thrombosis) or a blood clot in the lung (pulmonary embolism). Treatment of VTE traditionally consists of acute anticoagulation treatment with heparin (mainly LMWH), followed by maintenance oral anticoagulation with vitamin-K antagonists (in Germany mainly phenprocoumon). Rivaroxaban, a direct-acting oral anticoagulants (DOAC), is an alternative VTE treatment and has been approved for both the acute and maintenance phase of VTE treatment. The study will enroll adult male or female patients who are newly diagnosed with VTE and are already on the treatment with Rivaroxaban or LMWH and phenprocoumon. Researchers are especially interested whether patients experience under treatment any VTE events or fatal bleedings.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rivaroxaban (Xarelto, BAY 59-7939) | Dosage at the discretion of the treating physician |
| DRUG | LMWH and Phenprocoumon | Dosage at the discretion of the treating physician |
Timeline
- Start date
- 2020-07-31
- Primary completion
- 2021-04-30
- Completion
- 2021-04-30
- First posted
- 2020-06-24
- Last updated
- 2022-04-28
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT04444804. Inclusion in this directory is not an endorsement.