Study type

Study topic

DiseaseĀ /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Effectiveness study (incl. comparative)

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(B01AA03) warfarin
warfarin
(B01AB01) heparin
heparin
(B01AF01) rivaroxaban
rivaroxaban
(B01AX05) fondaparinux
fondaparinux

Medical condition to be studied

Pulmonary venous thrombosis
Embolism venous
Population studied

Short description of the study population

The source population of this study will include all insured members of more than 60 German statutory health insurances (SHIs) contributing data to the InGef database.

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Special population of interest

Renal impaired

Estimated number of subjects

25000
Study design details

Main study objective

The primary objective of this study is to assess the risk of recurrent venous thromboembolic (VTE) events in VTE patients treated with rivaroxaban compared to patients treated with low-molecular-weight heparin (LMWH) and phenprocoumon

Outcomes

The effectiveness outcome, recurrent VTE will be analyzed (primary objective) as primary outcome. Safety outcomes include fatal bleeding (secondary objective), and end stage renal disease (other objectives)

Data analysis plan

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.