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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

NCT04444804 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 22153

Last updated 2022-04-28

No results posted yet for this study

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

  • Venous Thromboembolism

Interventions

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

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-31
Primary Completion
2021-04-30
Completion
2021-04-30

Countries

  • Germany

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04444804 on ClinicalTrials.gov