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

NCT ID: NCT04444804

Last Updated: 2022-04-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 22153 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-31
• Study Completion Date: 2021-04-30

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 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Rivaroxaban

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.

Rivaroxaban (Xarelto, BAY 59-7939)

Intervention Type: DRUG

Dosage at the discretion of the treating physician

Low-molecular-weight heparin (LMWH) and Phenprocoumon

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.

LMWH and Phenprocoumon

Intervention Type: DRUG

Dosage at the discretion of the treating physician

Interventions

Rivaroxaban (Xarelto, BAY 59-7939)

Dosage at the discretion of the treating physician

Intervention Type: DRUG

LMWH and Phenprocoumon

Dosage at the discretion of the treating physician

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.
• Continuous enrolment in the baseline period
• ≥ 18 years of age at index date

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Multiple facilities

Multiple Locations, , Germany

Countries

Germany

Other Identifiers

21456

Identifier Type: -

Identifier Source: org_study_id