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 | Completed

• 1 other identifier: 21456
• Study Type: observational
• Target: 22,153
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Risk of recurrent venous thromboembolic (VTE) events in VTE patients treated with rivaroxaban compared to patients treated with LMWH and Phenprocoumon

  A recurrent VTE event will be defined as a hospitalization with a primary hospital discharge diagnoses for VTE for which the admission date was \>14 days after the index date. Non-interventional retrospective cohort study based on German claims data from the InGef (Institute for Applied Healthcare Research Berlin) research database between January 2013 and December 2018.

  Retrospective data from January 2013 to December 2018

Secondary Outcomes (1)

• Risk of fatal bleeding in VTE patients treated with rivaroxaban compared to patients treated with LMWH and Phenprocoumon

  Retrospective data from January 2013 to December 2018

Study Arms (2)

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.

Drug: Rivaroxaban (Xarelto, BAY 59-7939)

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.

Drug: LMWH and Phenprocoumon

Interventions

Rivaroxaban (Xarelto, BAY 59-7939) DRUG

Dosage at the discretion of the treating physician

Rivaroxaban

LMWH and Phenprocoumon DRUG

Dosage at the discretion of the treating physician

Low-molecular-weight heparin (LMWH) and Phenprocoumon

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Ambulatory diagnosis, coded as verified,
• Primary hospital discharge diagnosis.
• Continuous enrolment in the baseline period
• ≥ 18 years of age at index date

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Multiple facilities

Multiple Locations, Germany

Location

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Rivaroxaban; Heparin, Low-Molecular-Weight; Phenprocoumon

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 24, 2020
• Study Start: July 31, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: April 28, 2022

Record last verified: 2022-04

Locations

DE (1)