Observational Studies in Cancer Associated Thrombosis for Rivaroxaban - United States Cohort

NCT ID: NCT04979780

Last Updated: 2024-10-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3708 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-20
• Study Completion Date: 2022-03-31

Brief Summary

Patients with active cancer are ~5-fold more likely to develop a venous thromboembolism (VTE) than those without. When VTE occurs, cancer patients carry an up to a 3-fold higher rate of thrombosis recurrence and ~twice the risk of bleeding during anticoagulation. Therefore, it is critical to utilize anticoagulants that optimize efficacy while minimizing bleeding risk when treating cancer-associated thrombosis (CAT).

Guidelines list direct-acting oral anticoagulants (DOACs) as an alternative to low molecular-weight heparin (LMWH) for treatment of CAT. The strength-of-recommendation for DOACs is based on data from multiple randomized controlled trials (RCTs) comparing them to LMWHs to treat CAT, with results suggesting DOACs may reduce thrombosis risk but with potentially more frequent bleeding (particularly in those with certain gastrointestinal and genitourinary cancers).

Observational studies evaluating DOACs for CAT treatment have been published, but these studies have been either single-arm, evaluated cancer subtypes not recommended for DOAC treatment, were of limited sample size and/or employed heterogeneous definitions of active cancer. We seek to evaluate the effectiveness and safety of rivaroxaban versus LMWH for CAT treatment in active cancer patients using a large de-identified electronic health record database.

Retrospective cohort analysis using US Optum® De-Identified EHR data. We will use Optum EHR (electronic health records) data from November January 1, 2012 through latest available data (currently September 2020).

Conditions

Treatment of Venous Thromboembolism in Cancer Patients; Prophylaxis of Recurrent Venous Thromboembolism in Cancer Patients

Study Design

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

Study Groups

Cancer patients with acute venous thromboembolism (VTE)

Cancer-associated thrombosis (CAT) patients treated with Rivaroxaban or any DOAC (Direct Oral Anticoagulants) or LMWH (Low molecular weight heparin).

Rivaroxaban (Xarelto, BAY59-7939)

Intervention Type: DRUG

Retrospective cohort analysis using US Optum De-Identified EHR data.

Low molecular weight heparin (LMWH)

Intervention Type: DRUG

Retrospective cohort analysis using US Optum De-Identified EHR data. LMWH (dalteparin, enoxaparin, tinzaparin)

Direct Oral Anticoagulants (DOAC)

Intervention Type: DRUG

Retrospective cohort analysis using US Optum De-Identified EHR data. DOAC (apixaban, dabigatran, edoxaban, rivaroxaban).

Interventions

Rivaroxaban (Xarelto, BAY59-7939)

Retrospective cohort analysis using US Optum De-Identified EHR data.

Intervention Type: DRUG

Low molecular weight heparin (LMWH)

Retrospective cohort analysis using US Optum De-Identified EHR data. LMWH (dalteparin, enoxaparin, tinzaparin)

Intervention Type: DRUG

Direct Oral Anticoagulants (DOAC)

Retrospective cohort analysis using US Optum De-Identified EHR data. DOAC (apixaban, dabigatran, edoxaban, rivaroxaban).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Be ≥18 years of age at the time of anticoagulation initiation.
• Have active cancer admitted to the hospital, emergency department or observation unit for acute DVT and/or PE.
• Treated with rivaroxaban (or any DOAC in secondary analysis) or LMWH as their first anticoagulant on day 7 post-acute CAT event diagnosis (index date) o increase the probability of accurately classifying patients' intended outpatient anticoagulant for CAT treatment and that patients are compared at the same point from diagnosis.
• Have been active in the data set for at least 12-months prior to the index event (based on the "First Month Active" field) and had at least one provider visit in the 12-months prior to the acute VTE event (baseline period).

Exclusion Criteria

• Evidence of atrial fibrillation, recent hip/knee replacement (within 35 days of index VTE), ongoing VTE treatment, valvular heart disease defined as any rheumatic heart disease, mitral stenosis, or mitral valve repair/replacement.
• Pregnancy.
• Initiation of rivaroxaban at a dose other than 15 mg twice daily or non-therapeutic doses of other DOAC or LMWH (e.g., enoxaparin at a dose other than 1 mg/kg twice daily or 1.5 mg/kg once daily; dalteparin at a dose other than 200 IU/kg of total body weight)
• Evidence of use of anticoagulation use during the 12-months prior per written prescription or patient self-report

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

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Many Locations

Multiple Locations, Connecticut, United States

Countries

United States

References

Caroti KS, Becattini C, Carrier M, Cohen AT, Ekbom A, Khorana AA, Lee AYY, Brescia C, Abdelgawwad K, Psaroudakis G, Rivera M, Schaefer B, Brobert G, Coleman CI. Rivaroxaban versus Apixaban for Treatment of Cancer-Associated Venous Thromboembolism in Patients at Lower Risk of Bleeding. TH Open. 2023 Jul 10;7(3):e206-e216. doi: 10.1055/s-0043-1770783. eCollection 2023 Jul.

Reference Type: BACKGROUND

PMID: 37435565 (View on PubMed)

Coleman CI, Caroti KS, Abdelgawwad K, Psaroudakis G, Fatoba S, Rivera M, Schaefer B, Brobert G, Khorana AA, Becattini C, Lee AYY, Ekbom A, Carrier M, Brescia C, Cohen AT. Effectiveness and Safety of Rivaroxaban and Low Molecular Weight Heparin in Cancer-Associated Venous Thromboembolism. JACC CardioOncol. 2023 Feb 7;5(2):189-200. doi: 10.1016/j.jaccao.2022.10.014. eCollection 2023 Apr.

Reference Type: DERIVED

PMID: 37144109 (View on PubMed)

Related Links

https://clinicaltrials.bayer.com/study/21982

Click here to find further information and, after study completion, the study results according to Bayer's transparency standards

Other Identifiers

21982

Identifier Type: -

Identifier Source: org_study_id