Symptoms and General Pathology

All Conditions

Heart and Blood Diseases

Recurrence

Thrombosis

Thromboembolism

Venous Thromboembolism

Embolism

Embolism and Thrombosis

Vascular Diseases

Fibrinolytic Agents

Anticoagulants

All Drugs and Chemicals

Anti-Infective Agents

Amino Acids

Heparin

Enoxaparin

Edoxaban

Rivaroxaban

Apixaban

Dabigatran

Calcium heparin

Heparin, Low-Molecular-Weight

Tinzaparin

Dalteparin

Enoxaparin sodium

Factor Xa Inhibitors

Antithrombins

Antithrombin III

Protease Inhibitors

Serine Proteinase Inhibitors

HIV Protease Inhibitors

Enzyme Inhibitors

Serine

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

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

Rivaroxaban (Xarelto, BAY59-7939)

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

Low molecular weight heparin (LMWH)

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

Direct Oral Anticoagulants (DOAC)

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).

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

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Cunningham algorithm for identification of bleeding-associated hospitalizations

including:

* Intracranial hemorrhage (ICH)
* Critical organ bleeding (e.g., intracranial, intraspinal, intraocular, retroperitoneal, intraarticular, or pericardial bleeding or intramuscular with compartment syndrome)
* Extracranial bleeding-related hospitalizations

per the Cunningham algorithm for identification of bleeding-associated hospitalizations

Incidence rates of recurrent VTE in DOAC and LMWH patients experiencing CAT regardless of the bleeding risk associated with cancer type.

Incidence rates of any clinically-relevant bleeding-related in DOAC and LMWH patients experiencing CAT regardless of the bleeding risk associated with cancer type.

Incidence rates of all cause-mortality in DOAC and LMWH patients experiencing CAT regardless of the bleeding risk associated with cancer type.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Observational Studies in Cancer Associated Thrombosis for Rivaroxaban - United States Cohort	NCT04979780	Treatment of Ve... Prophylaxis of ...	Rivaroxaban (Xa... Low molecular w... Direct Oral Ant...	18 Years -	Bayer
Observational Studies in Cancer Associated Thrombosis for Rivaroxaban - United States Cohort	NCT04979780	Treatment of Ve... Prophylaxis of ...	Rivaroxaban (Xa... Low molecular w... Direct Oral Ant...	18 Years -	Bayer

Spots Global Cancer Trial Database for direct oral anticoagulants (doac)