Blood and Lymph Conditions

All Conditions

Neoplasms

Heart and Blood Diseases

Rare Diseases

Myeloproliferative Disorders

Polycythemia Vera

Polycythemia

Thromboembolism

Venous Thromboembolism

Primary Myelofibrosis

Thrombocytosis

Thrombocythemia, Essential

Thrombosis

Embolism

Embolism and Thrombosis

Vascular Diseases

Bone Marrow Diseases

Hematologic Diseases

Bone Marrow Neoplasms

Hematologic Neoplasms

Blood Platelet Disorders

Hemostatic Disorders

Blood Coagulation Disorders

Hemorrhagic Disorders

Chronic Myeloproliferative Disorders

Essential Thrombocythemia

Antipyretics

Anti-Inflammatory Agents

Antirheumatic Agents

Fibrinolytic Agents

Analgesics

Platelet Aggregation Inhibitors

All Drugs and Chemicals

Anticoagulants

Anti-Infective Agents

Amino Acids

Aspirin

Apixaban

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Factor Xa Inhibitors

Antithrombins

Antithrombin III

Protease Inhibitors

Serine Proteinase Inhibitors

HIV Protease Inhibitors

Serine

Patients who are randomized to this group will take a low-dose aspirin 81mg pill once per day (standard-of-care) for at least 6 months along with cytoreductive therapy, if applicable. Patients will then be treated and followed up as per standard of care at the discretion of his or her treating physician after the completion of the study.

Patients who are randomized to this group will receive apixaban 2.5mg twice daily for at least 6 months along with standard intervention, cytoreductive therapy, if applicable. Patients will then be treated and followed up as per standard of care at the discretion of their treating physician after the completion of the study.

2.5mg twice per day for 6 months Then treated \& followed up as per standard of care

Apixaban 2.5 MG Oral Tablet [ELIQUIS]

81mg once per day for 6 months Then treated \& followed up as per standard of care

Aspirin 81 mg

Aurelien Delluc, MD, PhD

Miriam Kimpton, MD

Myeloproliferative neoplasms (MPNs) are blood disorders that occur when the body makes too many white or red blood cells, or platelets. This overproduction of blood cells in the bone marrow can create problems for blood flow and lead to various symptoms. One of the major problems is the formation of blood clots. These may form in the veins of a patient's legs or arms where they cause leg or arm pain, swelling or difficulty walking. These clots may travel to the lung and then cause chest pain, shortness of breath and sometimes death. Blood clots can also lead to poor or no blood flow to one's heart, brain, or other organs, causing damages that cannot be easily or ever repaired, such as stroke or heart attack.

Patients diagnosed with certain types of MPN are associated with a higher risk of developing blood clots and related complications. For this reason, MPN patients are usually treated with low-dose aspirin, a common drug used for blood clot prevention, on long-term basis to prevent the formation of blood clots and other complications. However, recent studies also show that the risk of blood clots remains elevated in MPN patients treated with aspirin, and there may not be improvement or reduction in fatal or other events that are associated with blood clots. In addition, since this medical condition is rare, so there's a lack of studies done with high quality results to help physicians decide the best treatment plan for these patients.

The study drug, apixaban, is a new type of orally-taken blood thinner that has been shown to be effective and safe for prevention and treatment of blood clots in various patient populations. The investigators will evaluate whether apixaban is safer and/or better at preventing blood clots and other complications in MPN patients compared to aspirin.

Assessing Feasibility of Thromboprophylaxis With Apixaban in JAK2-positive Myeloproliferative Neoplasm Patients

A Phase 2 Pilot Randomized Controlled Trial Assessing Feasibility of Thromboprophylaxis With Apixaban in JAK2-positive Myeloproliferative Neoplasm Patients

Feasibility of recruitment efforts will be determined by the proportion of patients contacted for screening versus those who are consented

Feasibility of enrollment will be determined by the proportion of patients consented vs those were enrolled and randomized

This will be defined as the proportion of patients who started study intervention versus those who completed each of the study follow-up visits.

This will be defined as the total number of arterial and venous thrombotic events developed relative to the total number of patients who received study treatment

This will be defined as the total number of adjudicated major bleeding events relative to the total number of patients who received study treatment

This will be defined as the total number of adjudicated non-major clinically relevant bleeding events relative to the total number of patients who received study treatment

This will be defined as the total number of adjudicated deaths relative to the total number of patients who received study treatment

Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network

the Association médicale universitaire de l'Hôpital Montfort (AMUHM)

Canadian Hematology Society

Ottawa Hospital Research Institute

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Neoplasm Metastasis

Pulmonary Embolism

Venous Thrombosis

Lung Diseases

Respiratory Tract Diseases

Pharmaceutical Solutions

Heparin

Edoxaban

Calcium heparin

Heparin, Low-Molecular-Weight

Tinzaparin

Dalteparin

After 5 days of low molecular weight heparin (LMWH), patients receive edoxaban treatment daily - tablet for oral use

Participants receive Dalteparin treatment daily -solution for subcutaneous injection

After the 5 day treatment with LMWH, patients receive edoxaban 60 mg once daily (QD) as 2 × 30 mg tablets (or 1 x 30 mg tablet QD for patients requiring dose adjustment) for the remainder of the treatment period.

Dalteparin was administered via subcutaneous injection at a dose of 200 IU/kg (maximum daily dose 18,000 IU) for 30 days, and at a dose of 150 IU/kg from Day 31 to the end of treatment.

Therapeutic doses of subcutaneous LMWH were administered for at least 5 days (to patients in the edoxaban group); this 5-day period may have included the pre-randomization LMWH (if applicable). The choice of parenteral LMWH was up to the treating physician.

Low molecular weight heparin

Global Clinical Leader

The primary objective is to demonstrate the non-inferiority of edoxaban (preceded by a short course of LMWH) compared with dalteparin for the prevention of the combined outcome of recurrent venous thromboembolism (VTE) or major bleeding in subjects with VTE associated with cancer during a 12-month study period. If non-inferiority is established, LMWH/edoxaban will be compared with dalteparin for superiority.

Cancer Venous Thromboembolism (VTE)

A Phase 3b, Prospective, Randomized, Open-label, Blind Evaluator (PROBE) Study Evaluating the Efficacy and Safety of (LMW) Heparin/Edoxaban Versus Dalteparin in Venous Thromboembolism Associated With Cancer

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

The primary safety endpoint was major bleeding events during the On-Treatment Study Period (defined as on-study drug or up to 3 days after the last dose of study drug).

Daiichi Sankyo

After 5 days of low molecular weight heparin (LMWH), participants received edoxaban treatment daily

Edoxaban Group

Dalteparin Group

Total

Age, Continuous

18-64 Years

65-84 Years

85 years and over

Age, Customized

Sex: Female, Male

White

Black or African American

Asian

Native Hawaiian/Pacific Islander

Other

The number analyzed in rows differs from overall because information was not provided by some participants: 13 in the edoxaban group and 18 in the dalteparin group.

Race/Ethnicity, Customized

Netherlands

Belgium

Hungary

United States

Italy

France

Austria

Germany

Czechia

Spain

Australia

New Zealand

Canada

Region of Enrollment

Solid Tumor

Haematological Malignancy

Solid Tumor and Haematological Malignancy

Type of Cancer

Daiichi Sankyo US Contact for Clinical Trial Results

modified Intent to Treat (mITT), equating to the Safety Analysis Set

Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event

The HR, 2-sided CI and p-value are based on the Cox regression model with counting process approach for on-treatment including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.

Number of Participants With Adjudicated Major Bleeding Events While on Treatment

The HR, 2-sided CI, and p-value are based on the Cox proportional hazard model including treatment and the 2 stratification factors as covariates: the dichotomized bleeding risk and the dichotomized dose-adjustment factor.

Number of Participants With Recurrent Venous Thromboembolism (VTE) During the Overall Study Period

Number of Participants With Recurrent Deep Vein Thrombosis (DVT) During the Overall Study Period

Number of Participants With Recurrent Non-Fatal Pulmonary Embolism (PE) During the Overall Study Period

Number of Participants With VTE-Related Death

Number of Participants With Recurrent VTE, Major Bleed or All-Cause Death

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Rivaroxaban

Dabigatran

Rivaroxaban (Xarelto, BAY59-7939)

Apixaban(Eliquis)

Pradaxa (Dabigatran etexilate)

Patients with cancer are at a significantly increased risk of experiencing a venous thromboembolism (VTE). 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) and is a leading cause of condition of being diseased and death among cancer patients. The goal of the study is to gather information how often venous thromboembolism (VTE) occurs in prostate cancer patients in Sweden and how this condition is treated with blood thinners.

Study to Gather Information How Often Venous Thromboembolism Occurs in Prostate Cancer Patients in Sweden and How This Condition is Treated With Blood Thinners

Prostate Cancer VTE in Sweden: Epidemiology and Anticoagulation Treatment of VTE

Availability of this study's data will 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.

Among men with PCa and a first cancer-related VTE event； To characterize the long-term anticoagulation treatment

Among men with PCa and a first cancer-related VTE event； By long-term anticoagulation treatment (LMWH (Low molecular weight heparin), VKA (Vitamin K anticoagulants) or NOAC (Non-vitamin K oral anticoagulation)) and its estimated duration (up 3 months, 3-6 months, more than 6 months)

Among men with PCa and a first cancer-related VTE event

Among PCa-free men from the general population

Janssen Research & Development, LLC

Bayer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Assessing Feasibility of Thromboprophylaxis With Apixaban in JAK2-positive Myeloproliferative Neoplasm Patients	NCT04243122	Myeloproliferat... Essential Throm... JAK2 Mutation Polycythemia Ve... Primary Myelofi... Venous Thromboe...	Apixaban 2.5 MG... Aspirin 81 mg	18 Years -	Ottawa Hospital Research Institute
Cancer Venous Thromboembolism (VTE)	NCT02073682	Venous Thromboe... Deep Vein Throm... Pulmonary Embol... Cancer	Edoxaban Dalteparin Low molecular w...	18 Years -	Daiichi Sankyo
Assessing Feasibility of Thromboprophylaxis With Apixaban in JAK2-positive Myeloproliferative Neoplasm Patients	NCT04243122	Myeloproliferat... Essential Throm... JAK2 Mutation Polycythemia Ve... Primary Myelofi... Venous Thromboe...	Apixaban 2.5 MG... Aspirin 81 mg	18 Years -	Ottawa Hospital Research Institute
Study to Gather Information How Often Venous Thromboembolism Occurs in Prostate Cancer Patients in Sweden and How This Condition is Treated With Blood Thinners	NCT03965741	Venous Thromboe...	Rivaroxaban (Xa... Apixaban(Eliqui... Pradaxa (Dabiga...	-	Bayer
Assessing Feasibility of Thromboprophylaxis With Apixaban in JAK2-positive Myeloproliferative Neoplasm Patients	NCT04243122	Myeloproliferat... Essential Throm... JAK2 Mutation Polycythemia Ve... Primary Myelofi... Venous Thromboe...	Apixaban 2.5 MG... Aspirin 81 mg	18 Years -	Ottawa Hospital Research Institute

Spots Global Cancer Trial Database for venous thromboembolism (vte)