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

Digestive System Diseases

Nervous System Diseases

Symptoms and General Pathology

Hypertension

Hypertension, Portal

Varicose Veins

Hemangioma, Cavernous

Hemangioma

Esophageal and Gastric Varices

Liver Diseases

Gastrointestinal Diseases

Esophageal Diseases

Neoplasms, Vascular Tissue

Neoplasms by Histologic Type

Syndrome

Brain Diseases

Central Nervous System Diseases

Patients with portal caver cavernoma and gastroesophageal varices and JAK2 Mutation.

Patients with portal caver cavernoma and gastroesophageal varices without JAK2 Mutation.

Patients with portal caver cavernoma will be divided into two groups by the result of JAK2 mutation test

JAK2 mutation test

Xiaoquan HUANG, M.D.

Myeloproliferative neoplasms (MPNs), including polycythemia vera, essential thrombocythemia, and primary myelofibrosis, may lead to gastroesophageal varices. The quality of life, morbidity, and mortality of MPN patients mainly depend on disease-related symptoms, thromboembolic and hemorrhagic complications. Previous studies have shown that JAK2 V617F has a prominent role in vascular risk and MPN-associated gastroesophageal varices. Portal vein thrombosis and portal cavernoma frequently occur in the MPN population and the management of gastroesophageal varices in these patients are sometimes technically difficult. The aim of this study is to investigate the the characteristics of patients with gastroesophageal varices and portal caver cavernoma with or without JAK2 mutation.

Gastroesophageal Varices in Cavernoma

Characteristic of Patients With Gastroesophageal Varices and Portal Cavernoma

Have a history of the occurrence of gastroesophageal variceal bleeding

The concurrence of complications of portal hypertension (ascites, infections, variceal bleeding, et al)

Shanghai Zhongshan Hospital

Resident

Heparin

Warfarin

Rivaroxaban

Calcium heparin

Heparin, Low-Molecular-Weight

Tinzaparin

Dalteparin

Patients with JAK2 mutation and gastroesophageal varices receive anticoagulation agents.

Patients with JAK2 mutation and gastroesophageal varices who didn't receive anticoagulation agents.

Patients receive anticoagulation agents including low molecular weight heparin, warfarin, rivaroxaban, et al.

Anticoagulation Agents

Xiaoquan HUANG, Ph.D

Myeloproliferative neoplasms (MPNs), including polycythemia vera, essential thrombocythemia, and primary myelofibrosis, may lead to gastroesophageal varices. The quality of life, morbidity, and mortality of MPN patients mainly depend on disease-related symptoms, thromboembolic and hemorrhagic complications. Previous studies have shown that JAK2 V617F has a prominent role in vascular risk and MPN-associated gastroesophageal varices. The aim of this study is to evaluate the efficacy of anticoagulation in patients with JAK2 mutation and gastroesophageal varices.

Anticoagulation in Gastroesophageal Varices and JAK2 Mutation

Anticoagulation Treatment of Patients With Gastroesophageal Varices and JAK2 V617 Mutation

The changes of portal vein thrombosis including progression, disappear or unchanged.

The occurrence of variceal bleeding including haematemesis and melena

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
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
Gastroesophageal Varices in Cavernoma	NCT04525768	Gastroesophagea... Myeloproliferat... Portal Caver Ca... Portal Hyperten...	JAK2 mutation t...	18 Years - 75 Years	Shanghai Zhongshan Hospital
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
Anticoagulation in Gastroesophageal Varices and JAK2 Mutation	NCT04527666	Gastroesophagea... JAK2 Mutation Myeloproliferat...	Anticoagulation...	18 Years - 75 Years	Shanghai Zhongshan Hospital

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