Study to Identify and Describe Predictive Factors for Thromboembolic Events in Patients With High-risk Polycythemia Vera
Key claim: This prospective observational study aims to identify and characterize predictive factors for thromboembolic events in patients with high-risk polycythemia vera who have experienced at least one such event.
Abstract
This is a prospective observational study that will enroll patients with high-risk Polycythemia Vera (PV) with at least one Thromboembolic Event (TE) after diagnosis or up to 2 years prior to diagnosis.
This is a non-randomized study, and to ensure a sufficient number of patients in both cohorts, enrollment in each cohort will be terminated once the target of 150 patients has been reached.
Why this matters
Thrombosis is the dominant driver of morbidity and mortality in high-risk PV, yet current risk stratification relies on coarse age/prior-event criteria that fail to discriminate within the already-thrombosed high-risk population. A prospective observational design focused on secondary-prevention predictors could yield PV-specific biomarkers (clinical, molecular, or hemorheologic) to refine recurrence risk and complement parallel anticoagulation trials such as AVAJAK in this subtype.