(1/2) Statins to Prevent Cancer Associated Venous Thromboembolism (STAT-CAT): CCC

STAT-CAT Project Summary / Abstract (maximum 30 lines) Oncology patients are at high risk for life-threatening venous thromboembolism (VTE) yet rarely receive anticoagulant prophylaxis due to bleeding risks. Thus, effective prophylaxis in oncology requires a method to reduce VTE without increasing hemorrhage. The primary aim of the proposed Statins to Prevent Cancer Associated Venous Thromboembolism (STAT-CAT) trial is to test whether rosuvastatin 20 mg daily for 12 months compared to placebo can safely prevent VTE in patients with newly diagnosed or recently relapsed cancer who are at increased thrombotic risk, are not planned to be anticoagulated, and who neither take nor otherwise qualify for statin therapy. Randomized trial data strongly support the core STAT-CAT hypothesis; as independently demonstrated in both the large-scale JUPITER and HOPE-3 trials, random allocation to rosuvastatin as compared to placebo resulted in a 47% reduction in VTE risk (HR 0.53, 95%CI 0.37-0.75) without any increase in bleeding. STAT-CAT is also supported by mechanistic studies which demonstrate decreased prothrombotic potential in those taking rosuvastatin through lipid independent pathways that include anti-inflammatory effects. STAT- CAT will enroll up to 4000 participants with recently diagnosed or relapsed cancer who have moderate- to-high VTE risk using an innovative pre-screening computable phenotype tool that will efficiently enable study coordinators to electronically pre-define potential trial participants at all sites in an identical manner while reducing subjectivity and enhancing applicability and generalizability. STAT-CAT will enroll through a proven “hub-and-spoke” engagement plan with committed high-volume academic cancer centers who have strong community partnerships to ensure a broad and generalizable tumor base with adequate representation of both sexes and of underrepresented populations; these sites see more than 75,000 STAT-CAT eligible patients annually. The primary endpoint of STAT-CAT is the incidence of pulmonary embolus, deep vein thrombosis of the upper or lower extremities, or fatal VTE during 12 months of active therapy or matching placebo. Secondary and tertiary aims include the impact of rosuvastatin on the composite rate of venous and arterial thrombosis, as well as evaluating safety with a focus on bleeding, transaminitis and myositis. Streamlined trial operations and pragmatic participant follow-up assessments will be used to minimize site burden while allowing virtually all other trial activities, including drug delivery, to be performed centrally in a consistent and cost-efficient manner. We believe the likelihood is high that generic rosuvastatin can significantly reduce rates of VTE in an oncology setting with no increase in bleeding; if successful, STAT-CAT will markedly improve thrombotic outcomes for large numbers of oncology patients with a safe and inexpensive intervention that avoids the hemorrhagic complications of conventional anticoagulation. Project Number: 1UG3HL176627-01A1 | Fiscal Year: 2025 | NIH Institute/Center: National Heart Lung and Blood Institute (NHLBI) | Principal Investigator: Paul Ridker (+2 co-PIs) | Institution: BRIGHAM AND WOMEN'S HOSPITAL, BOSTON, MA | Award Amount: $2,290,286 | Activity Code: UG3 | Study Section: Clinical Trials Review Study Section[CLTR (MA)] View on NIH RePORTER: https://reporter.nih.gov/project-details/1UG3HL17662701A1