Statins to Prevent Cancer Associated Blood Clots
Recruiting · NCT07303816 · Interventional (participants receive a specific treatment) · Lead sponsor: Brigham and Women's Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Patients with cancer 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 Statin Therapy 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 do not otherwise take statin therapy.
Who can take part
Inclusion criteria
- age \> 18 years with no contraindication to statin therapy and able to provide informed consent
- newly diagnosed, newly recurrent or newly progressive malignancy with locally advanced/metastatic disease initiating new systemic cancer therapy with no plan for prophylactic anticoagulation.
- intermediate or high risk for cancer associated VTE based on the Khorana Score (KS) and modified Khorana Score (mKS) risk assessment tools (KS 2-4 or mKS 2-5).
- ECOG performance status 0-2
- Life expectancy \> 6 months
Exclusion criteria
- current use of statin therapy or known statin intolerance.
- current use of systemic anticoagulation.
- very low VTE risk defined by a Khorana Score (KS) of 0-1 and a modified Khorana Score (mKS) of 0-1.
- extremely high VTE risk defined by a Khorana Score (KS) \> 5 or modified Khorana Score (mKS) \> 6 where guideline recommendations for systemic anticoagulation should be considered.
- Basal cell or squamous cell carcinoma in situ cancers of the skin as the sole qualifying cancer type
- ineligible cancer types where level of acuity is likely to preclude trial participation (including acute leukemia, myelodysplastic syndromes, primary brain tumors, primary CNS lymphoma, or plans to undergo hematopoietic stem cell transplantation or CAR-T cell therapy). (g) Known ALT, AST, or creatine kinase (CK) levels \> 3 x ULN; eGFR \< 30 ml/min/1.73m2, or Child Pugh Class B or C liver disease
- Known hepatitis C or HIV disease, or intent to use certain oncologic agents (daralutemide, regorafenib, and cabozantinib) or some antivirals used to treat hepatitis C or HIV disease (combinations of sofosbuvir, velpatasvir, and voxilaprevir) which can significantly increase rosuvastatin exposure and potentially lead to drug-drug interactions (DDIs).
- Conditions that, in the opinion of the investigator, would compromise the well-being of the subject or conduct of the study, including as examples life expectancy less than 6 months or an ECOG Performance Status \> 3.
Where it is running
9 locations listed across 7 US states.
- City of Hope - Irvine, California, United States
- Yale University - New Haven, Connecticut, United States
- University of Miami - Miami, Florida, United States
- Beth Isreal Deaconess Medical Center - Boston, Massachusetts, United States
- Brigham and Women's Hospital - Boston, Massachusetts, United States
- Dana-Farber Cancer Institute - Boston, Massachusetts, United States
- Mayo Clinic - Rochester, Minnesota, United States
- Cleveland Clinic Foundation - Cleveland, Ohio, United States
- The University of Texas MD Anderson Cancer Center - Houston, Texas, United States