Trial NCT07303816
Statins to Prevent Cancer Associated Blood Clots
- Phase
- Phase 4
- Sponsor
- Brigham and Women's Hospital
- Conditions
- Venous Thromboembolism; Cancer; Cardiovascular Events
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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 0-2Performance status
* 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 lymphomaBrain metastases, 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/1.73m2Renal, or Child Pugh Class B or C liver diseaseHepatic
* Known hepatitis C or HIV diseaseHIV, 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.
Restrictions found (5)
- Brain metastasesOutrightexclusionShow in the text
- HepaticOutrightexclusion
Child Pugh Class B or C
Show in the text - HIVOutrightexclusionShow in the text
- Performance statusOutrightinclusion
ECOG 0-2
Show in the text - RenalOutrightexclusion
eGFR < 30 ml/min/1.73m2
Show in the text
Recruiting in Massachusetts
- Beth Isreal Deaconess Medical Center · Boston, Suffolk County
- Dana-Farber Cancer Institute · Boston, Suffolk County