Rosuvastatin to help prevent blood clots in cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 4 trial evaluating rosuvastatin 20 mg once daily for 12 months. Adults with cancer at intermediate-to-high risk of VTE, not planned for anticoagulation, are assigned to rosuvastatin or placebo to see if VTE and other cardiovascular events can be reduced. Eligibility includes recent cancer diagnosis or progression, KS 2-4 or mKS 2-5, ECOG 0-2, and life expectancy over 6 months. The trial excludes current statin or anticoagulant use and very low or extremely high VTE risk. Primary outcomes focus on VTE prevention and safety, with international multicenter involvement.

Why it matters

Who can join: the full rules

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's running

• City of Hope
  Irvine, California, United States Recruiting
• Yale University
  New Haven, Connecticut, United States Recruiting
• University of Miami
  Miami, Florida, United States Recruiting
• Beth Isreal Deaconess Medical Center
  Boston, Massachusetts, United States Recruiting
• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Recruiting

Study contacts

• Study coordinator: Elaine Zaharris
• Email: ezaharris@bwh.harvard.edu
• Phone: 857-282-0022

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.