Statins to Prevent Cancer Associated Blood Clots

Study summary

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.

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Key things to know

Main goalPrevention

This describes the study’s primary purpose.

What is being studiedRosuvastatin and Placebo Drug

The study team can explain what participation involves.

Who it may be forRecurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 16, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 4

Interventional

Where is it offered?9 U.S. locations

Locations may change over time.

Who runs it?Brigham and Women's Hospital

Study sponsor

Study overview

What this study is about

Purpose: Prevention
Study type: Interventional
Phase: Phase 4
Sponsor: Brigham and Women's Hospital
Interventions being studied: Drug: Rosuvastatin; Drug: Placebo Drug

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Disease setting

Recurrent or relapsed→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

City of HopeIrvine, California
Yale UniversityNew Haven, Connecticut
University of MiamiMiami, Florida
Beth Isreal Deaconess Medical CenterBoston, Massachusetts
Brigham and Women's HospitalBoston, Massachusetts
Dana-Farber Cancer InstituteBoston, Massachusetts
Mayo ClinicRochester, Minnesota
Cleveland Clinic FoundationCleveland, Ohio
The University of Texas MD Anderson Cancer CenterHouston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 16, 2026. Always confirm current availability with the study team.

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