Statins to Prevent Cancer Associated Blood Clots (STAT-CAT)

September 15, 2026 updated by: Paul Ridker, Brigham and Women's Hospital

STAT-CAT: Statin Therapy to Prevent Cancer Associated Venous Thromboembolism

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This trial is a randomized, double-blind, placebo-controlled trial of rosuvastatin 20 mg po daily in the prevention of venous thromboembolism (VTE) and other cardiovascular events among individuals recently diagnosed with cancer who are not scheduled to receive prophylactic anticoagulation and are at risk for VTE as defined by a Khorana Score (KS) 2 to 4 or a modified Khorana Score (mKS) 2 to 5.

Study Type

Interventional

Enrollment (Estimated)

4000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Irvine, California, United States, 90101
        • Recruiting
        • City of Hope
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Amanda Hutchinson, MD
        • Sub-Investigator:
          • Daniel Ng, MD
    • Connecticut
      • New Haven, Connecticut, United States, 06511
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Contact:
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Ann Hubben, MD
        • Sub-Investigator:
          • Shayna Sarosiek, MD
        • Sub-Investigator:
          • Benjamin Schlechter, MD
        • Sub-Investigator:
          • Robert Stern, MD
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Isreal Deaconess Medical Center
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Kenneth Bauer, MD
      • Boston, Massachusetts, United States, 02215
        • Active, not recruiting
        • Brigham and Women's Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Not yet recruiting
        • Cleveland Clinic Foundation
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Mehrie Patel, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas MD Anderson Cancer Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Rosuvastatin Arm
Patients in the Active Rosuvastatin Arm will take 20mg rosuvastatin daily for a period of 12 months. Note: This is a double-blinded study so patients and providers will not know what arm they are in.
Drug: Rosuvastatin
Rosuvastatin is a statin drug that helps reduce cholesterol and can help reduce risks of blood clots. In this study, patients will take 20mg of Rosuvastatin (or placebo) for to 12 months.
Placebo Comparator: Placebo Arm
Patients in the Placebo Arm will take 20mg placebo daily for a period of 12 months. Note: This is a double-blinded study so patients and providers will not know what arm they are in.
Drug: Placebo Drug
The placebo pills are pills with no medicine in them.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess whether Rosuvastatin versus placebo over a period of one year reduces the risk of incident (first event) VTE among patients with cancer
Time Frame: 12 months
The primary endpoint of the trial is the time from taking the first dose of study medication after randomization (modified intention to treat, mITT) to the first confirmed occurrence of the primary VTE endpoint. The primary analysis will use a likelihood ratio test based on a proportional hazards model stratified by eligibility criteria (eligible due to KS criteria alone or eligible due to mKS criteria), and enrollng center to test the null hypothesis of no association between assignment to active statin treatment and the rate of the primary endpoint. All analyses will classify patients according to their randomized treatment assignment, i.e. according to the intention to treat principle, and will base evaluation of statistical significance on a two-sided test with level 0.05. The estimated relative hazard in the statin compared to the placebo group with accompanying 95% confidence interval will quantify the treatment effect45. If this relative hazard is less than 1, then 100*(1-esti
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess whether Rosuvastatin versus placebo over a period of one year reduces the cumulative incidence of a composite of venous and arterial thrombosis events among patients with cancer
Time Frame: 12 months
12 months

Other Outcome Measures

Outcome Measure
Time Frame
Safety Endpoint: Identify transaminitis > 5 x ULN on two consecutive tests at least one week apart
Time Frame: 12 months
12 months
Safety Endpoint: Identify CK > 5 x ULN on two consecutive tests at least one week apart
Time Frame: 12 months
12 months
Safety Endpoint: Identify clinical myositis, rhabdomyolysis, major bleeding and clinically relevant non-major bleeding
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
Dana-Farber/Brigham and Women's Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2026

Primary Completion (Estimated)

March 31, 2031

Study Completion (Estimated)

March 31, 2032

Study Registration Dates

First Submitted

December 23, 2025

First Submitted That Met QC Criteria

December 23, 2025

First Posted (Actual)

December 26, 2025

Study Record Updates

Last Update Posted (Actual)

September 16, 2026

Last Update Submitted That Met QC Criteria

September 15, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-789
  • UG3HL176627 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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