Statins to Prevent Cancer Associated Blood Clots

NCT07303816 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: 25-789UG3HL176627
• Study Type: interventional
• Target: 4,000
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Venous Thromboembolism; Cancer; Cardiovascular Events

Keywords

statin; pulmonary embolism; rosuvastatin; cancer; venous thromboembolism; prophylactic anticoagulation

Outcome Measures

Primary Outcomes (1)

• Assess whether Rosuvastatin versus placebo over a period of one year reduces the risk of incident (first event) VTE among patients with cancer

  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 Outcomes (1)

• 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

  12 months

Other Outcomes (3)

• Safety Endpoint: Identify transaminitis > 5 x ULN on two consecutive tests at least one week apart

  12 months

• Safety Endpoint: Identify CK > 5 x ULN on two consecutive tests at least one week apart

  12 months

• Safety Endpoint: Identify clinical myositis, rhabdomyolysis, major bleeding and clinically relevant non-major bleeding

  12 months

Study Arms (2)

Active Rosuvastatin Arm

EXPERIMENTAL

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

Placebo Arm

PLACEBO COMPARATOR

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

Interventions

Rosuvastatin DRUG

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.

Active Rosuvastatin Arm

Placebo Drug DRUG

The placebo pills are pills with no medicine in them.

Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

ACTIVE NOT RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Venous Thromboembolism; Neoplasms; Pulmonary Embolism

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Elaine Zaharris

CONTACT

ezaharris@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: December 26, 2025
• Study Start: June 11, 2026
• Primary Completion (Estimated): March 31, 2031
• Study Completion (Estimated): March 31, 2032
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

US (2)