Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
4000 participants
INTERVENTIONAL
2026-04-01
2032-03-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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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.
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 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.
Placebo Drug
The placebo pills are pills with no medicine in them.
Interventions
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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 Drug
The placebo pills are pills with no medicine in them.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Dana-Farber/Brigham and Women's Cancer Center
OTHER
Brigham and Women's Hospital
OTHER
Responsible Party
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Paul Ridker
Principal Investigator
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Jean Connors, MD
Role: primary
Christine Cronin, MHA
Role: backup
Other Identifiers
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25-789
Identifier Type: -
Identifier Source: org_study_id