Venous Thromboembolism (VTE) Clinical Trials

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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Brigham and Women's Hospital
ACTIVE_NOT_RECRUITING
Boston
Dana-Farber Cancer Institute
RECRUITING
Boston
Contact Information
Primary
Elaine Zaharris
ezaharris@bwh.harvard.edu
Time Frame
Start Date: 2026-06-11
Estimated Completion Date: 2032-03-31
Participants
Target number of participants: 4000
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Brigham and Women's Hospital
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), Dana-Farber/Brigham and Women's Cancer Center

This content was sourced from clinicaltrials.gov