NCT07303816

Statins to Prevent Cancer Associated Blood Clots

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 4,000 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Venous Thromboembolism
• Cancer
• Cardiovascular Events

Interventions

Type	Name	Description
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.
DRUG	Placebo Drug	The placebo pills are pills with no medicine in them.

Timeline

• Start date: 2026-04-01
• Primary completion: 2031-03-31
• Completion: 2032-03-31
• First posted: 2025-12-26
• Last updated: 2025-12-26

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study