Statins to Prevent Cancer Associated Blood Clots
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Rosuvastatin
- Placebo Drug
Treatment groups
4,000 Participants
are divided into 2 treatment groupsSponsors and collaborators
Brigham and Women's Hospital
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Dana-Farber/Brigham and Women's Cancer Center
Collaborator
Source ClinicalTrials.gov