This research study is studying a combination of two drug interventions called rosuvastatin and enoxaparin as a possible preventative measure against developing venous blood clots (such deep vein thrombosis or pulmonary embolism). . The drugs involved in this study are: * Rosuvastatin, also known as Crestor * Enoxaparin
This is a randomized pilot trial to estimate the effect of rosuvastatin on levels of tissue factor bearing microparticles (TFMP) in patients undergoing surgery for presumed ovarian cancer (including primary peritoneal and fallopian tube carcinoma). Women will either be randomized to enoxaparin subcutaneously once daily (Arm A) or enoxaparin in combination with rosuvastatin (Arm B). Arm C will receive thromboprophylaxis according to standard of care and not be randomized. Levels of circulating TFMP will be assessed in all patients on Day 1 and following surgery (days 15, 30 and day 60). A bilateral lower extremity ultrasound will be performed on days 30 and 60 for all participants to estimate the rate of VTE in the 3 arms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
24
Enoxaparin is used for prevention of blood clots following abdominal or orthopedic surgery and in medical patients with restricted mobility during acute illness
Rosuvastatin is an anti-cholesterol medication that is FDA (the U.S. Food and Drug Administration) approved to lower cholesterol and reduce the risk of arterial blood clots. There is evidence that rosuvastatin can lower the risk of venous blood clots in healthy individuals Enoxaparin is used for prevention of blood clots following abdominal or orthopedic surgery and in medical patients with restricted mobility during acute illness
standard of care therapy
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Comparison of differences in circulating tissue factor bearing microparticles between study arms
Concentration of tissue factor bearing microparticles
Time frame: 60 days
Point estimate of the rates of VTE following ovarian surgery in each study arm
VTE rate
Time frame: 60 days
Comparison of D-dimer values across study arms
D-dimer concentration
Time frame: 60 days
Compare the rates of VTE between study arms
VTE rate in arm A and B
Time frame: 60 days
Compare CRP between study arms
CRP concentration
Time frame: 60 days
Compare concentrations of TFMP, D-dimer, CRP at study timepoints.
Baseline vs day 60 comparison for TFMP, D-dimer, CRP on each arm
Time frame: 60 days
Assess incidence of major hemorrhage and clinically relevant bleeding as defined by the International Society of Thrombosis and Haemostasis
Major and clinically relevant non-major bleeding rates
Time frame: 60 days
Estimate the overall rate of any VTE
Overall VTE rates
Time frame: 60 days
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