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Brief Title: Pilot Study of Rosuvastatin and Enoxaparin Thromboprophylaxis Following Ovarian Cancer Surgery (O-STAT Study)
Official Title: Pilot Study of Rosuvastatin and Enoxaparin Thromboprophylaxis Following Ovarian Cancer Surgery (O-STAT Study)
Study ID: NCT03532139
Brief Summary: 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
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Massachusetts General Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Name: Rushad Patell, MD
Affiliation: Beth Israel Deaconess Medical Center
Role: PRINCIPAL_INVESTIGATOR