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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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Start Date
July 25, 2018
Primary Completion Date
December 31, 2023
Completion Date
May 31, 2024
Last Updated
January 23, 2025
24
ACTUAL participants
Enoxaparin
DRUG
Enoxaparin + Rosuvastatin
DRUG
Thromboprophylaxis
OTHER
Lead Sponsor
Beth Israel Deaconess Medical Center
Collaborators
NCT04550494
NCT05039801
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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