Pilot Study of Rosuvastatin and Enoxaparin Thromboprophylaxis Following Ovarian Cancer Surgery (O-STAT Study)

  • STATUS
    Recruiting
  • End date
    May 31, 2024
  • participants needed
    40
  • sponsor
    Beth Israel Deaconess Medical Center
Updated on 12 December 2021
direct bilirubin
peritoneal cancer
primary peritoneal carcinoma
cancer of the ovary
surgery for ovarian cancer

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

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.

Details
Condition Ovarian disorder, Ovarian Function, Ovarian Cancer, Ovarian Cancer, Recurrent Ovarian Cancer, Ovarian Function, Recurrent Ovarian Cancer, ovarian carcinomas, cancer, ovarian, cancer ovarian, cancer of the ovary, ovarian tumors
Treatment Enoxaparin, Enoxaparin + Rosuvastatin, Thromboprophylaxis, Thromboprophylaxis
Clinical Study IdentifierNCT03532139
SponsorBeth Israel Deaconess Medical Center
Last Modified on12 December 2021

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