Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Lipid Regulating Agents

All Drugs and Chemicals

Fibrinolytic Agents

Anticoagulants

Bone Density Conservation Agents

Rosuvastatin Calcium

Enoxaparin

Enoxaparin sodium

Calcium

Calcium, Dietary

Anticholesteremic Agents

Hypolipidemic Agents

Antimetabolites

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Enzyme Inhibitors

-Enoxaparin is administered subcutaneous daily

* Enoxaparin is administered subcutaneous daily.
* Rosuvastatin is administered daily orally starting on day 15

-Thromboprophylaxis is administered per clinician discretion

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

Enoxaparin + Rosuvastatin

Thromboprophylaxis

Rushad Patell, MD

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.

Patients will be randomized to Arm Enoxaparin and Arm Enoxaparin + Rosuvastatin, and those requesting no randomization willl be directly assigned to Arm Standard-of-care Thromboprophylaxis

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

Concentration of tissue factor bearing microparticles

Baseline vs day 60 comparison for TFMP, D-dimer, CRP on each arm

Major and clinically relevant non-major bleeding rates

National Institutes of Health (NIH)

National Heart, Lung, and Blood Institute (NHLBI)

Beth Israel Deaconess Medical Center

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pilot Study of Rosuvastatin and Enoxaparin Thromboprophylaxis Following Ovarian Cancer Surgery (O-STAT Study)	NCT03532139	Ovarian Cancer	Enoxaparin Enoxaparin + Ro... Thromboprophyla...	18 Years -	Beth Israel Deaconess Medical Center
Pilot Study of Rosuvastatin and Enoxaparin Thromboprophylaxis Following Ovarian Cancer Surgery (O-STAT Study)	NCT03532139	Ovarian Cancer	Enoxaparin Enoxaparin + Ro... Thromboprophyla...	18 Years -	Beth Israel Deaconess Medical Center
Pilot Study of Rosuvastatin and Enoxaparin Thromboprophylaxis Following Ovarian Cancer Surgery (O-STAT Study)	NCT03532139	Ovarian Cancer	Enoxaparin Enoxaparin + Ro... Thromboprophyla...	18 Years -	Beth Israel Deaconess Medical Center

Spots Global Cancer Trial Database for enoxaparin + rosuvastatin