Pilot Study of Rosuvastatin and Enoxaparin Thromboprophylaxis Following Ovarian Cancer Surgery (O-STAT Study)
NCT03532139 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2025-01-23
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
Conditions
Interventions
- DRUG
-
Enoxaparin
Enoxaparin is used for prevention of blood clots following abdominal or orthopedic surgery and in medical patients with restricted mobility during acute illness
- DRUG
-
Enoxaparin + Rosuvastatin
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
- OTHER
-
Thromboprophylaxis
standard of care therapy
Sponsors & Collaborators
-
National Institutes of Health (NIH)
collaborator NIH -
National Heart, Lung, and Blood Institute (NHLBI)
collaborator NIH -
Beth Israel Deaconess Medical Center
lead OTHER
Principal Investigators
-
Rushad Patell, MD · Beth Israel Deaconess Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-07-25
- Primary Completion
- 2023-12-31
- Completion
- 2024-05-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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