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

NCT ID: NCT03532139

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-25
• Study Completion Date: 2024-05-31

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.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Enoxaparin

-Enoxaparin is administered subcutaneous daily

Group Type: EXPERIMENTAL

Enoxaparin

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

Enoxaparin

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Thromboprophylaxis

-Thromboprophylaxis is administered per clinician discretion

Group Type: EXPERIMENTAL

Thromboprophylaxis

Intervention Type: OTHER

standard of care therapy

Interventions

Enoxaparin

Enoxaparin is used for prevention of blood clots following abdominal or orthopedic surgery and in medical patients with restricted mobility during acute illness

Intervention Type: 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

Intervention Type: DRUG

Thromboprophylaxis

standard of care therapy

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Histologic diagnosis of ovarian, fallopian or primary peritoneal cancer (excluding borderline histologies). Preliminary pathology results based on frozen section findings are acceptable.
• The interval between pelvic or abdominal surgery and first dose of study treatment must be no more than 10 days.
• Age ≥ 18 years.
• ECOG performance status ≤2 (see Appendix A)
• Life expectancy of greater than 6 months
• Participants must have normal organ and marrow function as defined below:

• Platelets ≥ 100,000/mcL
• Total Bilirubin <1.5 mg/dL (or direct bilirubin <1.0 mg/dL)
• AST(SGOT) ≤ 1.5 × institutional upper limit of normal
• ALT(SGPT) ≤ 1.5 × institutional upper limit of normal
• Creatinine < 1.5 mg/dL OR
• Estimated creatinine clearance ≥60 mL/min/1.73 m2
• The effects of rosuvastatin on the developing human fetus are unknown. For this reason and because statins used in this trial are thought to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• Participants who are receiving any other investigational agents.
• Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and increased risk of intracranial hemorrhage
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to enoxaparin or atorvastatin
• Active bleeding or high risk of bleeding (e.g. known acute gastrointestinal ulcer)
• History of heparin-induced thrombocytopenia.
• Any history of significant hemorrhage (requiring hospitalization or transfusion) outside of a surgical setting within the last year.
• Presence of coagulopathy defined as:

• PT > 1.3 x upper limit of normal
• PTT > 1.3 x upper limit of normal
• Uncontrolled hypothyroidism (defined as TSH below lower limit of normal). Qualifying TSH may be within 60 days prior to enrollment. If screening TSH is low, patients are eligible if free T4 is within normal limits.
• Familial bleeding diathesis
• Known diagnosis of disseminated intravascular coagulation
• Currently taking statin (i.e. rosuvastatin, atorvastatin, simvastatin) or fibrates
• Currently receiving anticoagulant therapy
• Current use of aspirin (>81 mg daily), Clopidogrel (Plavix), cilostazol (Pletal), aspirin-dipyridamole (Aggrenox).
• Known Asian descent (including Filipino, Chinese, Japanese, Korean, Vietnamese or Asian-Indian origin) due to altered metabolism of statins.
• Concomitant use of the following drugs: cyclosporine, fibrates, niacin, gemfibrozil, ketoconazole, spironolactone, cimetidine, warfarin, erythromycin, or protease inhibitors
• Known recent history of heavy alcohol use
• History of rhabdomyolysis while on statin therapy.
• Known active Hepatitis C or active Hepatitis B infection.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant women are excluded from this study due to the potential for teratogenic effects on the human fetus. Because there is an unknown but potential risk of adverse events in nursing infants secondary to the treatment of the mother with rosuvastatin, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Rushad Patell

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rushad Patell, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

1R34HL135226-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

18-067

Identifier Type: -

Identifier Source: org_study_id