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

NCT03532139 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: 18-0671R34HL135226-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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

Conditions

Ovarian Cancer

Keywords

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Comparison of differences in circulating tissue factor bearing microparticles between study arms

  Concentration of tissue factor bearing microparticles

  60 days

Secondary Outcomes (7)

• Point estimate of the rates of VTE following ovarian surgery in each study arm

  60 days

• Comparison of D-dimer values across study arms

  60 days

• Compare the rates of VTE between study arms

  60 days

• Compare CRP between study arms

  60 days

• Compare concentrations of TFMP, D-dimer, CRP at study timepoints.

  60 days

Study Arms (3)

Enoxaparin

EXPERIMENTAL

-Enoxaparin is administered subcutaneous daily

Drug: Enoxaparin

Enoxaparin + Rosuvastatin

EXPERIMENTAL

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

Drug: Enoxaparin; Drug: Enoxaparin + Rosuvastatin

Thromboprophylaxis

EXPERIMENTAL

-Thromboprophylaxis is administered per clinician discretion

Other: Thromboprophylaxis

Interventions

Enoxaparin 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; Enoxaparin + Rosuvastatin

Enoxaparin + Rosuvastatin 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

Enoxaparin + Rosuvastatin

Thromboprophylaxis OTHER

standard of care therapy

Thromboprophylaxis

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02214, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Enoxaparin; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Rushad Patell, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: May 22, 2018
• Study Start: July 25, 2018
• Primary Completion: December 31, 2023
• Study Completion: May 31, 2024
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)