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Ovarian CancerPhase 2NCT03532139

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

A Phase 2 study testing Enoxaparin, Enoxaparin + Rosuvastatin and Thromboprophylaxis in people with Ovarian Cancer, run by Beth Israel Deaconess Medical Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Enoxaparin, Enoxaparin + Rosuvastatin and Thromboprophylaxis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
2 sitesUnited States
Study dates
25 Jul 2018to 31 May 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02214

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

Other trials in United States

About this study

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
Read the 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
Being tested
Enoxaparin, Enoxaparin + Rosuvastatin, Thromboprophylaxis
Keywords
Ovarian Cancer
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EnoxaparinDrug

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

  • Enoxaparin + RosuvastatinDrug

    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

  • ThromboprophylaxisOther

    standard of care therapy

Study groups in NCT03532139
Study groupRoleWhat they receive
EnoxaparinExperimental-Enoxaparin is administered subcutaneous daily
Receives: Drug: Enoxaparin
Enoxaparin + RosuvastatinExperimental* Enoxaparin is administered subcutaneous daily. * Rosuvastatin is administered daily orally starting on day 15
Receives: Drug: Enoxaparin; Drug: Enoxaparin + Rosuvastatin
ThromboprophylaxisExperimental-Thromboprophylaxis is administered per clinician discretion
Receives: Other: Thromboprophylaxis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Concentration of Tissue Factor Bearing Microparticles

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

    Measured: 30 days

Secondary outcomes (3)

  1. VTE Rate

    Estimate of the number of participants who experienced VTE following ovarian surgery in each study arm

    Measured: 60 days

  2. D-dimer Concentration

    Comparison of D-dimer values across study arms

    Measured: 60 days

  3. CRP Concentration

    Compare CRP between study arms

    Measured: 60 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2018
  2. Study start25 Jul 2018
  3. Primary completion31 Dec 2023
  4. Study completion31 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03532139
Sponsor's protocol ID
18-067
Other IDs
1R34HL135226-01
Status last verified
Jan 2025
First submitted
27 Apr 2018
Last updated
9 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Enoxaparin, Enoxaparin + Rosuvastatin and Thromboprophylaxis in people with Ovarian Cancer, run by Beth Israel Deaconess Medical Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concentration of Tissue Factor Bearing Microparticles (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03532139.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

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