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Anticoagulant

Enoxaparin + Rosuvastatin for Blood Clot Prevention After Ovarian Cancer Surgery

Phase 2

Waitlist Available

Led By Jeffrey Zwicker, MD

Research Sponsored by Beth Israel Deaconess Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years.

Histologic diagnosis of ovarian, fallopian or primary peritoneal cancer (excluding borderline histologies). Preliminary pathology results based on frozen section findings are acceptable.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 days

Awards & highlights

Study Summary

This trial is testing whether or not the combination of these two drugs can help to prevent venous blood clots, which can lead to conditions such as deep vein thrombosis or pulmonary embolism.

Who is the study for?

This trial is for adults over 18 with ovarian, fallopian tube, or primary peritoneal cancer who've had surgery within the last 10 days. They need normal organ function and a life expectancy over 6 months. Participants must not be pregnant, breastfeeding, have certain blood disorders or be on specific medications like high-dose aspirin or other anticoagulants.Check my eligibility

What is being tested?

The study tests rosuvastatin (Crestor) and enoxaparin as preventive treatments against venous blood clots after ovarian cancer surgery. It's a pilot study to see if this drug combo can reduce clot risks without significant side effects.See study design

What are the potential side effects?

Possible side effects include bleeding complications, liver enzyme changes leading to potential liver damage, muscle pain or weakness which could indicate muscle damage (rhabdomyolysis), and allergic reactions to the drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with ovarian, fallopian, or primary peritoneal cancer.

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My kidney function is normal based on creatinine levels or clearance.

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I can take care of myself but might not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Assess incidence of major hemorrhage and clinically relevant bleeding as defined by the International Society of Thrombosis and Haemostasis

Compare CRP between study arms

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

+4 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: ThromboprophylaxisExperimental Treatment1 Intervention

-Thromboprophylaxis is administered per clinician discretion

Group II: Enoxaparin + RosuvastatinExperimental Treatment2 Interventions

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

Group III: EnoxaparinExperimental Treatment1 Intervention

-Enoxaparin is administered subcutaneous daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enoxaparin

2017

Completed Phase 4

~32400

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor

837 Previous Clinical Trials

13,010,248 Total Patients Enrolled

13 Trials studying Ovarian Cancer

502 Patients Enrolled for Ovarian Cancer

National Institutes of Health (NIH)NIH

2,698 Previous Clinical Trials

7,492,475 Total Patients Enrolled

13 Trials studying Ovarian Cancer

949 Patients Enrolled for Ovarian Cancer

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,836 Previous Clinical Trials

47,850,833 Total Patients Enrolled

Media Library

Ovarian Cancer Research Study Groups: Enoxaparin + Rosuvastatin, Enoxaparin, Thromboprophylaxis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the scientific literature feature any investigations combining Enoxaparin and Rosuvastatin?

"Currently, 19 Phase 3 trials are exploring the efficacy of Enoxaparin + Rosuvastatin with 59 total clinical studies in progress. While Bethesda Maryland hosts most research on this combination therapy, 692 sites across the world have been identified to conduct these experiments."

Answered by AI

How risky is the combination of Enoxaparin and Rosuvastatin for patient health?

"Our team of experts at Power rated Enoxaparin and Rosuvastatin as a 2 on the safety scale due to its Phase 2 status, which implies that there is some data supporting protection but not efficacy."

Answered by AI

What is the current participant count for this research endeavor?

"Presently, this medical trial is not enrolling participants. It was initially posted on July 25th 2018 and received its most recent update on October 13th 2022. Alternately, 677 studies are actively seeking patients with a carcinoma diagnosis while 59 trials for Enoxaparin + Rosuvastatin have openings available."

Answered by AI

Are there still spots available for this research endeavor?

"This research study is no longer accepting applicants. The trial was initially posted on July 25th 2018, with the most recent modification made on October 13th 2022. If you are looking for additional studies, 677 clinical trials involving carcinoma and ovarian epithelial are presently recruiting candidates while 59 Enoxaparin + Rosuvastatin related studies demand participants as well."

Answered by AI

Under what conditions is the combination of Enoxaparin and Rosuvastatin typically employed?

"Enoxaparin + Rosuvastatin is traditionally employed to address acute chest syndrome, though it can also prove useful in managing hypertriglyceridemias and cardiovascular disease (CVD) outside of a hospital setting."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Rushad Patell 2018. "Pilot Study of Rosuvastatin and Enoxaparin Thromboprophylaxis Following Ovarian Cancer Surgery (O-STAT Study)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03532139.

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