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Aspirin for Prevention of Venous Thromboembolism Among Ovarian Cancer Patients Receiving Neoadjuvant Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04352439
Recruitment Status : Recruiting
First Posted : April 20, 2020
Last Update Posted : August 25, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:

This is a pilot study to determine the safety and efficacy of low dose aspirin for the prevention of venous thromboembolic events among women with advanced ovarian cancer receiving neoadjuvant chemotherapy.

Subjects who are receiving neoadjuvant chemotherapy for advanced epithelial ovarian cancer will be recruited from the Duke Gynecology Oncology clinic at Duke Cancer Institute. After discussion of the risks and benefits, written informed consent will be obtained for initiation of prophylactic, daily low dose aspirin (81 mg) therapy. Subjects will receive aspirin tablets in medication vials obtained from the Duke pharmacy supply and will be instructed to take one tablet daily until the day of their interval debulking surgery. Subjects will be followed throughout the primary treatment course and monitored for the occurrence of venous thromboembolic events. Subjects will also be instructed to complete medication adherence diaries that will be reviewed by the research team. The investigators hypothesize that daily low dose aspirin will reduce the incidence of venous thromboembolic events during neoadjuvant chemotherapy when compared to a historical control.

The incidence of venous thromboembolism among the study cohort will be calculated with an estimated 95% exact binomial confidence interval. A drop of greater than 20% (from 8% estimated in the historical control to 6.4%) in rate of venous thromboembolism would be considered clinically meaningful. The investigators will also monitor for adverse drug events related to low dose aspirin use, including major or minor bleeding events, clinically significant thrombocytopenia (resulting in treatment delay), and gastrointestinal complications. Of note, low dose aspirin for venous thromboembolism prevention is already considered an acceptable option for standard of care for patients with multiple myeloma receiving antiangiogenesis agents with chemotherapy and/or dexamethasone as well as for postoperative prophylaxis following some orthopedic procedures. The investigators therefore feel the potential benefit outweighs any clinically significant risks.


Condition or disease Intervention/treatment Phase
Venous Thromboembolism Ovarian Cancer Drug: Aspirin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Aspirin for Prevention of Venous Thromboembolism Among Ovarian Cancer Patients Receiving Neoadjuvant Chemotherapy
Actual Study Start Date : August 8, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: Aspirin
Patients receive 81 mg aspirin daily while receiving neoadjuvant chemotherapy for ovarian cancer.
Drug: Aspirin
81 mg aspirin daily




Primary Outcome Measures :
  1. Rate of venous thromboembolism [ Time Frame: Up to six months ]
    Percentage of patients experiencing a venous thromboembolism.

  2. Number of participants with at least one adverse event [ Time Frame: Up to six months ]
    Adverse events will only include those that are determined to be related to the study drug.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Over age 18
  • English-speaking female patients
  • Able to consent
  • Recruited from the Duke Gynecology Oncology clinic
  • Receiving neoadjuvant chemotherapy for advanced epithelial ovarian cancer

Exclusion Criteria:

  • Allergy or intolerance to study medication
  • Indication for a specific form of antiplatelet (i.e. cardiac stent)
  • Already on anticoagulation
  • Active bleeding
  • High risk for active bleeding (i.e. recent intracranial bleed or gastrointestinal bleed)
  • Thrombocytopenia
  • Unable to complete medication adherence diary
  • Unable to take oral medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04352439


Contacts
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Contact: Taylor Hayes 919-684-9065 taylor.hayes@duke.edu
Contact: Bonnie Thiele 919-668-7478 bonnie.thiele@duke.edu

Locations
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United States, North Carolina
Duke University Hospital Recruiting
Durham, North Carolina, United States, 27710
Contact: Taylor Hayes         
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Brittany Davidson, MD Duke University
Publications:
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04352439    
Other Study ID Numbers: Pro00105081
First Posted: April 20, 2020    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Thromboembolism
Venous Thromboembolism
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents