Clinical trial · Interventional
Aspirin for Prevention of Venous Thromboembolism Among Ovarian Cancer Patients Receiving Neoadjuvant Chemotherapy
NCT04352439CI-TRIAL-00061027completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a pilot study to determine the safety and efficacy of low dose aspirin for the prevention of venous thromboembolism among women with advanced ovarian cancer receiving neoadjuvant chemotherapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Venous Thromboembolism | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aspirin | Drug | Aspirin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Aspirin
- description
- Patients with a Khorana risk score of 1 receive 81 mg aspirin daily while receiving neoadjuvant chemotherapy for ovarian cancer.
- interventionNames
- Drug: Aspirin
Primary outcomes (3)
- measure
- Number of Participants Experiencing a Venous Thromboembolism
- timeFrame
- Up to six months
- measure
- Number of Participants With at Least One Adverse Event
- timeFrame
- Up to six months
- description
- Adverse events will only include those that are determined to be related to the study drug.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Khorana score = 1 * Over age 18 * English-speaking female patients * Able to consent * Receiving neoadjuvant chemotherapy Cancer of primary ovarian, fallopian tube, mullerian, or peritoneal origin Exclusion Criteria: * Allergy or intolerance to study medication * Indication for a non-aspirin form of antiplatelet (i.e. cardiac stent) * Already on alternative form of anticoagulation * Active bleeding * High risk for active bleeding (i.e. recent intracranial bleed or gastrointestinal bleed, known brain metastases) * Thrombocytopenia (platelets \<50,000) * Unable to complete medication adherence diary * Unable to take oral medications
References
Publications (3)
- BACKGROUNDSalinaro JR, McQuillen K, Stemple M, Boccaccio R, Ehrisman J, Lorenzo AM, Havrilesky L, Secord AA, Galvan Turner V, Moore KN, Davidson B. Incidence of venous thromboembolism among patients receiving neoadjuvant chemotherapy for advanced epithelial ovarian cancer. Int J Gynecol Cancer. 2020 Apr;30(4):491-497. doi: 10.1136/ijgc-2019-000980. Epub 2020 Feb 12. PMID 32054646
- BACKGROUNDFaour M, Piuzzi NS, Brigati DP, Klika AK, Mont MA, Barsoum WK, Higuera CA. Low-Dose Aspirin Is Safe and Effective for Venous Thromboembolism Prophylaxis Following Total Knee Arthroplasty. J Arthroplasty. 2018 Jul;33(7S):S131-S135. doi: 10.1016/j.arth.2018.03.001. Epub 2018 Mar 8. PMID 29656974
- BACKGROUNDKey NS, Khorana AA, Kuderer NM, Bohlke K, Lee AYY, Arcelus JI, Wong SL, Balaban EP, Flowers CR, Francis CW, Gates LE, Kakkar AK, Levine MN, Liebman HA, Tempero MA, Lyman GH, Falanga A. Venous Thromboembolism Prophylaxis and Treatment in Patients With Cancer: ASCO Clinical Practice Guideline Update. J Clin Oncol. 2020 Feb 10;38(5):496-520. doi: 10.1200/JCO.19.01461. Epub 2019 Aug 5. PMID 31381464