Apixaban or Enoxaparin After Head and Neck Cancer Surgery

Q: Who can participate in NCT07189897?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT07189897?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

An Open-label Pilot Study to Evaluate Medication Satisfaction With Apixaban Versus Enoxaparin for Thrombosis Prevention After Head and Neck Cancer Surgery

Apixaban or Enoxaparin After Head and Neck Cancer Surgery (NCT07189897) is a Phase 4 interventional studying Venous Thromboembolism and Head and Neck Cancer, sponsored by Kiranya Arnold. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

The goal of this clinical trial is to learn if apixaban (a pill) is a safe and easier alternative to taking enoxaparin (a daily shot) to prevent blood clots after head and neck cancer surgery. It will also learn about side effects of both medicines. The main questions it aims to answer are: Can apixaban be used safely instead of enoxaparin to prevent blood clots after surgery? Do patients find apixaban easier or more satisfying to take than enoxaparin? How well do patients follow the treatment plan with each medicine? Researchers will compare 2 groups: One group will take apixaban (a pill taken twice a day) for 10 days after surgery. The other group will take enoxaparin (a shot given once a day) for 10 days after surgery. Participants will: Take either apixaban or enoxaparin starting 12-24 hours after surgery, for 10 days total Keep a medication diary and bring back unused medicine so the study team can check adherence Complete short surveys about satisfaction with their medicine Have an ultrasound of their legs to check for blood clots 11-14 days after surgery Return for follow-up visits about 40 days and 80 days after surgery for safety checks How long will participation last? About 4 months from surgery through the last follow-up visit.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 76 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Venous Thromboembolism subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: Participants must: - Provide signed and dated willing to sign a consent form. - Be willing and able to comply with study procedures and follow-up. - Be 18-89 years old (male or female). - Have a negative pregnancy test within 24 hours before surgery (if woman of childbearing potential). - Have biopsy-proven head and neck cancer, or a suspected cancer awaiting tissue diagnosis (can be confirmed by frozen section at surgery). - Be scheduled for major inpatient or outpatient oncologic head and neck surgery (defined as \>45 minutes operative time). - Be an appropriate surgical candidate (adequate performance status). Eligible diagnoses include (not limited to): - Squamous cell carcinoma of oral cavity, hypopharynx, larynx, nasal cavity - Malignancies from major salivary glands - Non-melanoma skin cancers (squamous cell, basal cell, Merkel cell carcinoma) - Unknown primary tumors of head and neck Who Should NOT Join This Trial: Participants cannot: - Lack a tissue diagnosis of head and neck cancer during the study period. - Have one of these conditions instead of eligible cancer: Benign disease; Primary thyroid cancer (lower VTE risk); Lymphoma (not primarily surgical); or Melanoma - Fail to undergo definitive head and neck oncologic surgery (e.g., only diagnostic biopsy). - Have surgery limited to tissue diagnosis only (e.g., direct laryngoscopy, excisional lymph node biopsy). - Be unable (patient or caregiver) to administer the study drug. - Have a positive pregnancy test on the day of surgery. - Have a known history of prior DVT or PE (since extended anticoagulation would be indicated). - Have hereditary or acquired bleeding/clotting disorders. - Have severe renal impairment (CrCl \<30 mL/min). - Have conditions that, in the investigator's judgment, make study participation unsafe or confound results. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: Participants must: * Provide signed and dated informed consent. * Be willing and able to comply with study procedures and follow-up. * Be 18-89 years old (male or female). * Have a negative pregnancy test within 24 hours before surgery (if woman of childbearing potential). * Have biopsy-proven head and neck cancer, or a suspected cancer awaiting tissue diagnosis (can be confirmed by frozen section at surgery). * Be scheduled for major inpatient or outpatient oncologic head and neck surgery (defined as \>45 minutes operative time). * Be an appropriate surgical candidate (adequate performance status). Eligible diagnoses include (not limited to): * Squamous cell carcinoma of oral cavity, hypopharynx, larynx, nasal cavity * Malignancies from major salivary glands * Non-melanoma skin cancers (squamous cell, basal cell, Merkel cell carcinoma) * Unknown primary tumors of head and neck Exclusion Criteria: Participants cannot: * Lack a tissue diagnosis of head and neck cancer during the study period. * Have one of these conditions instead of eligible cancer: Benign disease; Primary thyroid cancer (lower VTE risk); Lymphoma (not primarily surgical); or Melanoma * Fail to undergo definitive head and neck oncologic surgery (e.g., only diagnostic biopsy). * Have surgery limited to tissue diagnosis only (e.g., direct laryngoscopy, excisional lymph node biopsy). * Be unable (patient or caregiver) to administer the study drug. * Have a positive pregnancy test on the day of surgery. * Have a known history of prior DVT or PE (since extended anticoagulation would be indicated). * Have hereditary or acquired bleeding/clotting disorders. * Have severe renal impairment (CrCl \<30 mL/min). * Have conditions that, in the investigator's judgment, make study participation unsafe or confound results.

Treatments Being Tested

DRUG

Enoxaparin

For DVT prophylaxis

DRUG

Apixaban

For DVT prophylaxis

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

SUNY Upstate

Syracuse, New York, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07189897), the sponsor (Kiranya Arnold), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07189897 clinical trial studying?

Who can participate in NCT07189897?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07189897?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07189897. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07189897. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.