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Oral Anticoagulant Apixaban for Treatment of Venous Thromboembolism (VTE)

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: NCT04041843
Recruitment Status : Recruiting
First Posted : August 1, 2019
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
New York Medical College

Brief Summary:
Patients who have developed a venous thrombosis will receive apixaban to treat and prevent a secondary thromboembolism.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Drug: Apixaban Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of an Oral Anticoagulant "Apixaban" for theTreatment of Venous Thromboembolism in Children and Adolescents
Actual Study Start Date : June 2, 2017
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
Drug Information available for: Apixaban

Arm Intervention/treatment
Experimental: Abixaban
Apixaban 10 mg twice daily p.o. for seven days followed by 5 mg twice daily p.o. for children and adolescents weighting ≥40 kg who have been diagnosed with a thrombosis.
Drug: Apixaban
Apixaban 10 mg twice daily p.o. for seven days followed by 5 mg twice daily p.o. for children and adolescents weighting ≥40 kg
Other Name: Eliquis




Primary Outcome Measures :
  1. venous thromboembolism (VTE) formation [ Time Frame: 7-90 days ]
    No new VTE


Secondary Outcome Measures :
  1. Doppler ultrasound vein imaging [ Time Frame: day 8-15 ]
    Change in VTE on Doppler ultrasound



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:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children and adolescents with a newly diagnosed primary VTE.
  • Treatment with apixaban has to begin within 72 hours of the diagnosis of VTE.
  • Patients who have received heparin at the beginning of their diagnosis and are willing to switch to apixaban, are allowed to do so within 72 hours of their treatment. Patients who are switched to apixaban are not allowed to receive any other systemic anticoagulant therapy.
  • VTE confirmed by diagnostic imaging.
  • Children with body weight of ≥ 40 kg and are able to tolerate medication by mouth or administered via an NG or GT tube.
  • Adequate liver function: AST and/or ALT <5 times ULN, and/or Direct bilirubin <2 times ULN
  • Platelet count of at least ≥ 30,000/ul.
  • Adequate renal function: >30% of GFR for age
  • Female subjects of childbearing potential must not be nursing or pregnant with negative urine pregnancy test within 72 hours prior to dosing with study medication.
  • Signed written informed consent

Exclusion Criteria:

  • Current or recent (within 3 months) apixaban administration.
  • Patient is unable to tolerate medications by oral route or by n/g administration, peptic ulcer disease, intestinal obstruction, toxic megacolon, typhlitis, or short gut syndrome.
  • History of primary bleeding disorder and first degree family history of bleeding disorder.
  • Active bleeding or high risk of bleeding at the time of study entry.
  • History of significant head injury and/or any history of intracranial hemorrhage.
  • Conditions predispose to intracranial bleed; e.g. brain tumor, brain metastasis.
  • Uncontrolled Grade 3 or 4 severe hypertension.
  • History of allergy to apixaban or factor Xa inhibitors.

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): NCT04041843


Contacts
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Contact: Erin Morris, RN (714) 964-5359 erin_morris@nymc.edu
Contact: Oya Tugal, MD (914) 594-2134 oya_tugal@nymc.edu

Locations
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United States, New York
New York Medical College Recruiting
Valhalla, New York, United States, 10595
Contact: Harshini Mahanti, BBTech, MSCR    360-362-9008    harshini_mahanti@nymc.edu   
Contact: Neida Otero, CRA    (914) 594-2146    neida.Otero@wmchealth.org   
Sponsors and Collaborators
New York Medical College
Investigators
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Principal Investigator: Oya Tugal, MD New York Medical College
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Responsible Party: New York Medical College
ClinicalTrials.gov Identifier: NCT04041843    
Other Study ID Numbers: NYMC 191
First Posted: August 1, 2019    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020

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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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Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Apixaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants