Oral Anticoagulant Apixaban for Treatment of Venous Thromboembolism (VTE)

• ClinicalTrials.gov Identifier: NCT04041843
• Recruitment Status: Recruiting
• First Posted: August 1, 2019
• Last Update Posted: September 9, 2020
• Sponsor: New York Medical College
• Information provided by (Responsible Party): New York Medical College

Study Description

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

Study Design

• 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, 2021
• Estimated Study Completion Date: May 31, 2022

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

Contact: Erin Morris, RN; (714) 964-5359; erin_morris@nymc.edu

Contact: Oya Tugal, MD; (914) 594-2134; oya_tugal@nymc.edu

Locations

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

• Principal Investigator: Oya Tugal, MD; New York Medical College

More Information

• Responsible Party: New York Medical College
• ClinicalTrials.gov Identifier: NCT04041843
• Other Study ID Numbers: NYMC 191
• First Posted: August 1, 2019
• Last Update Posted: September 9, 2020
• Last Verified: September 2020

• 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:

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