Oral Anticoagulant Apixaban for Treatment of Venous Thromboembolism

Venous Thromboembolism Clinical Trial

— VTE  

Official title:

A Pilot Study of an Oral Anticoagulant "Apixaban" for theTreatment of Venous Thromboembolism in Children and Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04041843
• Other study ID #: NYMC 191
• Status: Completed
• Phase: Phase 2
• Start date: June 2, 2017
• Est. completion date: May 31, 2022

Study information

• Verified date: October 2022
• Source: New York Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

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

Locations

Country	Name	City	State
United States	New York Medical College	Valhalla	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York Medical College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	venous thromboembolism (VTE) formation	No new VTE	7-90 days
Secondary	Doppler ultrasound vein imaging	Change in VTE on Doppler ultrasound	day 8-15