VTE: Oral Anticoagulant Apixaban for Treatment of Venous Thromboembolism

Sponsor

New York Medical College (Other)

Overall Status

Recruiting

CT.gov ID

NCT04041843

Collaborator

(none)

Enrollment

Location

Arm

59.9

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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

Anticipated 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 :

Jun 2, 2017

Anticipated Primary Completion Date :

May 31, 2021

Anticipated 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 Names: Eliquis

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 Names:

Eliquis

Outcome Measures

Primary Outcome Measures

venous thromboembolism (VTE) formation [7-90 days]
No new VTE

Secondary Outcome Measures

Doppler ultrasound vein imaging [day 8-15]
Change in VTE on Doppler ultrasound

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	New York Medical College	Valhalla	New York	United States	10595

Sponsors and Collaborators

New York Medical College

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

New York Medical College

ClinicalTrials.gov Identifier:

NCT04041843

Other Study ID Numbers:

NYMC 191

First Posted:

Aug 1, 2019

Last Update Posted:

Sep 9, 2020

Last Verified:

Sep 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Thromboembolism

Venous Thromboembolism

Apixaban

Study Results

No Results Posted as of Sep 9, 2020