Oral Anticoagulant Apixaban for Treatment of Venous Thromboembolism

Phase 2

Completed

• Conditions: Venous Thromboembolism
• Interventions: Drug: Apixaban

• Registration Number: NCT04041843
• Lead Sponsor: New York Medical College

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-02
• Study First Submitted: 2019-07-31
• Study First Submitted QC: 2019-07-31
• Study First Posted: 2019-08-01
• Primary Completion: 2021-05-31
• Study Completion: 2022-05-31
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-24
• Last Update Posted: 2022-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Abixaban	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 who have been diagnosed with a thrombosis.

Primary Outcome Measures

Name	Time	Method
venous thromboembolism (VTE) formation	7-90 days	No new VTE

Secondary Outcome Measures

Name	Time	Method
Doppler ultrasound vein imaging	day 8-15	Change in VTE on Doppler ultrasound

Trial Locations

Locations (1)

New York Medical College; 🇺🇸 Valhalla, New York, United States