Oral Anticoagulant Apixaban for Treatment of Venous Thromboembolism

NCT ID: NCT04041843

Last Updated: 2022-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-02
• Study Completion Date: 2022-05-31

Brief Summary

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

Conditions

Venous Thromboembolism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Apixaban

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Eliquis

Eligibility 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York Medical College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oya Tugal, MD

Role: PRINCIPAL_INVESTIGATOR

New York Medical College

Locations

New York Medical College

Valhalla, New York, United States

Countries

United States

Other Identifiers

NYMC 191

Identifier Type: -

Identifier Source: org_study_id