Oral Anticoagulant Apixaban for Treatment of Venous Thromboembolism

NCT04041843 | Completed Phase 2 FDA Drug

• 1 other identifier: NYMC 191
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Venous Thromboembolism

Outcome Measures

Primary Outcomes (1)

• venous thromboembolism (VTE) formation

  No new VTE

  7-90 days

Secondary Outcomes (1)

• Doppler ultrasound vein imaging

  day 8-15

Study Arms (1)

Abixaban

EXPERIMENTAL

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

Interventions

Apixaban 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

Also known as: Eliquis

Abixaban

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• New York Medical College: lead

Study Sites (1)

New York Medical College

Valhalla, New York, 10595, United States

Location

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

apixaban

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Oya Tugal, MD

  New York Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 1, 2019
• Study Start: June 2, 2017
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2022
• Last Updated: October 25, 2022

Record last verified: 2022-10

Locations

US (1)