ClinicalTrials.gg
Sign In
CompletedNCT04041843VTEUpdated Oct 25, 2022

Oral Anticoagulant Apixaban for Treatment of Venous Thromboembolism

A Phase 2 interventional study of Apixaban in Venous Thromboembolism, sponsored by New York Medical College. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2022-10-25.

Sponsored by New York Medical College · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was May 2021, 5 years 4 months ago, and no results have been posted to the registry.
  • Registered 2 years 1 month after the study started (first participant enrolled Jun 2017, registered Jul 2019).
Phase
Phase 2
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Sex
All
01

Study summary

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

02

Conditions studied

  • Venous Thromboembolism
03

In context

Venous Thromboembolism

708 studies on the registry are indexed under Venous Thromboembolism; 152 are open to participants now.

This study's enrollment of 25 is below the median of 257 across 390 interventional studies indexed under Venous Thromboembolism.

Browse Venous Thromboembolism studies →

Lead sponsor

New York Medical College is the lead sponsor of 71 studies on the registry; 24 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • 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

Interventions

  • DrugApixaban

    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

06

What researchers measure

Primary outcomes

  1. venous thromboembolism (VTE) formation

    No new VTE

    Time frame: 7-90 days

Secondary outcomes

  1. Doppler ultrasound vein imaging

    Change in VTE on Doppler ultrasound

    Time frame: day 8-15

07

Study locations

1 site
  • New York Medical College
    Valhalla, New York 10595, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2017 to primary completion in May 2021, 47 months.

Of 27 phase 2 interventional studies under Venous Thromboembolism, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 50. This study's 47 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 31, 2019
First posted
Aug 1, 2019
StartActual
Jun 2, 2017
Primary completionActual
May 31, 2021
CompletionActual
May 31, 2022
Last update
Oct 25, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04041843
Lead sponsor
New York Medical College
Responsible party
Sponsor
First posted
Aug 1, 2019
Start date
Jun 2, 2017
Primary completion
May 31, 2021
Completion
May 31, 2022
Last update
Oct 25, 2022

Study contacts

Oya Tugal, MD
principal investigator · New York Medical College

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Apixaban

Other studies in this condition

Venous Thromboembolism →

Other studies from this sponsor

New York Medical College

Start the discussion