Apixaban for Routine Management of Upper Extremity Deep Venous Thrombosis

NCT02945280 | Terminated Phase 4 DMC FDA Drug

• 1 other identifier: CV185-512
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the safety and effectiveness of a drug called apixaban for the treatment of upper extremity deep vein thrombosis (UEDVT) and clinically important bleeding. Subjects will receive apixaban 10 mg by mouth twice a day for 7 days, followed by 5 mg by mouth twice a day for a duration of 11 weeks. There will be a followup visit at 12 weeks for all participants. A total of 375 are to be enrolled. The study drug has been approved to treat blood clots. The study drug has not been studied uniquely for the treatment of blood clots in the upper extremity however. Because it is unknown whether it is effective to treat blood clots in the upper extremity, the principal investigator cannot guarantee that there will be benefit to study subjects; however, it is hoped that the information obtained from this research study will help treat patients in the future.

Conditions

Deep Venous Thrombosis; Upper Extremity Deep Venous Thrombosis; Thrombus; Venous Thromboembolism; Deep Vein Thrombosis

Keywords

apixaban; factor Xa inhibitors; antithrombotic agent; deep vein thrombosis; upper extremity

Outcome Measures

Primary Outcomes (2)

• Rate of recurrent symptomatic VTE and VTE-related death

  90-day rate of recurrent symptomatic venous thrombosis and venous thromboembolism-related death. If the event rate observed for venous thromboembolism (VTE) excludes 4% derived from the reference value in the literature, the principal investigator will assume noninferiority. As a secondary outcome the event rate the principal investigator observes will be compared with the historical control.

  90 DAYS

• rate of major and clinically relevant nonmajor bleeding

  90-day rate of major and clinically relevant nonmajor bleeding. If the upper bound of the 95% confidence interval for event rate for the composite outcome of major bleeding and clinically relevant nonmajor bleeding excludes 13%, the principal investigator will consider apixaban as noninferior to warfarin.

  90 DAYS

Secondary Outcomes (3)

• Patient Satisfaction

  12 weeks

• Patient Satisfaction

  12 weeks

• Patient Satisfaction

  12 weeks

Study Arms (1)

patients with acute UEDVT

EXPERIMENTAL

Patients will receive 10 mg PO apixaban for 7 days and then 5 mg PO for 11 weeks, for a total of 12 weeks of treatment.

Drug: apixaban

Interventions

apixaban DRUG

12 weeks of apixaban treatment to monitor for efficacy in the prevention of VTE-related mortality

Also known as: Eliquis

patients with acute UEDVT

Eligibility Criteria

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

You may qualify if:

• Be ≥ 18 years of age
• Have received no more than six (6) doses of any therapeutic anticoagulant, or intravenous and bridging heparin for longer than 72 hours
• Women must not be breastfeeding
• Receiving apixaban as administered per clinical routine (apixaban 10 mg by mouth twice daily for 7 days, followed by apixaban 5 mg twice daily for 11 weeks)
• Provide informed consent within 72 hours of receiving apixaban

You may not qualify if:

• Another indication for long-term anticoagulation for which no FDA approval of apixaban exists (e.g. prosthetic heart valves)
• Life expectancy of less than 6 months
• Unable to engage in reliable follow-up as per protocol
• Participating in a clinical trial or has participated in a clinical trial within the last 30 days
• Receiving concomitant dual antiplatelet therapy
• Requires aspirin dose of greater than 165 mg daily
• Intend pregnancy or breastfeeding within the next year
• Known allergy to apixaban, rivaroxaban, or edoxaban
• Active pathological bleeding.
• Any condition that at the discretion of the investigator is thought to prohibit active participation and follow-up in the trial
• UEDVT that occurs while therapeutic anticoagulation is being taken by the patient ("event on therapy")
• The patient has concomitant VTE diagnosed elsewhere except deep vein thrombosis that has its most proximal aspect in the distal veins ("isolated distal DVT")
• Any contraindication to apixaban referenced in the package insert

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead

Study Sites (1)

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

MeSH Terms

Conditions

Venous Thrombosis; Thrombosis; Venous Thromboembolism

Interventions

apixaban

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thromboembolism

Study Officials

• Scott Woller, MD

  Intermountain Health Care, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director Thrombosis Program, Intermountain Medical Center; Professor of Medicine, University of Utah School of Medicine

Study Record Dates

• First Submitted: September 27, 2016
• First Posted: October 26, 2016
• Study Start: February 22, 2017
• Primary Completion: November 11, 2021
• Study Completion: November 11, 2021
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)