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Apixaban for Routine Management of Upper Extremity Deep Venous Thrombosis (ARM-DVT)

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ClinicalTrials.gov Identifier: NCT02945280
Recruitment Status : Recruiting
First Posted : October 26, 2016
Last Update Posted : December 7, 2018
Sponsor:
Collaborators:
Bristol-Myers Squibb
Pfizer
Information provided by (Responsible Party):
Scott C. Woller, MD, Intermountain Health Care, Inc.

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.


Condition or disease Intervention/treatment Phase
Deep Venous Thrombosis Upper Extremity Deep Venous Thrombosis Thrombus Venous Thromboembolism Deep Vein Thrombosis Drug: apixaban Phase 4

Detailed Description:

Background: Upper extremity deep vein thrombosis (UEDVT) constitutes approximately 10% of all DVT. A recent increase in incidence is largely secondary to the increasing use of peripherally inserted central venous catheters. Treatment for UEDVT is derived from evidence for treatment of lower extremity deep vein thrombosis (LEDVT). No evidence exists for the use of a direct oral anticoagulant (DOAC) for the treatment of UEDVT.

Population: Sequential patients identified within the Intermountain Healthcare system and University of Utah Healthcare system with UEDVT defined as the formation of thrombus within the internal jugular, subclavian, axillary, and brachial veins of the arm demonstrated by imaging. Intervention: Apixaban 10 mg PO twice daily for 7 days followed by apixaban 5 mg twice daily for 11 weeks.

Comparison: In the primary analysis, the principal investigator will report the rate of clinically overt objective VTE and VTE-related death in comparison to the rate reported upon literature review ("reference value in the literature"). If the confidence interval for this rate excludes the commonly accepted threshold event rate of 4%, the principal investigator will conclude that treatment with apixaban is noninferior, and therefore a clinically valid approach to treat UEDVT. As a secondary analysis the principal investigator will compare the rate of the primary efficacy outcome and primary safety outcome with a historical control of case matched patients with UEDVT ("historical control") treated with therapy conventional (low molecular weight heparin plus warfarin) prior to the approval of DOACs.

Sample Size: A sample size of 357 patients who meet eligibility criteria was chosen so that an exact 95% confidence interval would exclude an event rate of venous thromboembolism (VTE) in the observation cohort of 4%. The principal investigator will add 5% for anticipated withdrawal to assure adequate patient enrollment in the case of patient withdrawal and enroll 375 patients.

Outcome: 90 day rate of new or recurrent objectively confirmed symptomatic venous thrombosis and VTE-related death. The primary safety outcome is major bleeding and clinically relevant nonmajor bleeding.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 375 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Apixaban for Routine Management of Upper Extremity Deep Venous Thrombosis
Actual Study Start Date : February 22, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Apixaban

Arm Intervention/treatment
Experimental: patients with acute UEDVT
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
12 weeks of apixaban treatment to monitor for efficacy in the prevention of VTE-related mortality
Other Name: Eliquis




Primary Outcome Measures :
  1. Rate of recurrent symptomatic VTE and VTE-related death [ Time Frame: 90 DAYS ]
    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.

  2. rate of major and clinically relevant nonmajor bleeding [ Time Frame: 90 DAYS ]
    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.


Secondary Outcome Measures :
  1. Patient Satisfaction [ Time Frame: 12 weeks ]
    Patient satisfaction with anticoagulation will be assessed based on a standardized questionnaire called the Anti-Clot Scale (ACTS).

  2. Patient Satisfaction [ Time Frame: 12 weeks ]
    Patient satisfaction with anticoagulation will be using the Villalta scale to define and classify the severity of the post-thrombotic syndrome.

  3. Patient Satisfaction [ Time Frame: 12 weeks ]
    Patient satisfaction with anticoagulation may be assessed via a questionnaire known as the VIENES-QOL/Sym which measures the quality of life for DVT in elderly patients.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be ≥ 18 years of age
  • Have received no more than four (4) doses of any anticoagulant, or intravenous and bridging heparin for longer than 60 hours
  • Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
  • Women must not be breastfeeding
  • WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug apixaban plus 5 half-lives of study drug apixaban (3 days) plus 30 days (duration of ovulatory cycle) for a total of 33 days post-treatment completion.
  • Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug apixaban plus 5 half-lives of the study drug apixaban (3 days) plus 90 days (duration of sperm turnover) for a total of 93 days post-treatment completion.
  • Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However WOCBP must still undergo pregnancy testing as described in this section.

Exclusion Criteria:

  • 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 conflicting clinical trial or has participated in a trial within the last 30 days
  • Receiving concomitant dual antiplatelet therapy
  • Requires aspirin dose of greater than 165 mg daily
  • A hemoglobin level of less than 8 mg per deciliter
  • A platelet count of less than 50,000 per cubic millimeter
  • A calculated creatinine clearance of less than 25 mL per minute
  • Alanine aminotransferase or aspartate aminotransferase level greater than 2 times the upper limit of the normal range
  • A total bilirubin more than 1.5 times the upper limit of the normal range.
  • Active cancer for which treatment (chemotherapy/radiation therapy) is being delivered, is imminent, or has been delivered within the last 6 months
  • For patients receiving ELIQUIS 5 mg or 10 mg twice daily, the dose of ELIQUIS should be decreased by 50% when coadministered with drugs that are strong dual inhibitors of CYP3A4 and P-gp (e.g., ketoconazole, itraconazole, ritonavir, or clarithromycin). For patients receiving ELIQUIS at a dose of 2.5 mg twice daily, avoid coadministation with strong dual inhibitors of CYP3A4 and P-gp.
  • 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 (e.g. DVT Of the lower extremity or PE)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02945280


Contacts
Contact: Scott Woller, MD 801-507-7000 Scott.Woller@imail.org
Contact: Brent Armbruster 801-507-4605 Brent.Armbruster@imail.org

Locations
United States, Utah
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84107
Contact: Scott Woller, MD    801-507-7000    Scott.Woller@imail.org   
Principal Investigator: Stacey Johnson, MD         
Sub-Investigator: Scott Stevens, MD         
University of Utah Not yet recruiting
Salt Lake City, Utah, United States, 84132
Contact: Mary J Tinnes    801-585-2254    maryjane.tinnes@hsc.utah.edu   
Contact: Stacy Johnson, MD    801-581-7822    stacy.johnson@hsc.utah.edu   
Sponsors and Collaborators
Intermountain Health Care, Inc.
Bristol-Myers Squibb
Pfizer
Investigators
Principal Investigator: Scott Woller, MD Intermountain Health Care, Inc.

Responsible Party: Scott C. Woller, MD, Co-Director Thrombosis Program, Intermountain Medical Center; Professor of Medicine, University of Utah School of Medicine, Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT02945280     History of Changes
Other Study ID Numbers: CV185-512
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Scott C. Woller, MD, Intermountain Health Care, Inc.:
apixaban
factor Xa inhibitors
antithrombotic agent
deep vein thrombosis
upper extremity

Additional relevant MeSH terms:
Thrombosis
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Apixaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants