Apixaban for Routine Management of Upper Extremity Deep Venous Thrombosis

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    375
  • sponsor
    Intermountain Health Care, Inc.
Updated on 23 January 2021
thrombosis
heparin
clot
anticoagulants
drug test
deep vein thrombosis
apixaban
apixaban 5 mg
blood clot
venous thrombosis
deep venous thrombosis of lower extremity

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.

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 with UEDVT defined as the formation of thrombus within the internal jugular, subclavian, axillary, and brachial veins of the arm demonstrated by imaging.

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.

Details
Condition Venous Thrombosis, Venous Thromboembolism, Thromboembolism, Thrombosis, Blood Clots, Upper Extremity Deep Venous Thrombosis, Deep Vein Thrombosis, deep venous thrombosis of lower extremity, deep venous thrombosis, clot, blood clot, blood clotting
Treatment Apixaban
Clinical Study IdentifierNCT02945280
SponsorIntermountain Health Care, Inc.
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Venous Thrombosis or Venous Thromboembolism or Blood Clots or Thromboembolism or Deep Vein Thrombosis or Thrombosis or Upper Extremity Deep Venous Thr...?
Do you have any of these conditions: Thromboembolism or Deep Vein Thrombosis or Thrombosis or Blood Clots or deep venous thrombosis of lower extremity or blood clot or blood clotting or V...?
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

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 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
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