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 : November 9, 2017
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|
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)|
|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|
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.
12 weeks of apixaban treatment to monitor for efficacy in the prevention of VTE-related mortality
Other Name: Eliquis
- 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.
- 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.
- Patient Satisfaction [ Time Frame: 12 weeks ]Patient satisfaction with anticoagulation will be assessed based on a standardized questionnaire called the Anti-Clot Scale (ACTS).
- 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.
- 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.
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
|Contact: Scott Woller, MD||801-507-7000||Scott.Woller@imail.org|
|Contact: Brent Armbruster||801-507-4605||Brent.Armbruster@imail.org|
|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 email@example.com|
|Contact: Stacy Johnson, MD 801-581-7822 firstname.lastname@example.org|
|Principal Investigator:||Scott Woller, MD||Intermountain Health Care, Inc.|