Apixaban for Routine Management of Upper Extremity Deep Venous Thrombosis (NCT02945280) | Clinical Trial Compass
TerminatedPhase 4
Apixaban for Routine Management of Upper Extremity Deep Venous Thrombosis
Stopped: COVID-19 resource allocation
United States52 participantsStarted 2017-02-22
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of recurrent symptomatic VTE and VTE-related death
Timeframe: 90 DAYS
2
rate of major and clinically relevant nonmajor bleeding