Deep Venous ThrombosisPhase 4ARM-DVTNCT02945280
Apixaban for Routine Management of Upper Extremity Deep Venous Thrombosis
A Phase 4 study testing apixaban in people with Deep Venous Thrombosis and Upper Extremity Deep Venous Thrombosis, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Venous Thrombosis, Upper Extremity Deep Venous Thrombosis, Thrombus
- What is being tested?
- apixaban
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2017to 11 Nov 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 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.
- Conditions
- Deep Venous Thrombosis, Upper Extremity Deep Venous Thrombosis, Thrombus, Venous Thromboembolism, Deep Vein Thrombosis
- Being tested
- apixaban
- Keywords
- apixaban, factor Xa inhibitors, antithrombotic agent, deep vein thrombosis, upper extremity
- Medical subject headings
- Venous Thrombosis, Thrombosis, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apixabanDrug
Also called Eliquis
12 weeks of apixaban treatment to monitor for efficacy in the prevention of VTE-related mortality
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: apixaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 90 DAYS
Secondary outcomes (3)
Patient Satisfaction
Patient satisfaction with anticoagulation will be assessed based on a standardized questionnaire called the Anti-Clot Scale (ACTS).
Measured: 12 weeks
Patient Satisfaction
Patient satisfaction with anticoagulation will be using the Villalta scale to define and classify the severity of the post-thrombotic syndrome.
Measured: 12 weeks
Patient Satisfaction
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study start22 Feb 2017
- Primary completion11 Nov 2021
- Study completion11 Nov 2021
Why it stopped: COVID-19 resource allocation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Venous ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott C. Woller, MD, Intermountain Health Care, Inc.
- Investigators
- Scott Woller, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945280
- Sponsor's protocol ID
- CV185-512
- Acronym
- ARM-DVT
- Status last verified
- Sep 2023
- First submitted
- 27 Sep 2016
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apixaban for Routine Management of Upper Extremity Deep Venous Thrombosis
- ClinicalTrials.gov ID
- NCT02945280
- Acronym / sponsor ID
- ARM-DVT / CV185-512
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 resource allocation
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- 11 Nov 2021 (actual)
- Study completion
- 11 Nov 2021 (actual)
- First posted
- 26 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with acute UEDVT | Experimental | Drug: apixabanPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| apixabanAlso: Eliquis12 weeks of apixaban treatment to monitor for efficacy in the prevention of VTE-related mortality | Drug | patients with acute UEDVT |
Primary outcome
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.
3 secondary outcomes
Patient Satisfaction
Time frame: 12 weeks
Patient Satisfaction
Time frame: 12 weeks
Patient Satisfaction
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: COVID-19 resource allocation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Woller, MD principal investigator
Intermountain Health Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing apixaban in people with Deep Venous Thrombosis and Upper Extremity Deep Venous Thrombosis, run by Intermountain Health Care, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: COVID-19 resource allocation). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of recurrent symptomatic VTE and VTE-related death (time frame: 90 DAYS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.