Venous ThromboembolismPhase 4COVETNCT03196349

Comparison of Oral Anticoagulants for Extended VEnous Thromboembolism

A Phase 4 study testing Warfarin, Apixaban 2.5 MG and Rivaroxaban 10 MG in people with Venous Thromboembolism, run by Duke University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Comparison of Oral anticoagulants (warfarin, apixaban and rivaroxaban) for extended VEnous Thromboembolism. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Venous Thromboembolism
What is being tested?: Warfarin, Apixaban 2.5 MG and Rivaroxaban 10 MG
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 1 siteUnited States
Study dates: 1 Aug 2018to 1 May 2019
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

3.1 Inclusion Criteria

To be eligible for this trial, patients must meet all of the following criteria:

Have confirmed acute, symptomatic, first lower extremity proximal DVT and/or PE that is NOT associated with a transient risk factor.
Have completed an initial treatment course of oral anticoagulant therapy for 3-12 months and have a recommendation from their provider to continue anticoagulation indefinitely.
Have the capacity to understand and sign an informed consent form.
Be 18 years of age and older.
Under the direct care of a healthcare provider for treatment of VTE for the length of time in the study.

3.2 Exclusion Criteria

If a patient meets any of the following criteria, he or she may not be enrolled in the study:

Creatinine clearance (CrCl) < 30 mL/min as determined by Cockcroft-Gault formula documented within 3 months from date of consent
Significant liver disease (Child-Pugh B or C)
Concomitant use of medications that are strong P-glycoprotein or CYP3A4 inducers/inhibitors
Another indication for chronic therapeutic-dose anticoagulation, such as atrial fibrillation (i.e., rivaroxaban, 10 mg daily, or apixaban, 2.5 mg twice daily, would not be appropriate therapy)
A clinical indication for a specific anticoagulant regimen (e.g., warfarin with a target INR of 2-3 is recommended for patients with 'triple-positive' antiphospholipid syndrome).
Life expectancy < 3 months
Currently pregnant or breast feeding
Unable / unwilling to pay for one (or more) of the treatment options
Active Cancer defined as:

Diagnosed with cancer within the past 6 months; or Recurrent, regionally advanced or metastatic disease; Currently receiving treatment or have received any treatment for cancer during the 6 months prior to randomization; or A hematologic malignancy not in complete remission

Unwilling / unlikely to agree to follow up

Trial locations and contacts

1 site in 1 country.

United States1 site

University of California Irvine Medical Center
Orange, California, 92868

Other trials in United States

About this study

Official title: Comparison of Oral Anticoagulants for Extended VEnous Thromboembolism (COVET)

Comparison of Oral anticoagulants (warfarin, apixaban and rivaroxaban) for extended VEnous Thromboembolism.

Read the detailed description

Determine if apixaban is superior to warfarin in the reduction of clinically relevant bleeding. Determine if rivaroxaban is superior to warfarin in the reduction of clinically relevant bleeding. Determine if apixaban is non-inferior to warfarin in the prevention of recurrent venous thromboembolism. Determine if rivaroxaban is non-inferior to warfarin in the prevention of recurrent venous thromboembolism. An exploratory comparison of apixaban versus rivaroxaban for the prevention of clinically relevant bleeding and recurrent Venous Thromboembolism (VTEs) as a secondary objective.

Conditions: Venous Thromboembolism
Being tested: Warfarin, Apixaban 2.5 MG, Rivaroxaban 10 MG
Medical subject headings: Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

WarfarinDrug
Will be randomized to receive open label warfarin daily to achieve a target INR of 2-3
Apixaban 2.5 MGDrug
Will be randomized to receive open label apixaban of 2.5 mg twice daily
Rivaroxaban 10 MGDrug
Will be randomized to receive open label rivaroxaban of 10mg daily

Study groups in NCT03196349
Study group	Role	What they receive
Warfarin	Active comparator	Subjects randomized to Warfarin will have warfarin administered daily in order to maintain a target INR of 2-3 Receives: Drug: Warfarin
Apixaban	Active comparator	Subjects randomized to Apixaban will have apixaban administered study drug of 2.5mg twice daily Receives: Drug: Apixaban 2.5 MG
Rivaroxaban	Active comparator	Subjects randomized to Rivaroxaban will have rivaroxaban administered study drug of 10 mg daily Receives: Drug: Rivaroxaban 10 MG

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With Clinically Relevant Bleeding Events
Primary outcome of Clinically relevant bleeding (composite of major bleeding (MB) and/or clinically relevant non major bleeding (CRNMB))
Measured: Randomization to 12 months
Number of Subjects With Recurrent Venous Thromboembolism (VTE)
Primary efficacy outcome of recurrent VTE
Measured: Randomization to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 20181 May 2019

First posted22 Jun 2017
Study start1 Aug 2018
Primary completion1 May 2019
Study completion1 May 2019

Why it stopped: Lack of enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03196349
Sponsor's protocol ID: Pro00077510
Acronym: COVET
Status last verified: Dec 2019
First submitted: 20 Jun 2017
Last updated: 13 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
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REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
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Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
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DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
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All Venous Thromboembolism trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Oral Anticoagulants for Extended VEnous Thromboembolism (COVET)
ClinicalTrials.gov ID: NCT03196349
Acronym / sponsor ID: COVET / Pro00077510
Conditions: Venous Thromboembolism
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Lack of enrollment
Enrolment: 44 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: Patient-Centered Outcomes Research Institute
Study start: 1 Aug 2018 (actual)
Primary completion: 1 May 2019 (actual)
Study completion: 1 May 2019 (actual)
First posted: 22 Jun 2017 (actual)
Results: Posted 14 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Comparison of Oral anticoagulants (warfarin, apixaban and rivaroxaban) for extended VEnous Thromboembolism.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Warfarin	Active comparator	Drug: WarfarinSubjects randomized to Warfarin will have warfarin administered daily in order to maintain a target INR of 2-3
Apixaban	Active comparator	Drug: Apixaban 2.5 MGSubjects randomized to Apixaban will have apixaban administered study drug of 2.5mg twice daily
Rivaroxaban	Active comparator	Drug: Rivaroxaban 10 MGSubjects randomized to Rivaroxaban will have rivaroxaban administered study drug of 10 mg daily

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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
WarfarinWill be randomized to receive open label warfarin daily to achieve a target INR of 2-3	Drug	Warfarin
Apixaban 2.5 MGWill be randomized to receive open label apixaban of 2.5 mg twice daily	Drug	Apixaban
Rivaroxaban 10 MGWill be randomized to receive open label rivaroxaban of 10mg daily	Drug	Rivaroxaban

Primary outcome

Number of Subjects With Clinically Relevant Bleeding Events
Time frame: Randomization to 12 months
Primary outcome of Clinically relevant bleeding (composite of major bleeding (MB) and/or clinically relevant non major bleeding (CRNMB))
Number of Subjects With Recurrent Venous Thromboembolism (VTE)
Time frame: Randomization to 12 months
Primary efficacy outcome of recurrent VTE

Results and safety

Results posted to the registry on 14 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Warfarin	17	0
Apixaban	14	0
Rivaroxaban	13	0

Primary outcome: Number of Subjects With Clinically Relevant Bleeding Events

Time frame: Randomization to 12 months. Count of participants. Unit: Participants

Measure	Warfarin n = 14	Apixaban n = 8	Rivaroxaban n = 9
Value	0	0	0

Population analysed: 44 subjects were randomized but analysis was only done on participants that had started therapy by the 1 month telephone visit

Primary outcome: Number of Subjects With Recurrent Venous Thromboembolism (VTE)

Time frame: Randomization to 12 months. Count of participants. Unit: Participants

Measure	Warfarin n = 17	Apixaban n = 14	Rivaroxaban n = 13
Value	0	1	0

Adverse events

Time frame: Up to 9 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Warfarin	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Apixaban	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Rivaroxaban	0 of 9 (0%)	0 of 9 (0%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Venous Thromboembolism

RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
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RecruitingPhase 3
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RecruitingPhase 3
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Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
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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.

Thomas Ortel, MD principal investigator

Duke University

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 Warfarin, Apixaban 2.5 MG and Rivaroxaban 10 MG in people with Venous Thromboembolism, run by Duke University 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?

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 13 Dec 2019. 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?

Yes. Results are posted in the registry (first posted 14 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Subjects With Clinically Relevant Bleeding Events (time frame: Randomization to 12 months). 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?

On the ClinicalTrials.gov record for NCT03196349.

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 13 Dec 2019; AzTrials last refreshed its copy on 8 Nov 2026.