AnticoagulationNCT02392104

Prospective Evaluation of an Extended Interval of INR Follow-up in a VA Anticoagulation Service

A study testing Warfarin in people with Anticoagulation, run by William S. Middleton Memorial Veterans Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to determine the feasibility, safety, and acceptability of implementing an extended interval of INR follow-up in Veterans on a stable dose of warfarin in the Anticoagulation Clinic at the William S. Middleton Memorial Veterans Hospital. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Anticoagulation
What is being tested?: Warfarin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: No sites listed yet
Study dates: 27 Mar 2015to 25 Jun 2017
Phase: Interventional
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

Who may be able to join

18 years of age or older
requirement for indefinite warfarin therapy
target INR of 2-3
stable weekly warfarin dose for the past 6 months (not more than a single, one-time adjustment (boost/omission) in the past 6 months, planned interruption for a procedure or surgery with INR(s) out of range in the past 6 months would not exclude a patient)
a patient of the Madison VA anticoagulation clinic for the previous 12 months

Who cannot join

consistently drink ≥4 alcoholic beverages/day or a documented episode of alcohol binging in the past 6 months
diagnosis of cancer and on active chemotherapy/radiotherapy in the past 3 months
life expectancy of < 1 year
enrolled in other investigational drug protocols
only receiving anticoagulation care at the Madison VA for part of the year (e.g. snowbirds)
receiving visiting nurse services for INR monitoring

Show all 15Show fewer

thrombocytopenia (<100K) within past 12 months
history of bleeding or thromboembolism requiring medical intervention within past 6 months
treatment for active liver disease (e.g. hepatitis)
diagnosis or documentation in EMR suggesting cognitive impairment
activated power of attorney
inability to provide informed consent
non-English speaking
unstable mental health disorder that impairs judgment
history of non-adherence to anticoagulation clinic policies and procedures (i.e. missed appointments, self-adjustment of warfarin dose, nonadherence, etc.).

About this study

All participants will be provided usual care from the anticoagulation clinic, except for the interval between INRs. If the participant continues to be on a stable dose of warfarin and the INRs are within the goal range of 2-3 (including lab variation), follow-up visits will be scheduled following an extended interval protocol. Patient satisfaction will be evaluated at various points throughout the study. Additionally provider satisfaction, confidence, and knowledge of the extended interval protocol will be analyzed. Bleeding and thromboembolic events will be evaluated to ensure the safety of an extended follow-up interval.

Read the detailed description

All participants will be provided usual care from the anticoagulation clinic, except for the interval between INRs. If the participant continues to be on a stable dose of warfarin and the INRs are within the goal range of 2-3 (including lab variation), follow-up visits will be scheduled following an extended interval protocol, from 5-6 weeks, to 7-8 weeks, to 11-12 weeks and then continued with 11-12 week visits if INRs continue to remain in goal range and appropriate for the patient. Patient satisfaction will be evaluated at baseline, 6-, 12-, and 24-months. Additionally provider satisfaction, confidence, and knowledge of the extended interval protocol will be analyzed. Bleeding and thromboembolic events will be evaluated to ensure the safety of an extended follow-up interval.

Conditions: Anticoagulation
Being tested: Warfarin
Keywords: International Normalized Ratio, Warfarin

What participants receive

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

WarfarinDrug
Also called Coumadin
If the patient's INRs stay within goal range, their interval of INR follow-up will be extended based on a protocol to a maximum of 12 weeks.

Study groups in NCT02392104
Study group	Role	What they receive
Intervention Arm	Experimental	All patients in the study will be in the intervention arm. Receives: Drug: Warfarin

What is being measured

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

Rates of Participant Accrual
Number of participants who enroll vs. number of individuals invited
Measured: up to 2.25 years
Number of Participants Able to be Scheduled for at Least One 12-week Interval
This outcome will determine the number of participants able to be scheduled for at least one 12-week interval
Measured: 24 months
Number of Participants Scheduled for at Least 4 Consecutive 12-week Intervals
The outcome will determine the number of participants scheduled for at least 4 consecutive 12-week intervals
Measured: 24 months

Secondary outcomes (4)

Change in Frequency of Appointments From Baseline to End of Study
This outcome will evaluate the change in frequency of appointments from baseline to end of study (at 12 and 24 months)
Measured: 12 and 24 months
Bleeding and Thromboembolic Events From Baseline
This outcome will determine the number of bleeding and thromboembolic events from baseline
Measured: 24 months
Change in Time in Therapeutic Range From Baseline
The outcome will evaluate the change in time in therapeutic range (TTR) from baseline (intention-to-treat)
Measured: 6, 12, and 24 months
Patient Satisfaction Through Total DASS Score
Patient satisfaction through total DASS score. DASS = Duke Anticoagulation Satisfaction Scale. 25-item scale.Higher numbers indicate worsening satisfaction ranging from 25-175. Seven-point ordinal scale ("not at all" = 1, "very much" = 7).
Measured: baseline, 6 months, 12 months, 24 months

Timeline

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

27 Mar 201525 Jun 2017

First posted18 Mar 2015 (estimated)
Study start27 Mar 2015
Primary completion25 Jun 2017
Study completion25 Jun 2017

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AnticoagulationStudies 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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02392104
Sponsor's protocol ID: 2014-1296
Status last verified: Nov 2019
First submitted: 25 Feb 2015
Last updated: 11 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Schoen RR, Nagy MW, Porter AL, Margolis AR. Patient Satisfaction With Extended International Normalized Ratio Follow-up Intervals in a Veteran Population. Ann Pharmacother. 2020 May;54(5):442-449. doi: 10.1177/1060028019889414. Epub 2019 Nov 21.
PubMed 31752504

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?

Official record

Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism, Deep Venous Thrombosis
Active, not recruiting
Timing of Anticoagulation After Emergency Endovascular Therapy for Acute Ischemic Stroke With Atrial Fibrillation
Ischemic Stroke, Atrial Fibrillation

All Anticoagulation trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Evaluation of an Extended Interval of INR Follow-up in a VA Anticoagulation Service
ClinicalTrials.gov ID: NCT02392104
Acronym / sponsor ID: 2014-1296
Conditions: Anticoagulation
Keywords: International Normalized Ratio, Warfarin
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: William S. Middleton Memorial Veterans HospitalUS federal agency
Collaborators: University of Wisconsin, Madison
Study start: 27 Mar 2015 (actual)
Primary completion: 25 Jun 2017 (actual)
Study completion: 25 Jun 2017 (actual)
First posted: 18 Mar 2015 (estimated)
Results: Posted 11 Dec 2019

Clinical summary

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

Detailed description

All participants will be provided usual care from the anticoagulation clinic, except for the interval between INRs. If the participant continues to be on a stable dose of warfarin and the INRs are within the goal range of 2-3 (including lab variation), follow-up visits will be scheduled following an extended interval protocol, from 5-6 weeks, to 7-8 weeks, to 11-12 weeks and then continued with 11-12 week visits if INRs continue to remain in goal range and appropriate for the patient. Patient satisfaction will be evaluated at baseline, 6-, 12-, and 24-months. Additionally provider satisfaction, confidence, and knowledge of the extended interval protocol will be analyzed. Bleeding and thromboembolic events will be evaluated to ensure the safety of an extended follow-up interval.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Intervention Arm	Experimental	Drug: WarfarinAll patients in the study will be in the intervention arm.

Who may qualify

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

Key inclusion criteria (5 listed)

18 years of age or older
requirement for indefinite warfarin therapy
target INR of 2-3
stable weekly warfarin dose for the past 6 months (not more than a single, one-time adjustment (boost/omission) in the past 6 months, planned interruption for a procedure or surgery with INR(s) out of range in the past 6 months would not exclude a patient)
a patient of the Madison VA anticoagulation clinic for the previous 12 months

Key exclusion criteria (15 listed)

consistently drink ≥4 alcoholic beverages/day or a documented episode of alcohol binging in the past 6 months
diagnosis of cancer and on active chemotherapy/radiotherapy in the past 3 months
life expectancy of < 1 year
enrolled in other investigational drug protocols
only receiving anticoagulation care at the Madison VA for part of the year (e.g. snowbirds)

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
WarfarinAlso: CoumadinIf the patient's INRs stay within goal range, their interval of INR follow-up will be extended based on a protocol to a maximum of 12 weeks.	Drug	Intervention Arm

Primary outcome

Rates of Participant Accrual
Time frame: up to 2.25 years
Number of participants who enroll vs. number of individuals invited
Number of Participants Able to be Scheduled for at Least One 12-week Interval
Time frame: 24 months
This outcome will determine the number of participants able to be scheduled for at least one 12-week interval
Number of Participants Scheduled for at Least 4 Consecutive 12-week Intervals
Time frame: 24 months
The outcome will determine the number of participants scheduled for at least 4 consecutive 12-week intervals

4 secondary outcomes

Change in Frequency of Appointments From Baseline to End of Study
Time frame: 12 and 24 months
Bleeding and Thromboembolic Events From Baseline
Time frame: 24 months
Change in Time in Therapeutic Range From Baseline
Time frame: 6, 12, and 24 months
Patient Satisfaction Through Total DASS Score
Time frame: baseline, 6 months, 12 months, 24 months

Results and safety

Results posted to the registry on 11 Dec 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
Extended INR Follow-up Interval Group	50	39

Primary outcome: Rates of Participant Accrual

Time frame: up to 2.25 years. Count of participants. Unit: Participants

Measure	Intervention Arm n = 107
Number of patients invted	107
Patient enrolled in study	51
Patients analyzed for study	50

Population analysed: 107 invited to participate in the study, not all enrolled or started the study

Primary outcome: Number of Participants Able to be Scheduled for at Least One 12-week Interval

Time frame: 24 months. Count of participants. Unit: Participants

Measure	Intervention Arm n = 50
Value	36

Primary outcome: Number of Participants Scheduled for at Least 4 Consecutive 12-week Intervals

Time frame: 24 months. Count of participants. Unit: Participants

Measure	Intervention Arm n = 50
Value	15

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention Arm	15 of 50 (30%)	19 of 50 (38%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31752504Schoen RR, Nagy MW, Porter AL, Margolis AR. Patient Satisfaction With Extended International Normalized Ratio Follow-up Intervals in a Veteran Population. Ann Pharmacother. 2020 May;54(5):442-449. doi: 10.1177/1060028019889414. Epub 2019 Nov 21.

Related trials for Anticoagulation

Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism, Deep Venous Thrombosis
Active, not recruiting
Timing of Anticoagulation After Emergency Endovascular Therapy for Acute Ischemic Stroke With Atrial Fibrillation
Ischemic Stroke, Atrial Fibrillation

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.

Carla Staresinic, PharmD principal investigator

William S. Middleton Memorial Veterans Hospital

Questions about this trial

What is this clinical trial studying?

A study testing Warfarin in people with Anticoagulation, run by William S. Middleton Memorial Veterans Hospital.

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 15 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: finished, as of the sponsor's last update on 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Dec 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?

Rates of Participant Accrual (time frame: up to 2.25 years). The study lists 3 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 NCT02392104, which also lists 1 linked publication.

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 11 Dec 2019.