Atrial FibrillationPhase 4THINRSNCT00032591
The Home INR Study
A Phase 4 study testing Weekly patient self-testing of prothrombin time and High quality anticoagulation management (HQACM) with conventional monthly testing in people with Atrial Fibrillation, run by US Department of Veterans Affairs at 29 sites in 2 countries.
Trial summary
Since home monitors of prothrombin time (PT) may potentially improve the safety, quality, and convenience of chronic anticoagulation management, it is likely that there will be demands from providers, patients, and manufacturers to make home monitors available to VA patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Weekly patient self-testing of prothrombin time and High quality anticoagulation management (HQACM) with conventional monthly testing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,922 participants
- Where
- 29 sitesin 2 countries
- Study dates
- Aug 2003to May 2008
- 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
Who may be able to join
- To be enrolled in this study, patients must:
- have AF and/or a MHV;
- be scheduled to receive warfarin indefinitely (operationally defined as 2 years);
- be using warfarin according to the criteria described in the Coumadin package insert (no off-label uses);
- be expected to survive for the duration of the study;
- not be suffering from intracranial bleeding (intracranial hemorrhage, subarachnoid hemorrhage, hemorrhagic stroke) or any other contraindication described in the Coumadin package insert;
Show all 12Show fewer
- be willing to perform PST;
- be willing to be randomized;
- possess adequate cognitive and language skills to follow the protocol and all related instructions;
- be willing to participate for the full duration of the study;
- sign the informed consent form; and
- not be enrolled in another randomized clinical trial that involves a drug or device intervention.
Who cannot join
- Patients are excluded in this study if:
- subject has had intracranial hemorrhage, subarachnoid hemorrhage, hemorrhagic stroke, or any other absolute/major contraindication described in the warfarin package insert within the last month
- subject enrolled in another randomized clinical trial that involves a drug or device intervention
- subject is not able to follow the protocol and all related instructions, and does not have a caregiver with these skills
Trial locations and contacts
29 sites in 2 countries.
29 sites in 2 countries
United States28 sites
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, 21201
VA Medical Center, Birmingham
Birmingham, Alabama, 35233
VA Western New York Healthcare System at Buffalo
Buffalo, New York, 14215
VA Medical Center, Cleveland
Cleveland, Ohio, 44106
VA North Texas Health Care System, Dallas
Dallas, Texas, 75216
VA Eastern Colorado Health Care System, Denver
Denver, Colorado, 80220
John D. Dingell VA Medical Center, Detroit
Detroit, Michigan, 48201
Durham VA Medical Center HSR&D COE
Durham, North Carolina, 27705
VA Central California Health Care System, Fresno
Fresno, California, 93703
Edward Hines, Jr. VA Hospital
Hines, Illinois, 60141-5000
VA Medical Center, Iowa City
Iowa City, Iowa, 52246-2208
VA Medical Center, Kansas City MO
Kansas City, Missouri, 64128
VA Medical Center, Loma Linda
Loma Linda, California, 92357
Wlliam S. Middleton Memorial Veterans Hospital, Madison
Madison, Wisconsin, 53705
VA Medical Center, Minneapolis
Minneapolis, Minnesota, 55417
VA Medical Center, North Chicago
North Chicago, Illinois, 60064
Las Vegas
North Las Vegas, Nevada, 89036
VA Medical Center, Oklahoma City
Oklahoma City, Oklahoma, 73104
VA Palo Alto Health Care System
Palo Alto, California, 94304-1290
VA Pittsburgh Health Care System
Pittsburgh, Pennsylvania, 15240
VA Medical Center, Providence
Providence, Rhode Island, 02908
VA Sierra Nevada Health Care System
Reno, Nevada, 89502
VA Medical Center, Salem VA
Salem, Virginia, 24153
VA South Texas Health Care System, San Antonio
San Antonio, Texas, 78229
VA Medical Center, Syracuse
Syracuse, New York, 13210
VA Medical Center, Bronx
The Bronx, New York, 10468
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, 06516
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, 90073
About this study
Official title: CSP #481 - The Home INR Study (THINRS)
Since home monitors of prothrombin time (PT) may potentially improve the safety, quality, and convenience of chronic anticoagulation management, it is likely that there will be demands from providers, patients, and manufacturers to make home monitors available to VA patients. The rationale for patient self-testing (PST) is that, compared to conventional high quality anticoagulation management (HQACM), it would permit more intense monitoring and increased patient participation in his/her own care, resulting in increased precision in anticoagulation control and thus fewer events of thromboembolism (strokes) and bleeding. The secondary hypothesis is that PST and HQACM will be comparable in terms of health care utilization and cost.
Read the detailed description
Intervention: Weekly patient self-testing (PST) of prothrombin time by international normalized ratio (PT INR) versus conventional monthly high quality anticoagulation management (HQACM) from an anticoagulation clinic with a minimum two years follow-up.
Primary Hypothesis: Compared to conventional monitoring in the clinic, PST of anticoagulation intensity will decrease the number of events of thromboembolism (strokes), bleeding, and all cause deaths and improve the quality of anticoagulation.
Second Hypothesis: PST and conventional monitoring will be comparable in terms of health care utilization and cost.
Primary Outcomes: Event rates (thromboembolism or bleeding episodes), time to first event, time within therapeutic range for anticoagulation intensity, and total health care cost (including price of PST monitors) and utilization.
Study Abstract: Since home monitors of prothrombin time (PT) may potentially improve the safety, quality, and convenience of chronic anticoagulation management, it is likely that there will be demands from providers, patients, and manufacturers to make home monitors available to VA patients. The rationale for PST is that it would permit more intense monitoring and increased patient participation in his/her own care, resulting in increased precision in anticoagulation control and thus fewer events.
Original plan was for a study at 32 sites with a total sample size of about 3,200 patients and a length of three years (one for recruitment and two years of follow-up). Final status was 28 sites that randomized 2922 patients in 2.75 years of recruitment with a minimum of two years of follow-up.
- Conditions
- Atrial Fibrillation
- Being tested
- Weekly patient self-testing of prothrombin time, High quality anticoagulation management (HQACM) with conventional monthly testing
- Keywords
- AF, Mechanical heart valve (MHV)
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weekly patient self-testing of prothrombin timeProcedure or surgery
High quality anticoagulation management (HQACM) with conventional monthly testingOther
Also called HQACM
HQACM with testing every 4 weeks and as indicated for out of range values, medication/clinical changes.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing Receives: Procedure: Weekly patient self-testing of prothrombin time |
| Arm 2 | Other | High quality anticoagulation management (HQACM) with conventional monthly testing Receives: Other: High quality anticoagulation management (HQACM) with conventional monthly testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Event (Death, Stroke, Major Bleed)
Time to first event (death, stroke, major bleed)
The primary outcome was time to first event, and we used the Kaplan-Meier method to compare survival curves and the results using the log-rank test. The number of patients with a primary outcome is what was reported in the NEJM paper. Below is the unpublished cumulative incidence information.
Measured: Time to event
Secondary outcomes (4)
Time in Therapeutic Range Over Full Length of Follow-up (0 to 100 Percent)
Time in target range (TTR) based on Prothrombin Time standardized to the International Normalized Ratio
Measured: Full length of follow-up; average of 3 years
DASS at 2 Years of Follow-up
Satisfaction with care was quantified using the Duke Anticoagulation Satisfaction Scale (DASS). Scores range from 25 to 225, with lower scores indicating higher satisfaction.
Measured: At two years of follow-up
Cumulative Gain in Health Utilities at 2 Year
Scores range from -0.36 to 1.00 per year, with a negative score indicating a state worse than being dead and a score of 1.00 indicating perfect health. Since the time frame is 2 years, the range is -0.72 to 2.00.
Measured: After 2 years of follow-up for each subject
Health Care Costs at 2 Year
Measured: After 2 years of follow-up for each subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2002 (estimated)
- Study startAug 2003
- Primary completionMay 2008
- Study completionMay 2008
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 (5)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,922 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- David B. Matchar, MD, Study chair, Durham VA Medical Center HSR&D COE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00032591
- Sponsor's protocol ID
- 481
- Acronym
- THINRS
- Status last verified
- Mar 2014
- First submitted
- 27 Mar 2002
- Last updated
- 15 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Dolor RJ, Ruybalid RL, Uyeda L, Edson RG, Phibbs C, Vertrees JE, Shih MC, Jacobson AK, Matchar DB; THINRS Site Investigators. An evaluation of patient self-testing competency of prothrombin time for managing anticoagulation: pre-randomization results of VA Cooperative Study #481--The Home INR Study (THINRS). J Thromb Thrombolysis. 2010 Oct;30(3):263-75. doi: 10.1007/s11239-010-0499-8.
PubMed 20628787Matchar DB, Jacobson A, Dolor R, Edson R, Uyeda L, Phibbs CS, Vertrees JE, Shih MC, Holodniy M, Lavori P; THINRS Executive Committee and Site Investigators. Effect of home testing of international normalized ratio on clinical events. N Engl J Med. 2010 Oct 21;363(17):1608-20. doi: 10.1056/NEJMoa1002617.
PubMed 20961244Matchar DB, Jacobson AK, Edson RG, Lavori PW, Ansell JE, Ezekowitz MD, Rickles F, Fiore L, Boardman K, Phibbs C, Fihn SD, Vertrees JE, Dolor R. The impact of patient self-testing of prothrombin time for managing anticoagulation: rationale and design of VA Cooperative Study #481--the Home INR Study (THINRS). J Thromb Thrombolysis. 2005 Jun;19(3):163-72. doi: 10.1007/s11239-005-1452-0.
PubMed 16082603Phibbs CS, Love SR, Jacobson AK, Edson R, Su P, Uyeda L, Matchar DB; writing for the THINRS Executive Committee and Site Investigators. At-Home Versus In-Clinic INR Monitoring: A Cost-Utility Analysis from The Home INR Study (THINRS). J Gen Intern Med. 2016 Sep;31(9):1061-7. doi: 10.1007/s11606-016-3700-8. Epub 2016 May 27.
PubMed 27234663Matchar DB, Love SR, Jacobson AK, Edson R, Uyeda L, Phibbs CS, Dolor RJ. The impact of frequency of patient self-testing of prothrombin time on time in target range within VA Cooperative Study #481: The Home INR Study (THINRS), a randomized, controlled trial. J Thromb Thrombolysis. 2015 Jul;40(1):17-25. doi: 10.1007/s11239-014-1128-8.
PubMed 25209313
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSP #481 - The Home INR Study (THINRS)
- ClinicalTrials.gov ID
- NCT00032591
- Acronym / sponsor ID
- THINRS / 481
- Conditions
- Atrial Fibrillation
- Keywords
- AF, Mechanical heart valve (MHV)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,922 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Aug 2003
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 28 Mar 2002 (estimated)
- Results
- Posted 6 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Since home monitors of prothrombin time (PT) may potentially improve the safety, quality, and convenience of chronic anticoagulation management, it is likely that there will be demands from providers, patients, and manufacturers to make home monitors available to VA patients. The rationale for patient self-testing (PST) is that, compared to conventional high quality anticoagulation management (HQACM), it would permit more intense monitoring and increased patient participation in his/her own care, resulting in increased precision in anticoagulation control and thus fewer events of thromboembolism (strokes) and bleeding. The secondary hypothesis is that PST and HQACM will be comparable in terms of health care utilization and cost.
Detailed description
Intervention: Weekly patient self-testing (PST) of prothrombin time by international normalized ratio (PT INR) versus conventional monthly high quality anticoagulation management (HQACM) from an anticoagulation clinic with a minimum two years follow-up.
Primary Hypothesis: Compared to conventional monitoring in the clinic, PST of anticoagulation intensity will decrease the number of events of thromboembolism (strokes), bleeding, and all cause deaths and improve the quality of anticoagulation.
Second Hypothesis: PST and conventional monitoring will be comparable in terms of health care utilization and cost.
Primary Outcomes: Event rates (thromboembolism or bleeding episodes), time to first event, time within therapeutic range for anticoagulation intensity, and total health care cost (including price of PST monitors) and utilization.
Study Abstract: Since home monitors of prothrombin time (PT) may potentially improve the safety, quality, and convenience of chronic anticoagulation management, it is likely that there will be demands from providers, patients, and manufacturers to make home monitors available to VA patients. The rationale for PST is that it would permit more intense monitoring and increased patient participation in his/her own care, resulting in increased precision in anticoagulation control and thus fewer events.
Original plan was for a study at 32 sites with a total sample size of about 3,200 patients and a length of three years (one for recruitment and two years of follow-up). Final status was 28 sites that randomized 2922 patients in 2.75 years of recruitment with a minimum of two years of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Procedure: Weekly patient self-testing of prothrombin timePatient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing |
| Arm 2 | Other | Other: High quality anticoagulation management (HQACM) with conventional monthly testingHigh quality anticoagulation management (HQACM) with conventional monthly testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- have AF and/or a MHV;
- be scheduled to receive warfarin indefinitely (operationally defined as 2 years);
- be using warfarin according to the criteria described in the Coumadin package insert (no off-label uses);
- be expected to survive for the duration of the study;
- not be suffering from intracranial bleeding (intracranial hemorrhage, subarachnoid hemorrhage, hemorrhagic stroke) or any other contraindication described in the Coumadin package insert;
Key exclusion criteria (4 listed)
- subject has had intracranial hemorrhage, subarachnoid hemorrhage, hemorrhagic stroke, or any other absolute/major contraindication described in the warfarin package insert within the last month
- subject enrolled in another randomized clinical trial that involves a drug or device intervention
- subject is not able to follow the protocol and all related instructions, and does not have a caregiver with these skills
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 |
|---|---|---|
| Weekly patient self-testing of prothrombin time | Procedure or surgery | Arm 1 |
| High quality anticoagulation management (HQACM) with conventional monthly testingAlso: HQACMHQACM with testing every 4 weeks and as indicated for out of range values, medication/clinical changes. | Other | Arm 2 |
Primary outcome
Time to First Event (Death, Stroke, Major Bleed)
Time frame: Time to event
Time to first event (death, stroke, major bleed) The primary outcome was time to first event, and we used the Kaplan-Meier method to compare survival curves and the results using the log-rank test. The number of patients with a primary outcome is what was reported in the NEJM paper. Below is the unpublished cumulative incidence information.
4 secondary outcomes
Time in Therapeutic Range Over Full Length of Follow-up (0 to 100 Percent)
Time frame: Full length of follow-up; average of 3 years
DASS at 2 Years of Follow-up
Time frame: At two years of follow-up
Cumulative Gain in Health Utilities at 2 Year
Time frame: After 2 years of follow-up for each subject
Health Care Costs at 2 Year
Time frame: After 2 years of follow-up for each subject
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20628787Dolor RJ, Ruybalid RL, Uyeda L, Edson RG, Phibbs C, Vertrees JE, Shih MC, Jacobson AK, Matchar DB; THINRS Site Investigators. An evaluation of patient self-testing competency of prothrombin time for managing anticoagulation: pre-randomization results of VA Cooperative Study #481--The Home INR Study (THINRS). J Thromb Thrombolysis. 2010 Oct;30(3):263-75. doi: 10.1007/s11239-010-0499-8.
- Results publication: PubMed 20961244Matchar DB, Jacobson A, Dolor R, Edson R, Uyeda L, Phibbs CS, Vertrees JE, Shih MC, Holodniy M, Lavori P; THINRS Executive Committee and Site Investigators. Effect of home testing of international normalized ratio on clinical events. N Engl J Med. 2010 Oct 21;363(17):1608-20. doi: 10.1056/NEJMoa1002617.
- Results publication: PubMed 16082603Matchar DB, Jacobson AK, Edson RG, Lavori PW, Ansell JE, Ezekowitz MD, Rickles F, Fiore L, Boardman K, Phibbs C, Fihn SD, Vertrees JE, Dolor R. The impact of patient self-testing of prothrombin time for managing anticoagulation: rationale and design of VA Cooperative Study #481--the Home INR Study (THINRS). J Thromb Thrombolysis. 2005 Jun;19(3):163-72. doi: 10.1007/s11239-005-1452-0.
- Derived from this study: PubMed 27234663Phibbs CS, Love SR, Jacobson AK, Edson R, Su P, Uyeda L, Matchar DB; writing for the THINRS Executive Committee and Site Investigators. At-Home Versus In-Clinic INR Monitoring: A Cost-Utility Analysis from The Home INR Study (THINRS). J Gen Intern Med. 2016 Sep;31(9):1061-7. doi: 10.1007/s11606-016-3700-8. Epub 2016 May 27.
- Derived from this study: PubMed 25209313Matchar DB, Love SR, Jacobson AK, Edson R, Uyeda L, Phibbs CS, Dolor RJ. The impact of frequency of patient self-testing of prothrombin time on time in target range within VA Cooperative Study #481: The Home INR Study (THINRS), a randomized, controlled trial. J Thromb Thrombolysis. 2015 Jul;40(1):17-25. doi: 10.1007/s11239-014-1128-8.
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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.
David B. Matchar, MD study chair
Durham VA Medical Center HSR&D COE
29 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Weekly patient self-testing of prothrombin time and High quality anticoagulation management (HQACM) with conventional monthly testing in people with Atrial Fibrillation, run by US Department of Veterans Affairs at 29 sites in 2 countries.
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 12 inclusion and 4 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 15 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Puerto Rico. 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 6 Feb 2014). 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?
Time to First Event (Death, Stroke, Major Bleed) (time frame: Time to event). 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 NCT00032591, which also lists 5 linked publications.
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 15 Apr 2014.