Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
2922 participants
INTERVENTIONAL
2003-08-31
2008-05-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1
Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
Weekly patient self-testing of prothrombin time
Arm 2
High quality anticoagulation management (HQACM) with conventional monthly testing
High quality anticoagulation management (HQACM) with conventional monthly testing
HQACM with testing every 4 weeks and as indicated for out of range values, medication/clinical changes.
Interventions
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Weekly patient self-testing of prothrombin time
High quality anticoagulation management (HQACM) with conventional monthly testing
HQACM with testing every 4 weeks and as indicated for out of range values, medication/clinical changes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. have AF and/or a MHV;
2. be scheduled to receive warfarin indefinitely (operationally defined as 2 years);
3. be using warfarin according to the criteria described in the Coumadin package insert (no off-label uses);
4. be expected to survive for the duration of the study;
5. not be suffering from intracranial bleeding (intracranial hemorrhage, subarachnoid hemorrhage, hemorrhagic stroke) or any other contraindication described in the Coumadin package insert;
6. be willing to perform PST;
7. be willing to be randomized;
8. possess adequate cognitive and language skills to follow the protocol and all related instructions;
9. be willing to participate for the full duration of the study;
10. sign the informed consent form; and
11. not be enrolled in another randomized clinical trial that involves a drug or device intervention.
Exclusion Criteria
1. 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
2. subject enrolled in another randomized clinical trial that involves a drug or device intervention
3. subject is not able to follow the protocol and all related instructions, and does not have a caregiver with these skills
18 Years
ALL
No
Sponsors
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US Department of Veterans Affairs
FED
Responsible Party
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Principal Investigators
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David B. Matchar, MD
Role: STUDY_CHAIR
Durham VA Medical Center HSR&D COE
Locations
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VA Medical Center, Birmingham
Birmingham, Alabama, United States
VA Central California Health Care System, Fresno
Fresno, California, United States
VA Medical Center, Loma Linda
Loma Linda, California, United States
VA Palo Alto Health Care System
Palo Alto, California, United States
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, United States
VA Eastern Colorado Health Care System, Denver
Denver, Colorado, United States
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, United States
Edward Hines, Jr. VA Hospital
Hines, Illinois, United States
VA Medical Center, North Chicago
North Chicago, Illinois, United States
VA Medical Center, Iowa City
Iowa City, Iowa, United States
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, United States
John D. Dingell VA Medical Center, Detroit
Detroit, Michigan, United States
VA Medical Center, Minneapolis
Minneapolis, Minnesota, United States
VA Medical Center, Kansas City MO
Kansas City, Missouri, United States
Las Vegas
North Las Vegas, Nevada, United States
VA Sierra Nevada Health Care System
Reno, Nevada, United States
VA Western New York Healthcare System at Buffalo
Buffalo, New York, United States
VA Medical Center, Syracuse
Syracuse, New York, United States
VA Medical Center, Bronx
The Bronx, New York, United States
Durham VA Medical Center HSR&D COE
Durham, North Carolina, United States
VA Medical Center, Cleveland
Cleveland, Ohio, United States
VA Medical Center, Oklahoma City
Oklahoma City, Oklahoma, United States
VA Pittsburgh Health Care System
Pittsburgh, Pennsylvania, United States
VA Medical Center, Providence
Providence, Rhode Island, United States
VA North Texas Health Care System, Dallas
Dallas, Texas, United States
VA South Texas Health Care System, San Antonio
San Antonio, Texas, United States
VA Medical Center, Salem VA
Salem, Virginia, United States
Wlliam S. Middleton Memorial Veterans Hospital, Madison
Madison, Wisconsin, United States
VA Medical Center, San Juan
San Juan, , Puerto Rico
Countries
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References
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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.
Matchar 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.
Matchar 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.
Phibbs 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.
Matchar 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.
Other Identifiers
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481
Identifier Type: -
Identifier Source: org_study_id
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