The Home INR Study - Full Text View

Sponsor:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00032591

Purpose

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.

Condition	Intervention	Phase
Atrial Fibrillation	Procedure: Weekly patient self-testing of prothrombin time Other: High quality anticoagulation management (HQACM) with conventional monthly testing	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	CSP # - 481, The Home INR Study (THINRS)

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

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. [ Time Frame: 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. ] [ Designated as safety issue: Yes ]

Enrollment:	2922
Study Start Date:	August 2003
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing	Procedure: Weekly patient self-testing of prothrombin time
2 High quality anticoagulation management (HQACM) with conventional monthly testing	Other: 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 Name: HQACM

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.

Current plans call 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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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;
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.

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00032591

Show 29 Study Locations

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Study Chair:

David B. Matchar, MD

Durham VA Medical Center HSR&D COE

More Information

No publications provided by Department of Veterans Affairs

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Matchar, David - Study Chair, Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00032591 History of Changes
Other Study ID Numbers:	481
Study First Received:	March 27, 2002
Last Updated:	September 15, 2008
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

AF
Mechanical heart valve (MHV)

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Thrombin

Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012