The Home INR Study (THINRS)
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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 4 |
| 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) |
- 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 |
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
Show 29 Study Locations| 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):
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00032591 History of Changes |
| Other Study ID Numbers: | 481 |
| Study First Received: | March 27, 2002 |
| Last Updated: | May 31, 2012 |
| 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 May 23, 2013