Phase 4
N=3,745
The Home INR Study
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT00032591 ↗Enrolled (actual)
3,745
Serious AEs
17.0%
Results posted
Feb 2014
Primary outcome: Primary: Time to First Event (Death, Stroke, Major Bleed) — 0.0785; 0.0987; 0.1542; 0.1820 cumulative probability of event — p=0.14
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Weekly patient self-testing of prothrombin time (Procedure); High quality anticoagulation management (HQACM) with conventional monthly testing (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First Event (Death, Stroke, Major Bleed) |
0.0785; 0.0987; 0.1542; 0.1820; 0.2268; 0.2524 | 0.14 |
| SECONDARY Time in Therapeutic Range Over Full Length of Follow-up (0 to 100 Percent) |
66.2; 62.4 | — |
| SECONDARY DASS at 2 Years of Follow-up |
46.8; 49.2 | — |
| SECONDARY Cumulative Gain in Health Utilities at 2 Year |
1.204; 1.049 | — |
| SECONDARY Health Care Costs at 2 Year |
25,754; 24,505 | — |
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. 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.
Eligibility 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
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
Data sourced from ClinicalTrials.gov (NCT00032591). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.