CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 2,922 enrolled
Drug / intervention
Weekly patient self-testing of prothrombin time +1 moreprocedure
Likely dose
Not stated in record
Key inclusion· 8
  • ✓Diagnosis of atrial fibrillation (AF) and/or mechanical heart valve (MHV)
  • ✓Scheduled to receive warfarin indefinitely (operationally defined as 2 years)
  • ✓Using warfarin according to criteria in Coumadin package insert (no off-label uses)
  • ✓Expected to survive for the duration of the study
Key exclusion· 4
  • ✕Intracranial hemorrhage, subarachnoid hemorrhage, hemorrhagic stroke, or other major contraindication to warfarin within the last month
  • ✕Currently enrolled in another randomized clinical trial involving drug or device intervention
  • ✕Unable to follow protocol and instructions without a caregiver possessing these skills
  • ✕Suffering from intracranial bleeding or other contraindications described in Coumadin package insert

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00032591
NCT00032591Phase 4Completed
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CSP #481 - The Home INR Study (THINRS)

US Department of Veterans Affairs·interventional·Posted Mar 28, 2002·Updated Apr 15, 2014

In Brief

A Phase 4 clinical trial evaluating Weekly patient self-testing of prothrombin time and High quality anticoagulation management (HQACM) with conventional monthly testing for Atrial Fibrillation. Completed, enrolled 2,922 participants across 29 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 4CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 28, 2002
Enrollment StartAug 1, 2003
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 24.3 years ago

Interventions

Weekly patient self-testing of prothrombin timeprocedure

High quality anticoagulation management (HQACM) with conventional monthly testingother

HQACM with testing every 4 weeks and as indicated for out of range values, medication/clinical changes.