N/A Completed N=200 Randomized Triple-blind Diagnostic

Improved Time in Therapeutic Range With Patient Self-Testing of Their INR Compared to Usual Care

Management of Anticoagulation

Source: ClinicalTrials.gov NCT00703963 ↗

Enrolled (actual)

200

Serious AEs

6.2%

Results posted

Aug 2014

Primary outcomePrimary: Mean Percentage of Time in Therapeutic Range — 48; 53 percentage of time — p=0.20

Summary

Patients who receive a mechanical heart valve to replace a diseased heart valve must take an anticoagulation medicine the rest of their lives, and monitor their level of anticoagulation. Until recently, the testing of the level of anticoagulation was performed at medical laboratories or hospitals. The purpose of this study is to see if patients who test their level of anticoagulation by themselves at home and then call their doctor with the result have better control of their anticoagulation as compared to patients whose anticoagulation is checked only by their physician.

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Percentage of Time in Therapeutic Range	48; 53	0.20
SECONDARY Mean Percentage of INR Tests Within the Therapeutic Range	45; 52	0.05
SECONDARY Mean Number of INR Tests Performed	10; 14	<0.001 sig

Eligibility Criteria

Inclusion Criteria

Patients that received a mechanical valve while in our hospital
Age > 18 years

Exclusion Criteria

Pregnant or lactating women
Patients that have genetic clotting disorders such as Factor 5
Physical disabilities (for example, poor eyesight, tremor, or other neurological disability) that would prevent the patient from being able to perform finger stick blood sampling. (Patients may not be excluded for physical disabilities if a care giver is willing to learn and assist with performing patient self-testing.)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00703963). 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. Informational only — not medical advice.