Phase 4
Completed N=26
Personalized Medicine Interface Tool (PerMIT): Warfarin: A Trial Comparing Usual Care Warfarin Initiation to PerMIT Pharmacogenetic Guided Warfarin Therapy
Blood Clotting
Source: ClinicalTrials.gov NCT00993200 ↗
Enrolled (actual)
26
Serious AEs
0.0%
Results posted
May 2013
Primary outcomePrimary: The Number of Days to First International Normalized Ratio (INR) Within Therapeutic Range — 8.3; 4.7 days
Summary
Warfarin is the most commonly used oral anticoagulant medicine (blood thinner). Although this medicine works well, it is difficult to know how much medicine a patient needs. Many things affect how much medicine a patient needs and doses can be very different from patient to patient. It is important for patients to get the right dose to prevent clotting or bleeding problems that can happen with this medicine if the dose is too low or too high. These problems can be life-threatening. To help find the right dose, patients on warfarin must have frequent blood tests to measure how well the medicine is working. The investigators know differences in people's genes can affect how much warfarin medicine someone needs, but they don't yet know with certainty how to use this information in making patient care decisions. The hypothesis of this study is that using a patients warfarin related genetic information incorporated into a computer algorithm to be used by a warfarin provider will lead to better warfarin management compared to usual care.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Days to First International Normalized Ratio (INR) Within Therapeutic Range |
8.3; 4.7 | — |
| SECONDARY Adverse Major and Minor Bleeding Events |
0; 0 | — |
| SECONDARY Thrombotic Complication |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Prescribed warfarin for any indication, so long as they are naïve to the drug at enrollment and are expected to receive therapy for at least 12 weeks
Exclusion Criteria
- Recent cardiothoracic surgery as indication for warfarin.
Data sourced from ClinicalTrials.gov (NCT00993200). 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.