CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 217 enrolled
Drug / intervention
Warfarindrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT02376803
NCT02376803Phase 4Completed

The Effect of Medication Timing on Anticoagulation Stability in Users of Warfarin: The "INRange" RCT

University of Alberta·interventional·Posted Mar 3, 2015·Updated May 4, 2018

In Brief

A Phase 4 clinical trial evaluating Warfarin for Atrial Fibrillation and 4 related conditions. Completed, enrolled 217 participants across 2 sites.

Detailed Summary

Warfarin is an anticoagulant medication that is highly effective at preventing clotting disorders but which has a narrow therapeutic window. If warfarin is under effective patients are at risk of stroke, if it is over effective patients are at risk of bleeding complications. Physicians routinely and regularly measure a blood test (called the "INR") that determines the effectiveness of warfarin and have a range of test values (the "therapeutic range") in which they try to keep the patient. By convention warfarin is taken at dinnertime, however this is the same time of day that highly variable consumption of dietary vitamin K occurs (found largely in green leafy vegetables) and vitamin K alters the effectiveness of warfarin. Given vitamin K has a very short half-life (i.e. it is only active for a short period of time after it is ingested) it may make more sense to take warfarin in the morning (when very little vitamin K is ingested) to produce a more consistent drug effect. The purpose of this study is to determine whether switching current warfarin users from evening to morning dosing decreases time spent outside the therapeutic INR range.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 3, 2015
Enrollment StartFeb 1, 2015
Primary CompletionSep 30, 2016
Study CompletionApr 27, 2018
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 11.3 years ago

Interventions

Warfarindrug

Morning vs Evening administration