Patients switch from taking warfarin in the evening to taking warfarin in the morning.

Patients continue taking warfarin in the evening as per their usual routine.

Atrial Fibrillation

Thrombus Due to Heart Valve Prosthesis

Deep Venous Thrombosis

Thromboembolism

Warfarin

University of Alberta

Vancouver Coastal Health Research Institute

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

Our primary outcome, percentage change in time spent OUTSIDE of therapeutic range is chosen because we believe this is a measure more likely to be shared by patients across a wide range of TTR (i.e. a patient with high baseline TTR and a patient with low baseline TTR may still share a similar % change in time outside of therapeutic range as a response to our intervention). This would not be true for change in TTR itself. It is also the time spent outside of range which contributes more directly to risk of thrombosis and hemorrhage and hence the change in this measure is more clinically meaningful than the change in TTR itself.

The percentage of patients with TTR > 75% provides the percentage of patients considered to have excellent control.

The percentage of patients with TTR < 60% provides the percentage of patients for whom other anticoagulation strategies may be indicated.

Includes all-cause mortality, hospitalization for stroke, hospitalization for GI bleeding, and deep venous thrombosis / pulmonary embolism.

For those patients with at least one INR value above the therapeutic range, the maximum INR observed.

For those patients with at least one INR value below the therapeutic range, the minimum INR value observed.

Includes non-hemorrhagic stroke, deep vein thrombosis, pulmonary embolus and acute arterial occlusion

Includes all bleeding events requiring hospitalization such as hemorrhagic stroke and GI bleeding

Patient self-reports of adherence to their allocated intervention during telephone follow-up occurring at 1 week, 1 month and upon study completion

Upon publication of all planned manuscripts stemming from this work, anonymized patient level trial data will be posted on www.PragmaticTrials.ca

pulmonary embolism/spinazie

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

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