Changes in Oral Vitamin K Intake for Optimization of Chronic Oral Anticoagulation: A Randomized Trial

Hospital de Clinicas de Porto Alegre114 enrolled

Overview

The primary hypothesis of this trial is that changes in oral vitamin K intake, based on simple food registries, may be superior to conventional changes in doses of medications in order to stabilize chronic oral anticoagulation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

114

Conditions

Blood Coagulation Disorders

Interventions

Changes on Oral Vitamin K IntakeBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with any clinical indication for chronic oral anticoagulation with one INR level out of target, without a clear clinical cause for INR instability (unplanned changes in coumadin medications, other pharmacological interactions, clinical illnesses and laboratory errors). Exclusion Criteria: * Clinical evidence of bleeding or thrombosis. * INR \> 4 or INR \< 1,5.

Locations (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Outcomes

Primary Outcomes

Percentage of patients on target International Normalized Ratio (prothrombin time) on day 90th after randomization

Stabilization of International Normalized Ratio (prothrombin time) during follow-up (90 days after randomization)

Data from ClinicalTrials.gov

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