Official Title: “Changes in Oral Vitamin K Intake for Optimization of Chronic Oral Anticoagulation: A Randomized Trial”

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

Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Behavioral: Changes on Oral Vitamin K Intake

Primary Measures

• 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)

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Hospital de Clinicas de Porto Alegre

Overall Clinical Trial Officials and Contacts

Luis E Rohde, MD Principal Investigator Universidade Federal do Rio Grande do Sul  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00355290

Study ID Number: HCPA2006.01

ClinicalTrials.gov Identifier: NCT00355290

Health Authority: Brazil: Ministry of Health