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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Behavioral: Changes on Oral Vitamin K Intake
Outcome Measures for this Clinical Trial
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)
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Hospital de Clinicas de Porto Alegre Other
Overall Clinical Trial Officials and Contacts
Luis E Rohde, MD Principal Investigator Federal University of Rio Grande do Sul
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00355290
