CompletedNot Applicable

Pharmacogenetic Dosage Algorithm for Acenocoumarol

Spain340 participantsStarted 2011-10

Plain-language summary

The use of coumarins has been a challenge for doctors because of its narrow therapeutic range and they show great inter and intra-individual variability in the dose necessary to achieve an international normalized ratio (INR) within the therapeutic range. Among the factors influencing the interindividual variability in the dose required include age, weight, Vitamin K in the diet, comorbidity as well as drug interactions and in recent years has also seen the importance of pharmacogenetic factors.

Who can participate

Age range18 Years – 99 Years

SexALL

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Inclusion Criteria: * Patients with Auricular fibrillation, venous thromboembolic disease and cardiac valve replacement receiving acenocoumarol. * Patients with stable dose of acenocoumarol (weekly dose variation of \<20% in the last 3 months). * Patients with an international normalised ratio within the range of 2 to 3 (in Auricular Fibrillation and venous thromboembolic disease) or 2.5 to 3.5 (in cardiac valve replacement) for at least the 3 previous consecutive months. Exclusion Criteria: * Patients with renal failure (calculated creatinine clearance ≤30 ml/min), hepatic disease (stage C of Child Plough Stage), thyroid dysfunction and/or cancer.

What they're measuring

Creation of a pharmacogenetic algorithm of dosage for acenocoumarol

Timeframe: Up to 5 years

Trial details

NCT IDNCT03015025

SponsorInstituto de Investigación Hospital Universitario La Paz

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2013-10

View on ClinicalTrials.gov More Atrial Fibrillation trials