Pharmacogenetic Dosage Algorithm for Acenocoumarol

NCT03015025 | Completed

• 1 other identifier: FC/HULP_005/2011
• Study Type: observational
• Target: 340
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation; Venous Thromboses; Cardiac Valve Disease

Keywords

Acenocoumarol; Cytochrome P450; Pharmacogenetics; Algorithm; CYP2C9; VKORC1; CYP4F2; P450 oxidoreductase (POR)

Outcome Measures

Primary Outcomes (1)

• Creation of a pharmacogenetic algorithm of dosage for acenocoumarol

  Up to 5 years

Secondary Outcomes (1)

• Validation of the pharmacogenetic algorithm.

  Up to 5 years

Study Arms (1)

Stable treatment with acenocoumarol

Patients in stable anticoagulant treatment with acenocoumarol for auricular fibrillation, venous thromboembolic disease and/or cardiac valve replacement.

Genetic: Acenocoumarol

Interventions

Acenocoumarol GENETIC

A blood sample was collected for CYP2C9, VKORC1, CYP4F2, APOE and 2 variants of POR genotypes.

Stable treatment with acenocoumarol

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving stable anticoagulant treatment with acenocoumarol for auricular fibrillation, venous thromboembolic disease and/or cardiac valve replacement in Hospital La Paz and Barrio del Pilar primary care center.

You may qualify if:

• 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.

You may not qualify if:

• Patients with renal failure (calculated creatinine clearance ≤30 ml/min), hepatic disease (stage C of Child Plough Stage), thyroid dysfunction and/or cancer.

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead

Study Sites (1)

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Patients' consent was requested for the preservation of their DNA sample, in case of new genes related to the pharmacokinetics or pharmacodynamics of acenocoumarol are discovered in the future.

MeSH Terms

Conditions

Atrial Fibrillation; Venous Thrombosis; Heart Valve Diseases; Vitamin K-Dependent Clotting Factors, Combined Deficiency Of, Type 2

Interventions

Acenocoumarol

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Thrombosis; Embolism and Thrombosis; Vascular Diseases

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Antonio Carcas, MD, PhD

  Hospital Universitario La Paz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2017
• First Posted: January 9, 2017
• Study Start: October 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: January 9, 2017

Record last verified: 2011-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)