Validation of International Warfarin Pharmacogenetics Consortium (IWPC) Algorithm in Elderly Patients With Comorbidity

Overview

The purpose of this study is to validate the International Warfarin Pharmacogenetics Consortium (IWPC) algorithm in a prospective cohort of elderly people (65 years or older) with heart valves and/or nonvalvular atrial fibrillation (AF) and at least one comorbid condition, and to assess the algorithm's prognostic relevance.

Full Title of Study: “Prospective Validation of IWPC Pharmacogenetic Algorithm for Estimating the Appropriate Initial Dose of Warfarin in Elderly People (65 or Older) With Heart Valves Prostheses or Non Valvular Atrial Fibrillation and Comorbidity”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2017

Interventions

  • Drug: Warfarin
    • warfarin treatment will be determined by treating physicians according to in-hospital guidelines, blindly to genotype assessment.

Arms, Groups and Cohorts

  • Warfarin in elderly with comorbidity
    • Patients 65 years or older, candidate for therapy with warfarin for non valvular atrial fibrillation or heart valve replacement

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of patients whose predicted dose of warfarin is within 20% of the actual stable therapeutic dose.
    • Time Frame: up to 12 months
    • stable warfarin dosing is defined as the mean daily does required to achieve three or more consecutive International Normalized Ratio (INR) measurements within the individual’s target range, at the same daily does.

Secondary Measures

  • Percentage of patients for whom the predicted dose is at least 20% higher than the actual dose (overestimation) or at least 20% lower than the actual dose (underestimation).
    • Time Frame: up to 12 months
  • number of cardiovascular and cerebrovascular events
    • Time Frame: 12 months
    • composite endpoint: death for any cause, hospitalization for cardiovascular and cerebrovascular events, major bleeding or thromboembolism
  • number of patients with major bleeding events
    • Time Frame: 12 months
    • major bleeding: (i) fatal bleeding; and/or (ii) symptomatic bleeding in a critical area or organ; and/or (iii) bleeding causing a fall in haemoglobin level of ≥2 g/dL or leading to transfusion of two or more units of blood or red cells.
  • number of thromboembolic event
    • Time Frame: 12 months
    • thromboembolism is defined as occurrence of cerebral infarction, myocardial infarction, peripheral arterial embolism.
  • number of cardiovascular and cerebrovascular events
    • Time Frame: 4 weeks
  • number of patient reported episodes of minor bleeding events
    • Time Frame: one year
  • average maintenance dose per patient
    • Time Frame: 12 months
  • time to achievement of stable warfarin dosing from initiation
    • Time Frame: up to 12 months
  • time to therapeutic INR per patient
    • Time Frame: up to 12 months
    • defined as the time of first achieving INR measurement within the individual’s target range, providing that INR is also within the target range at the subsequent clinic visit
  • percentage time in the therapeutic INR range
    • Time Frame: up to 3 months
  • percentage time in the therapeutic INR range
    • Time Frame: four weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Age ≥ 65 years – Patients who initiate warfarin because of non valvular atrial fibrillation or heart valve replacement – At least one comorbid condition – At least two other drugs regularly assumed over and above warfarin Exclusion Criteria:

  • Presence of systemic coagulopathies – Presence of malignancies needing chemotherapy – Inability or refusal to give informed consent

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Campania “Luigi Vanvitelli”
  • Collaborator
    • Federico II University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ciro Gallo, Professor of Medical Statistics – University of Campania “Luigi Vanvitelli”
  • Overall Official(s)
    • Ciro Gallo, MD, Study Chair, University of Campania “Luigi Vanvitelli”
    • Amelia Filippelli, MD, Principal Investigator, University of Salerno
    • Marisa De Feo, MD, Principal Investigator, University of Campania “Luigi Vanvitelli”
    • Nicola Ferrara, MD, Principal Investigator, Federico II University

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