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

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ClinicalTrials.gov Identifier: NCT02069132
Recruitment Status : Active, not recruiting
First Posted : February 21, 2014
Last Update Posted : April 27, 2017
Sponsor:
Collaborators:
Federico II University
University of Salerno
Information provided by (Responsible Party):
Ciro Gallo, Second University of Naples

Brief Summary:
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.

Condition or disease Intervention/treatment
Atrial Fibrillation Thrombus Due to Heart Valve Prosthesis Drug: Warfarin

Study Type : Observational
Estimated Enrollment : 376 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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 Start Date : March 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Warfarin in elderly with comorbidity
Patients 65 years or older, candidate for therapy with warfarin for non valvular atrial fibrillation or heart valve replacement
Drug: Warfarin
warfarin treatment will be determined by treating physicians according to in-hospital guidelines, blindly to genotype assessment.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
  2. 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

  3. 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.

  4. number of thromboembolic event [ Time Frame: 12 months ]
    thromboembolism is defined as occurrence of cerebral infarction, myocardial infarction, peripheral arterial embolism.

  5. number of cardiovascular and cerebrovascular events [ Time Frame: 4 weeks ]
  6. number of patient reported episodes of minor bleeding events [ Time Frame: one year ]
  7. average maintenance dose per patient [ Time Frame: 12 months ]
  8. time to achievement of stable warfarin dosing from initiation [ Time Frame: up to 12 months ]
  9. 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

  10. percentage time in the therapeutic INR range [ Time Frame: up to 3 months ]
  11. percentage time in the therapeutic INR range [ Time Frame: four weeks ]

Biospecimen Retention:   Samples With DNA
Whole blood


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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
prospective cohort of elderly people (≥65 years) with nonvalvular atrial fibrillation and/or heart valve replacement, with at least one comorbid condition, presenting for warfarin therapy
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02069132


Locations
Italy
Second University of Naples
Napoli, Italy
University of Naples Federico II
Napoli, Italy
University of Salerno
Salerno, Italy
Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"
Federico II University
University of Salerno
Investigators
Study Chair: Ciro Gallo, MD University of Campania "Luigi Vanvitelli"
Principal Investigator: Amelia Filippelli, MD University of Salerno
Principal Investigator: Marisa De Feo, MD University of Campania "Luigi Vanvitelli"
Principal Investigator: Nicola Ferrara, MD Federico II University

Responsible Party: Ciro Gallo, Professor of Medical Statistics, Second University of Naples
ClinicalTrials.gov Identifier: NCT02069132     History of Changes
Other Study ID Numbers: VIALE
FARM9JNT9Y ( Other Grant/Funding Number: Agenzia Italiana per il Farmaco (AIFA) )
2012-002578-30 ( EudraCT Number )
First Posted: February 21, 2014    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017

Keywords provided by Ciro Gallo, Second University of Naples:
Warfarin
International Warfarin Pharmacogenetics Consortium algorithm
Atrial Fibrillation
Heart Valve Prosthesis Implantation
elderly
comorbidity

Additional relevant MeSH terms:
Atrial Fibrillation
Thrombosis
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Warfarin
Anticoagulants