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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Second University of Naples
Sponsor:
Collaborators:
Federico II University
University of Salerno
Information provided by (Responsible Party):
Ciro Gallo, Second University of Naples
ClinicalTrials.gov Identifier:
NCT02069132
First received: February 20, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose

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 Intervention
Atrial Fibrillation
Thrombus Due to Heart Valve Prosthesis
Drug: Warfarin

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Second University of Naples:

Primary Outcome Measures:
  • Percentage of patients whose predicted dose of warfarin is within 20% of the actual stable therapeutic dose. [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
  • number of cardiovascular and cerebrovascular events [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    thromboembolism is defined as occurrence of cerebral infarction, myocardial infarction, peripheral arterial embolism.

  • number of cardiovascular and cerebrovascular events [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • number of patient reported episodes of minor bleeding events [ Time Frame: one year ] [ Designated as safety issue: No ]
  • average maintenance dose per patient [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • time to achievement of stable warfarin dosing from initiation [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • time to therapeutic INR per patient [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • percentage time in the therapeutic INR range [ Time Frame: four weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood


Estimated Enrollment: 1100
Study Start Date: March 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02069132

Contacts
Contact: Ciro Gallo, MD +39 0815666021 ciro.gallo@unina2.it
Contact: Simona Signoriello, Ph.D. +39 0815666021 simona.signoriello@unina2.it

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

No publications provided

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, 2012-002578-30
Study First Received: February 20, 2014
Last Updated: February 20, 2014
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Warfarin
Atrial Fibrillation
Thrombosis
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014