NCT02069132

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
376

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 21, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

April 27, 2017

Status Verified

April 1, 2017

Enrollment Period

4.8 years

First QC Date

February 20, 2014

Last Update Submit

April 26, 2017

Conditions

Atrial FibrillationThrombus Due to Heart Valve Prosthesis

Keywords

WarfarinInternational Warfarin Pharmacogenetics Consortium algorithmAtrial FibrillationHeart Valve Prosthesis Implantationelderlycomorbidity

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients whose predicted dose of warfarin is within 20% of the actual stable therapeutic dose.

    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.

    up to 12 months

Secondary Outcomes (11)

  • 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).

    up to 12 months

  • number of cardiovascular and cerebrovascular events

    12 months

  • number of patients with major bleeding events

    12 months

  • number of thromboembolic event

    12 months

  • number of cardiovascular and cerebrovascular events

    4 weeks

  • +6 more secondary outcomes

Study Arms (1)

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

Interventions

WarfarinDRUG

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

Warfarin in elderly with comorbidity

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Second University of Naples

Napoli, Italy

Location

University of Naples Federico II

Napoli, Italy

Location

University of Salerno

Salerno, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Warfarin

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Ciro Gallo, MD

    University of Campania Luigi Vanvitelli

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medical Statistics

Study Record Dates

First Submitted

February 20, 2014

First Posted

February 21, 2014

Study Start

March 1, 2013

Primary Completion

December 1, 2017

Study Completion

June 1, 2018

Last Updated

April 27, 2017

Record last verified: 2017-04

Locations

IT(3)