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

NCT ID: NCT02069132

Last Updated: 2017-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

376 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2018-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation Thrombus Due to Heart Valve Prosthesis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Warfarin in elderly with comorbidity

Patients 65 years or older, candidate for therapy with warfarin for non valvular atrial fibrillation or heart valve replacement

Warfarin

Intervention Type DRUG

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

Interventions

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Warfarin

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federico II University

OTHER

Sponsor Role collaborator

University of Salerno

OTHER

Sponsor Role collaborator

University of Campania Luigi Vanvitelli

OTHER

Sponsor Role lead

Responsible Party

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Ciro Gallo

Professor of Medical Statistics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ciro Gallo, MD

Role: STUDY_CHAIR

University of Campania Luigi Vanvitelli

Amelia Filippelli, MD

Role: PRINCIPAL_INVESTIGATOR

University of Salerno

Marisa De Feo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Campania Luigi Vanvitelli

Nicola Ferrara, MD

Role: PRINCIPAL_INVESTIGATOR

Federico II University

Locations

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Second University of Naples

Napoli, , Italy

Site Status

University of Naples Federico II

Napoli, , Italy

Site Status

University of Salerno

Salerno, , Italy

Site Status

Countries

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Italy

Other Identifiers

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FARM9JNT9Y

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2012-002578-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VIALE

Identifier Type: -

Identifier Source: org_study_id

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