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

University of Campania "Luigi Vanvitelli"

Status: Unknown

Conditions: Thrombus Due to Heart Valve Prosthesis; Atrial Fibrillation

Treatments: Drug: Warfarin

Study type: Observational

Funder types: Other

Identifiers

NCT02069132

2012-002578-30 (EudraCT Number)

FARM9JNT9Y (Other Grant/Funding Number)

VIALE

Details and patient eligibility

About

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.

Enrollment: 376 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

376 participants in 1 patient group

Warfarin in elderly with comorbidity

Description:

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

Treatment:

Drug: Warfarin