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

Atrial Fibrillation Clinical Trial

— VIALE  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02069132
• Other study ID #: VIALE
• Secondary ID: FARM9JNT9Y2012-0
• Status: Active, not recruiting
• Phase: N/A
• First received: February 20, 2014
• Last updated: April 26, 2017
• Start date: March 2013
• Est. completion date: June 2018

Study information

• Verified date: April 2017
• Source: Second University of Naples
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 376
• Est. completion date: June 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Thrombosis
• Thrombus Due to Heart Valve Prosthesis

Intervention

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

Locations

Country	Name	City	State
Italy	Second University of Naples	Napoli
Italy	University of Naples Federico II	Napoli
Italy	University of Salerno	Salerno

Sponsors (3)

Lead Sponsor	Collaborator
Second University of Naples	Federico II University, University of Salerno

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	number of cardiovascular and cerebrovascular events	composite endpoint: death for any cause, hospitalization for cardiovascular and cerebrovascular events, major bleeding or thromboembolism	12 months
Secondary	number of patients with major bleeding events	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.	12 months
Secondary	number of thromboembolic event	thromboembolism is defined as occurrence of cerebral infarction, myocardial infarction, peripheral arterial embolism.	12 months
Secondary	number of cardiovascular and cerebrovascular events		4 weeks
Secondary	number of patient reported episodes of minor bleeding events		one year
Secondary	average maintenance dose per patient		12 months
Secondary	time to achievement of stable warfarin dosing from initiation		up to 12 months
Secondary	time to therapeutic INR per patient	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	up to 12 months
Secondary	percentage time in the therapeutic INR range		up to 3 months
Secondary	percentage time in the therapeutic INR range		four weeks