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

• Conditions: Atrial Fibrillation; Thrombus Due to Heart Valve Prosthesis
• Interventions: Drug: Warfarin

• Registration Number: NCT02069132
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2014-02-20
• Study First Submitted QC: 2014-02-20
• Study First Posted: 2014-02-21
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-26
• Last Update Posted: 2017-04-27
• Primary Completion: 2017-12
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 376

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Warfarin in elderly with comorbidity	Warfarin	Patients 65 years or older, candidate for therapy with warfarin for non valvular atrial fibrillation or heart valve replacement

Primary Outcome Measures

Name	Time	Method
Percentage of patients whose predicted dose of warfarin is within 20% of the actual stable therapeutic dose.	up to 12 months	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

Name	Time	Method
number of patient reported episodes of minor bleeding events	one year
number of cardiovascular and cerebrovascular events	4 weeks
number of patients with major bleeding events	12 months	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	12 months	thromboembolism is defined as occurrence of cerebral infarction, myocardial infarction, peripheral arterial embolism.
average maintenance dose per patient	12 months
time to therapeutic INR per patient	up to 12 months	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 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
time to achievement of stable warfarin dosing from initiation	up to 12 months
percentage time in the therapeutic INR range	four weeks

Trial Locations

Locations (3)

Second University of Naples; 🇮🇹 Napoli, Italy

University of Naples Federico II; 🇮🇹 Napoli, Italy

University of Salerno; 🇮🇹 Salerno, Italy