Validation of International Warfarin Pharmacogenetics Consortium (IWPC) Algorithm in Elderly Patients With Comorbidity (VIALE)
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|ClinicalTrials.gov Identifier: NCT02069132|
Recruitment Status : Active, not recruiting
First Posted : February 21, 2014
Last Update Posted : April 27, 2017
|Condition or disease||Intervention/treatment|
|Atrial Fibrillation Thrombus Due to Heart Valve Prosthesis||Drug: Warfarin|
|Study Type :||Observational|
|Estimated Enrollment :||376 participants|
|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|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||June 2018|
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 treatment will be determined by treating physicians according to in-hospital guidelines, blindly to genotype assessment.
- Percentage of patients whose predicted dose of warfarin is within 20% of the actual stable therapeutic dose. [ Time Frame: 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.
- 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). [ Time Frame: up to 12 months ]
- number of cardiovascular and cerebrovascular events [ Time Frame: 12 months ]composite endpoint: death for any cause, hospitalization for cardiovascular and cerebrovascular events, major bleeding or thromboembolism
- number of patients with major bleeding events [ Time Frame: 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 [ Time Frame: 12 months ]thromboembolism is defined as occurrence of cerebral infarction, myocardial infarction, peripheral arterial embolism.
- number of cardiovascular and cerebrovascular events [ Time Frame: 4 weeks ]
- number of patient reported episodes of minor bleeding events [ Time Frame: one year ]
- average maintenance dose per patient [ Time Frame: 12 months ]
- time to achievement of stable warfarin dosing from initiation [ Time Frame: up to 12 months ]
- time to therapeutic INR per patient [ Time Frame: 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 time in the therapeutic INR range [ Time Frame: up to 3 months ]
- percentage time in the therapeutic INR range [ Time Frame: four weeks ]
Biospecimen Retention: Samples With DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02069132
|Second University of Naples|
|University of Naples Federico II|
|University of Salerno|
|Study Chair:||Ciro Gallo, MD||University of Campania "Luigi Vanvitelli"|
|Principal Investigator:||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|