Clinical trial NCT02069132: Validation of International Warfarin Pharmacogenetics Consortium (IWPC) Algorithm in Elderly Patients With Comorbidity
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Thrombus Due to Heart Valve Prosthesis
Keywords: Warfarin
International Warfarin Pharmacogenetics Consortium algorithm
Atrial Fibrillation
Heart Valve Prosthesis Implantation
elderly
comorbidity
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
Collaborators: name: Federico II University
name: University of Salerno
First posted: 2014-02-21
Enrollment: 376
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: prospective cohort of elderly people (≥65 years) with nonvalvular atrial fibrillation and/or heart valve replacement, with at least one comorbid condition, presenting for warfarin therapy

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients whose predicted dose of warfarin is within 20% of the actual stable therapeutic dose.
timeFrame: up to 12 months
Secondary outcomes:
measure: 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).
timeFrame: up to 12 months
measure: number of cardiovascular and cerebrovascular events
timeFrame: 12 months
measure: number of patients with major bleeding events
timeFrame: 12 months
measure: number of thromboembolic event
timeFrame: 12 months
measure: number of cardiovascular and cerebrovascular events
timeFrame: 4 weeks
measure: number of patient reported episodes of minor bleeding events
timeFrame: one year
measure: average maintenance dose per patient
timeFrame: 12 months
measure: time to achievement of stable warfarin dosing from initiation
timeFrame: up to 12 months
measure: time to therapeutic INR per patient
timeFrame: up to 12 months
measure: percentage time in the therapeutic INR range
timeFrame: up to 3 months
measure: percentage time in the therapeutic INR range
timeFrame: four weeks
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Second University of Naples
city: Napoli
country: Italy
facility: University of Naples Federico II
city: Salerno
country: Italy
facility: University of Salerno
Study officials:
affiliation: University of Campania Luigi Vanvitelli
name: Ciro Gallo, MD
role: STUDY_CHAIR
affiliation: University of Salerno
name: Amelia Filippelli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Campania Luigi Vanvitelli
name: Marisa De Feo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federico II University
name: Nicola Ferrara, MD
role: PRINCIPAL_INVESTIGATOR
References: