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

Information source: Second University of Naples
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Atrial Fibrillation; Thrombus Due to Heart Valve Prosthesis

Intervention: Warfarin (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Second University of Naples

Official(s) and/or principal investigator(s):
Ciro Gallo, MD, Study Chair, Affiliation: Second University of Naples
Amelia Filippelli, MD, Principal Investigator, Affiliation: University of Salerno
Marisa De Feo, MD, Principal Investigator, Affiliation: Second University of Naples
Nicola Ferrara, MD, Principal Investigator, Affiliation: Federico II University

Overall contact:
Ciro Gallo, MD, Phone: +39 0815666021, Email: ciro.gallo@unina2.it

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.

Clinical Details

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 design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Percentage of patients whose predicted dose of warfarin is within 20% of the actual stable therapeutic dose.

Secondary outcome:

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).

number of cardiovascular and cerebrovascular events

number of patients with major bleeding events

number of thromboembolic event

number of cardiovascular and cerebrovascular events

number of patient reported episodes of minor bleeding events

average maintenance dose per patient

time to achievement of stable warfarin dosing from initiation

time to therapeutic INR per patient

percentage time in the therapeutic INR range

percentage time in the therapeutic INR range

Eligibility

Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Ciro Gallo, MD, Phone: +39 0815666021, Email: ciro.gallo@unina2.it

Second University of Naples, Napoli, Italy; Recruiting

University of Naples Federico II, Napoli, Italy; Recruiting

University of Salerno, Salerno, Italy; Recruiting

Additional Information

Starting date: March 2013
Last updated: November 25, 2014

Page last updated: August 23, 2015

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