Atrial FibrillationVIALENCT02069132
Validation of International Warfarin Pharmacogenetics Consortium (IWPC) Algorithm in Elderly Patients With Comorbidity
An observational study of Atrial Fibrillation and Thrombus Due to Heart Valve Prosthesis, run by University of Campania Luigi Vanvitelli at 3 sites in Italy.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Atrial Fibrillation, Thrombus Due to Heart Valve Prosthesis
- What is being tested?
- Warfarin
- How many people
- 376 participants
- Where
- 3 sitesItaly
- Study dates
- Mar 2013to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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
Who may be able to join
- 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
Who cannot join
- Presence of systemic coagulopathies
- Presence of malignancies needing chemotherapy
- Inability or refusal to give informed consent
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Second University of Naples
Naples
University of Naples Federico II
Naples
University of Salerno
Salerno
About this study
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
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.
- Being tested
- Warfarin
- Keywords
- Warfarin, International Warfarin Pharmacogenetics Consortium algorithm, Atrial Fibrillation, Heart Valve Prosthesis Implantation, elderly, comorbidity
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WarfarinDrug
warfarin treatment will be determined by treating physicians according to in-hospital guidelines, blindly to genotype assessment.
| Study group | Role | What they receive |
|---|---|---|
| Warfarin in elderly with comorbidity | Patients 65 years or older, candidate for therapy with warfarin for non valvular atrial fibrillation or heart valve replacement Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 12 months
Secondary outcomes (11)
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).
Measured: up to 12 months
number of cardiovascular and cerebrovascular events
composite endpoint: death for any cause, hospitalization for cardiovascular and cerebrovascular events, major bleeding or thromboembolism
Measured: 12 months
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.
Measured: 12 months
number of thromboembolic event
thromboembolism is defined as occurrence of cerebral infarction, myocardial infarction, peripheral arterial embolism.
Measured: 12 months
number of cardiovascular and cerebrovascular events
Measured: 4 weeks
number of patient reported episodes of minor bleeding events
Measured: one year
average maintenance dose per patient
Measured: 12 months
time to achievement of stable warfarin dosing from initiation
Measured: up to 12 months
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
Measured: up to 12 months
percentage time in the therapeutic INR range
Measured: up to 3 months
percentage time in the therapeutic INR range
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startMar 2013
- Primary completionDec 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 376 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Collaborators
- Federico II University, University of Salerno
- Responsible party
- Principal investigator, Ciro Gallo, University of Campania Luigi Vanvitelli
- Investigators
- Ciro Gallo, MD, Study chair, University of Campania Luigi VanvitelliAmelia Filippelli, MD, Principal investigator, University of SalernoMarisa De Feo, MD, Principal investigator, University of Campania Luigi VanvitelliNicola Ferrara, MD, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069132
- Sponsor's protocol ID
- VIALE
- Other IDs
- FARM9JNT9Y, 2012-002578-30
- Acronym
- VIALE
- Status last verified
- Apr 2017
- First submitted
- 20 Feb 2014
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02069132
- Acronym / sponsor ID
- VIALE / VIALE
- Keywords
- Warfarin, International Warfarin Pharmacogenetics Consortium algorithm, Atrial Fibrillation, Heart Valve Prosthesis Implantation, elderly, comorbidity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 376 participants (estimated)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Collaborators
- Federico II University, University of Salerno
- Study start
- Mar 2013
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 21 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Warfarin in elderly with comorbidity | – | Drug: WarfarinPatients 65 years or older, candidate for therapy with warfarin for non valvular atrial fibrillation or heart valve replacement |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Presence of systemic coagulopathies
- Presence of malignancies needing chemotherapy
- Inability or refusal to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Warfarinwarfarin treatment will be determined by treating physicians according to in-hospital guidelines, blindly to genotype assessment. | Drug | Warfarin in elderly with comorbidity |
Primary outcome
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.
11 secondary outcomes
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
number of patients with major bleeding events
Time frame: 12 months
number of thromboembolic event
Time frame: 12 months
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
percentage time in the therapeutic INR range
Time frame: up to 3 months
percentage time in the therapeutic INR range
Time frame: four weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ciro Gallo, MD study chair
University of Campania Luigi Vanvitelli
Amelia Filippelli, MD principal investigator
University of Salerno
Marisa De Feo, MD principal investigator
University of Campania Luigi Vanvitelli
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Thrombus Due to Heart Valve Prosthesis, run by University of Campania Luigi Vanvitelli at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients whose predicted dose of warfarin is within 20% of the actual stable therapeutic dose. (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017.