Non-Valvular Atrial FibrillationNCT02756481
Local Adaptation of Cost Effectiveness Model for Apixaban Atrial Fibrillation Indication - Venezuela
An observational study of Non-Valvular Atrial Fibrillation, run by Bristol-Myers Squibb.
Trial summary
To characterize treatment patterns and healthcare resource utilization among adults diagnosed with non-valvular atrial fibrillation (NVAF) from the private setting in Venezuela. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Valvular Atrial Fibrillation
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Nov 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This observational, non-interventional, retrospective and longitudinal study of NVAF patients in the private sector in Venezuela based on two study samples to be analyzed separately, medical chart review and an electronic database analysis
Who may be able to join
- Patients with diagnosis of AF (incident and prevalent cases)
- Patient with at least 18 years
- Patients enrolment before and during the study period
- Patients treated in Venezuela
Who cannot join
- Women who were pregnant at any moment during the study period
About this study
Official title: Treatment Patterns of Care for Patients With Atrial Fibrillation In Venezuela
To characterize treatment patterns and healthcare resource utilization among adults diagnosed with non-valvular atrial fibrillation (NVAF) from the private setting in Venezuela.
- Conditions
- Non-Valvular Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NVAF Treatment patterns | Treatment patterns will be collected during the follow-up period. Data will be directly extracted from medical charts of the arrhythmia unit. Anticoagulation use will be reported as drug class: Vitamin K antagonist, antiplatelet, nonsteroidal anti-inflammatory drugs. The following data on anticoagulation use will be collected: * Type of treatment, start \& stop dates, dosage, administration schedule, method of administration, reason for discontinuation if applicable * Type of therapy utilized (monotherapy/combination therapy) * Total number of therapy changes or switches through the course of treatment * Monitoring visit (visits per month) for International normalized ratio (INR) control by Time in Therapeutic Range(cTTR) * Routine care (visits per month) by anticoagulation regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Hospitalization
Measured: approximately 2 years after enrollment
Duration of Hospitalization
Measured: approximately 2 years after enrollment
Frequency of Outpatient visits
Measured: approximately 2 years after enrollment
Secondary outcomes (16)
Incidence of Cerebrovascular Disease (CVD)
Measured: Up to 3 years
Frequency of Hospitalization due to Cerebrovascular Disease (CVD)
Measured: Up to 3 years
Duration of Hospitalization due to Cerebrovascular Disease (CVD)
Measured: Up to 3 years
Frequency of Outpatient Visits due to Cerebrovascular Disease (CVD)
Measured: Up to 3 years
Incidence of Acute Myocardial Infarction (AMI)
Measured: Up to 3 years
Frequency of Hospitalization due to Acute Myocardial Infarction (AMI)
Measured: Up to 3 years
Duration of Hospitalization due to Acute Myocardial Infarction (AMI)
Measured: Up to 3 years
Frequency of Outpatient Visits due to Acute Myocardial Infarction (AMI)
Measured: Up to 3 years
Incidence of Systemic Embolism (SE)
Measured: Up to 3 years
Frequency of Hospitalization due to Systemic Embolism (SE)
Measured: Up to 3 years
Duration of Hospitalization due to Systemic Embolism (SE)
Measured: Up to 3 years
Frequency of Outpatient Visits due to Systemic Embolism (SE)
Measured: Up to 3 years
Incidence of Gastrointestinal Hemorrhage (GIH)
Measured: Up to 3 years
Frequency of Hospitalization due to Gastrointestinal Hemorrhage (GIH)
Measured: Up to 3 years
Duration of Hospitalization due to Gastrointestinal Hemorrhage (GIH)
Measured: Up to 3 years
Frequency of Outpatient Visits due to Gastrointestinal Hemorrhage (GIH)
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startOct 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Valvular Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756481
- Sponsor's protocol ID
- CV185-333
- Status last verified
- Apr 2016
- First submitted
- 9 Oct 2015
- Last updated
- 29 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Patterns of Care for Patients With Atrial Fibrillation In Venezuela
- ClinicalTrials.gov ID
- NCT02756481
- Acronym / sponsor ID
- CV185-333
- Conditions
- Non-Valvular Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 29 Apr 2016 (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.
To characterize treatment patterns and healthcare resource utilization among adults diagnosed with non-valvular atrial fibrillation (NVAF) from the private setting in Venezuela.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NVAF Treatment patterns | – | –Treatment patterns will be collected during the follow-up period. Data will be directly extracted from medical charts of the arrhythmia unit. Anticoagulation use will be reported as drug class: Vitamin K antagonist, antiplatelet, nonsteroidal anti-inflammatory drugs. The following data on anticoagulation use will be collected: * Type of treatment, start \& stop dates, dosage, administration schedule, method of administration, reason for discontinuation if applicable * Type of therapy utilized (monotherapy/combination therapy) * Total number of therapy changes or switches through the course of treatment * Monitoring visit (visits per month) for International normalized ratio (INR) control by Time in Therapeutic Range(cTTR) * Routine care (visits per month) by anticoagulation regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This observational, non-interventional, retrospective and longitudinal study of NVAF patients in the private sector in Venezuela based on two study samples to be analyzed separately, medical chart review and an electronic database analysis
Key inclusion criteria (4 listed)
- Patients with diagnosis of AF (incident and prevalent cases)
- Patient with at least 18 years
- Patients enrolment before and during the study period
- Patients treated in Venezuela
Key exclusion criteria (1 listed)
- Women who were pregnant at any moment during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of Hospitalization
Time frame: approximately 2 years after enrollment
Duration of Hospitalization
Time frame: approximately 2 years after enrollment
Frequency of Outpatient visits
Time frame: approximately 2 years after enrollment
16 secondary outcomes
Incidence of Cerebrovascular Disease (CVD)
Time frame: Up to 3 years
Frequency of Hospitalization due to Cerebrovascular Disease (CVD)
Time frame: Up to 3 years
Duration of Hospitalization due to Cerebrovascular Disease (CVD)
Time frame: Up to 3 years
Frequency of Outpatient Visits due to Cerebrovascular Disease (CVD)
Time frame: Up to 3 years
Incidence of Acute Myocardial Infarction (AMI)
Time frame: Up to 3 years
Frequency of Hospitalization due to Acute Myocardial Infarction (AMI)
Time frame: Up to 3 years
Duration of Hospitalization due to Acute Myocardial Infarction (AMI)
Time frame: Up to 3 years
Frequency of Outpatient Visits due to Acute Myocardial Infarction (AMI)
Time frame: Up to 3 years
Incidence of Systemic Embolism (SE)
Time frame: Up to 3 years
Frequency of Hospitalization due to Systemic Embolism (SE)
Time frame: Up to 3 years
Duration of Hospitalization due to Systemic Embolism (SE)
Time frame: Up to 3 years
Frequency of Outpatient Visits due to Systemic Embolism (SE)
Time frame: Up to 3 years
Incidence of Gastrointestinal Hemorrhage (GIH)
Time frame: Up to 3 years
Frequency of Hospitalization due to Gastrointestinal Hemorrhage (GIH)
Time frame: Up to 3 years
Duration of Hospitalization due to Gastrointestinal Hemorrhage (GIH)
Time frame: Up to 3 years
Frequency of Outpatient Visits due to Gastrointestinal Hemorrhage (GIH)
Time frame: Up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2016.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Valvular Atrial Fibrillation, run by Bristol-Myers Squibb.
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 1 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: finished, as of the sponsor's last update on 29 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency of Hospitalization (time frame: approximately 2 years after enrollment). The study lists 3 primary outcomes in all. 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 29 Apr 2016.