Auricular FibrillationNCT04133545
Discontinuation for Oral Anticoagulants in Patients With Atrial Fibrillation
An observational study of Auricular Fibrillation and Anticoagulant Drugs, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial summary
The purpose of this study is to compare the discontinuation rates for vitamin K antagonists and for direct oral anticoagulants during their first year Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Auricular Fibrillation, Anticoagulant Drugs
- Type of treatment
- Pill or oral medicine
- How many people
- 360 participants
- Where
- 1 siteArgentina
- Study dates
- 4 Apr 2018to Sep 2020
- 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: Patients belonging to a Health Management Organization suffering from atrial fibrillation
Who may be able to join
- Patient older than 18 years of age covered by our Health Care Insurance Plan.
- Indication for oral anticoagulation with an expected duration of use of no less than 1 year.
Who cannot join
- Refusal to take part.
- Use of oral anticoagulants within 6 months prior to admission.
- Presence of mechanical prosthetic valve.
- Chronic renal failure with creatinine clearance <30 mL/min (estimated using the MDRD formula).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Discontinuation for Oral Anticoagulants During the First Year of Use in Patients With Atrial Fibrillation Covered by a Medical Insurance
The purpose of this study is to compare the discontinuation rates for vitamin K antagonists and for direct oral anticoagulants during their first year
Read the detailed description
The purpose of this study is to compare the discontinuation rates for vitamin K antagonists and for direct oral anticoagulants during their first year of use after their initiation during hospitalization in patients covered by our health insurance plan.
- Conditions
- Auricular Fibrillation, Anticoagulant Drugs
- Medical subject headings
- 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 |
|---|---|---|
| DOAC | Direct oral anticoagulant | |
| OAC | Vitamin K anticoagulant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anticoagulant Discontinuation Rate
Anticoagulant Discontinuation Rate
Measured: One year
Secondary outcomes (1)
Discontinuation Predictors
Discontinuation Predictors
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start4 Apr 2018
- Primary completion30 Sep 2019
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auricular 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
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Principal investigator, JOSE LUIS CARLOS NAVARRO, Hospital Italiano de Buenos Aires
- Investigators
- Jose L Navarrro Estrada, MD, Principal investigator, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133545
- Sponsor's protocol ID
- Protocol_3525
- Status last verified
- Oct 2019
- First submitted
- 17 Oct 2019
- Last updated
- 21 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discontinuation for Oral Anticoagulants During the First Year of Use in Patients With Atrial Fibrillation Covered by a Medical Insurance
- ClinicalTrials.gov ID
- NCT04133545
- Acronym / sponsor ID
- Protocol_3525
- Conditions
- Auricular Fibrillation, Anticoagulant Drugs
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- Sep 2020 (estimated)
- First posted
- 21 Oct 2019 (actual)
- 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 compare the discontinuation rates for vitamin K antagonists and for direct oral anticoagulants during their first year
Detailed description
The purpose of this study is to compare the discontinuation rates for vitamin K antagonists and for direct oral anticoagulants during their first year of use after their initiation during hospitalization in patients covered by our health insurance plan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DOAC | – | –Direct oral anticoagulant |
| OAC | – | –Vitamin K anticoagulant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients belonging to a Health Management Organization suffering from atrial fibrillation
Key inclusion criteria (2 listed)
- Patient older than 18 years of age covered by our Health Care Insurance Plan.
- Indication for oral anticoagulation with an expected duration of use of no less than 1 year.
Key exclusion criteria (4 listed)
- Refusal to take part.
- Use of oral anticoagulants within 6 months prior to admission.
- Presence of mechanical prosthetic valve.
- Chronic renal failure with creatinine clearance <30 mL/min (estimated using the MDRD formula).
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
Anticoagulant Discontinuation Rate
Time frame: One year
Anticoagulant Discontinuation Rate
1 secondary outcome
Discontinuation Predictors
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- Individual participant dataSharing planned: No
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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.
Jose L Navarrro Estrada, MD principal investigator
Hospital Italiano de Buenos Aires
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Auricular Fibrillation and Anticoagulant Drugs, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
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 2 inclusion and 4 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 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. 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?
Anticoagulant Discontinuation Rate (time frame: One year). 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 21 Oct 2019.