AnticoagulationEWANCT02761941
Excessive Warfarin Anticoagulation - Causes and Consequences
An observational study of Anticoagulation, run by University of Turku at 1 site in Finland.
Trial summary
The aim of this study is to investigate the clinical significance of high INR (International Normalized Ratio) values (>9) in VKA (vitamin K antagonist) treated patients with atrial fibrillation. The clinical characteristics of these patients will be studied as well as the clinical presentation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anticoagulation
- How many people
- 25,000 participants
- Where
- 1 siteFinland
- Study dates
- May 2016to Dec 2019
- How long will I take part?
- 90 Days
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated with VKA for atrial fibrillation in the Southwest Finland hospital district area with INR value over 9.
Who may be able to join
- VKA treatment, age > 18, INR >9,
Who cannot join
- age < 18
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Turku University Hospital
Turku
Juhani Airaksinen, prof, +35823131005, juhani.airaksinen@tyks.fi
Tuomas Kiviniemi, MD, PhD, +35823130787, tuoski@utu.fi
About this study
The aim of this study is to investigate the clinical significance of high INR (International Normalized Ratio) values (>9) in VKA (vitamin K antagonist) treated patients with atrial fibrillation. The clinical characteristics of these patients will be studied as well as the clinical presentation. Factors influencing on high INR values will be recorded and the aim is to seek out patients who have elevated risk of bleeding complications.
Read the detailed description
This is a retrospective study setting. Source data will be collected by reviewing medical records and through computer searches. The basic study population will be identified from laboratory INR test results taken between 2003-2015.
Identifying patients with INR values over 9 will be selected for further analysis, concerning the clinical presentation, patient characteristics, 90 day survival and adverse event rates. The focus is in identifying patient characteristics and factors influencing the risk of high INR value. Also we will analyse the effects of medically reversing the high INR values on stroke and other adverse event rates. The results will be collected manually using an electronic case report form, and analysed statistically using SPSS/SAS statistics tool.
- Conditions
- Anticoagulation
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnticoagulationStudies 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
- Enrolment
- 25,000 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juhani Airaksinen, University of Turku
- Investigators
- Juhani Airaksinen, Professor, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761941
- Sponsor's protocol ID
- T80/2016
- Acronym
- EWA
- Status last verified
- May 2016
- First submitted
- 3 May 2016
- Last updated
- 5 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Excessive Warfarin Anticoagulation - Causes and Consequences
- ClinicalTrials.gov ID
- NCT02761941
- Acronym / sponsor ID
- EWA / T80/2016
- Conditions
- Anticoagulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25,000 participants (estimated)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 4 May 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.
The aim of this study is to investigate the clinical significance of high INR (International Normalized Ratio) values (>9) in VKA (vitamin K antagonist) treated patients with atrial fibrillation. The clinical characteristics of these patients will be studied as well as the clinical presentation. Factors influencing on high INR values will be recorded and the aim is to seek out patients who have elevated risk of bleeding complications.
Detailed description
This is a retrospective study setting. Source data will be collected by reviewing medical records and through computer searches. The basic study population will be identified from laboratory INR test results taken between 2003-2015.
Identifying patients with INR values over 9 will be selected for further analysis, concerning the clinical presentation, patient characteristics, 90 day survival and adverse event rates. The focus is in identifying patient characteristics and factors influencing the risk of high INR value. Also we will analyse the effects of medically reversing the high INR values on stroke and other adverse event rates. The results will be collected manually using an electronic case report form, and analysed statistically using SPSS/SAS statistics tool.
Study design
- Observational model
- Cohort
- Target follow-up
- 90 Days
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated with VKA for atrial fibrillation in the Southwest Finland hospital district area with INR value over 9.
Key inclusion criteria (1 listed)
- VKA treatment, age > 18, INR >9,
Key exclusion criteria (1 listed)
- age < 18
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
All cause mortality
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2016.
- Individual participant dataSharing planned: Undecided
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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.
Juhani Airaksinen, Professor principal investigator
Turku University Hospital
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 Anticoagulation, run by University of Turku at 1 site in Finland.
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 1 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: status not confirmed, as of the sponsor's last update on 5 May 2016. 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 Finland. 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?
Contact Tuija Vasankari, RN (+358 2 3130900, tuija.vasankari@tyks.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: 90 days). 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 5 May 2016.