Atrial FibrillationSULTANNCT02610153
Subtherapeutic INR Levels in Patients With AVK: Incidence, Associated Factors, Prognosis and Control Strategies
An observational study of Atrial Fibrillation, run by Bayer at 1 site in Spain.
Trial summary
This prospective observational study is to assess the predictive factors of poor control of international normalized ratio (INR) to determine the treatment strategies received by patients with a poor control of INR in real-life clinical practice and to explore the effectiveness and safety of these strategies in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Vitamin K Antagonist
- How many people
- 1,013 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2015to 15 Mar 2019
- 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: Adult patients diagnosed with non-valvular atrial fibrillation who are going to start vitamine K antagonist treatment or have started over the previous two months and that attend the Cardiology Units at Spanish hospitals (as outpatients).
Who may be able to join
- Patients aged ≥ 18 years.
- Patients with a diagnosis of nonvalvular atrial fibrillation according to the criteria of the Spanish Agency of Medicines and Medical Devices (AEMPS) (2013) who are treated in cardiology practices.
- Patients about to start treatment with a vitamin K antagonist or who are in the first two months of treatment.
- Patients for whom access to at least 80% of INR tests performed during treatment with vitamin K antagonists is expected to be available.
- Patients with the mental and physical capacity to complete the study questionnaires and give their informed consent to participate in the study.
Who cannot join
- Patients with mitral stenosis or another significant valve disease for which specific treatment is scheduled or has already been performed (prosthesis or valvuloplasty).
- Patients hospitalised at the time of inclusion in the study.
- Patients with a life expectancy of less than 13 months.
- Patients who are participating in a clinical trial.
- Patients receiving double antiplatelet therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Observational Study Assessing the Management of Anticoagulation With Vitamin K Antagonists in Patients With Nonvalvular Atrial Fibrillation Treated in Cardiology Practices
This prospective observational study is to assess the predictive factors of poor control of international normalized ratio (INR) to determine the treatment strategies received by patients with a poor control of INR in real-life clinical practice and to explore the effectiveness and safety of these strategies in patients with non-valvular atrial fibrillation who start vitamin K antagonist (VKA) treatment
- Conditions
- Atrial Fibrillation
- Being tested
- Vitamin K Antagonist
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin K AntagonistDrug
The vitamin K antagonists exert their anticoagulant effect through inhibition of the enzyme complex of vitamin K epoxide reductase subunit 1 with subsequent reduction of the gamma-carboxylation of certain glutamic acid molecules endpoints located on factors coagulation II (prothrombin), VII, IX and X and protein C or its cofactor protein S. This gamma-carboxylation has a significant bearing on the interaction of coagulation factors referenced with calcium ions. Without this reaction, blood clotting cannot be initiated. The dose must be adjusted to each patient at baseline and after regular basis, since the sensitivity to anticoagulants varies between individuals and can also vary throughout the treatment. For this, the Prothrombin Time (PT) is used and standardized ratio called International Normalised Ratio (INR).
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Adult patients, diagnosed with no-valvular atrial fibrillation and who have recently initiated or are going to initiate VKA treatment, that attend the Cardiology Units Receives: Drug: Vitamin K Antagonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Normalized Ratio (INR) Time in Therapeutic Range (TTR)
Percentage of time within an INR range of 2-3 estimated using the Rosendaal method
Measured: Up to 24 months
Secondary outcomes (12)
Baseline thromboembolic risk based on the CHADS2 scale
CHADS2: Cardiac failure, Hypertension, Age, Diabetes, Stroke
Measured: Baseline
Baseline thromboembolic risk based on the CHA2DS2-VASc scale
CHA2DS2-VASc:Cardiac failure, Hypertension, Age ≥75, Diabetes, Stroke -Vascular disease, Age and sex category
Measured: Baseline
Baseline haemorrhagic risk based on the HAS-BLED scale
HAS-BLED: Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly , Drugs/alcohol
Measured: Baseline
Changes in INR time in therapeutic range
INR time in therapeutic range: percentage of time within an INR range of 2-3 estimated using the Rosendaal method
Measured: Up to 24 months
Patient preferences with regard to anticoagulant treatment based on patients' questionnaires
Measured: Up to 12 months
Satisfaction with the anticoagulant treatment based on the Anti-Clot Treatment Scale (ACTS)
Measured: Up to 12 months
Adherence to the anticoagulant treatment: Morisky-Green test
Measured: Up to 12 months
Number and type of visits by patients to health professionals related to their anticoagulant treatment
Measured: Up to 12 months
Number of patients using anticoagulant treatment strategies
Strategies: patients continuing vitamin K antagonists, patients with changes/adjustments to the dose of vitamin K antagonists and patients whose treatment is changed to direct action oral anticoagulants
Measured: Up to 24 months
Number of patients treated according to clinical practice guidelines based on the Spanish Agency of Medicines and Medical Devices (AEMPS) therapeutic positioning report
Measured: Up to 24 months
Number of thromboembolic events in patients with inadequate anticoagulation management
Measured: Up to 24 months
Number of haemorrhagic events in patients with inadequate anticoagulation management
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study start1 Oct 2015
- Primary completion30 Jun 2018
- Study completion15 Mar 2019
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.
- More trials run by BayerThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,013 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610153
- Sponsor's protocol ID
- 17943
- Acronym
- SULTAN
- Status last verified
- Apr 2019
- First submitted
- 20 Oct 2015
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study Assessing the Management of Anticoagulation With Vitamin K Antagonists in Patients With Nonvalvular Atrial Fibrillation Treated in Cardiology Practices
- ClinicalTrials.gov ID
- NCT02610153
- Acronym / sponsor ID
- SULTAN / 17943
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,013 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 20 Nov 2015 (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.
This prospective observational study is to assess the predictive factors of poor control of international normalized ratio (INR) to determine the treatment strategies received by patients with a poor control of INR in real-life clinical practice and to explore the effectiveness and safety of these strategies in patients with non-valvular atrial fibrillation who start vitamin K antagonist (VKA) treatment
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: Vitamin K AntagonistAdult patients, diagnosed with no-valvular atrial fibrillation and who have recently initiated or are going to initiate VKA treatment, that attend the Cardiology Units |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with non-valvular atrial fibrillation who are going to start vitamine K antagonist treatment or have started over the previous two months and that attend the Cardiology Units at Spanish hospitals (as outpatients).
Key inclusion criteria (5 listed)
- Patients aged ≥ 18 years.
- Patients with a diagnosis of nonvalvular atrial fibrillation according to the criteria of the Spanish Agency of Medicines and Medical Devices (AEMPS) (2013) who are treated in cardiology practices.
- Patients about to start treatment with a vitamin K antagonist or who are in the first two months of treatment.
- Patients for whom access to at least 80% of INR tests performed during treatment with vitamin K antagonists is expected to be available.
- Patients with the mental and physical capacity to complete the study questionnaires and give their informed consent to participate in the study.
Key exclusion criteria (5 listed)
- Patients with mitral stenosis or another significant valve disease for which specific treatment is scheduled or has already been performed (prosthesis or valvuloplasty).
- Patients hospitalised at the time of inclusion in the study.
- Patients with a life expectancy of less than 13 months.
- Patients who are participating in a clinical trial.
- Patients receiving double antiplatelet therapy.
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 |
|---|---|---|
| Vitamin K AntagonistThe vitamin K antagonists exert their anticoagulant effect through inhibition of the enzyme complex of vitamin K epoxide reductase subunit 1 with subsequent reduction of the gamma-carboxylation of certain glutamic acid molecules endpoints located on factors coagulation II (prothrombin), VII, IX and X and protein C or its cofactor protein S. This gamma-carboxylation has a significant bearing on the interaction of coagulation factors referenced with calcium ions. Without this reaction, blood clotting cannot be initiated. The dose must be adjusted to each patient at baseline and after regular basis, since the sensitivity to anticoagulants varies between individuals and can also vary throughout the treatment. For this, the Prothrombin Time (PT) is used and standardized ratio called International Normalised Ratio (INR). | Drug | Cohort 1 |
Primary outcome
International Normalized Ratio (INR) Time in Therapeutic Range (TTR)
Time frame: Up to 24 months
Percentage of time within an INR range of 2-3 estimated using the Rosendaal method
12 secondary outcomes
Baseline thromboembolic risk based on the CHADS2 scale
Time frame: Baseline
Baseline thromboembolic risk based on the CHA2DS2-VASc scale
Time frame: Baseline
Baseline haemorrhagic risk based on the HAS-BLED scale
Time frame: Baseline
Changes in INR time in therapeutic range
Time frame: Up to 24 months
Patient preferences with regard to anticoagulant treatment based on patients' questionnaires
Time frame: Up to 12 months
Satisfaction with the anticoagulant treatment based on the Anti-Clot Treatment Scale (ACTS)
Time frame: Up to 12 months
Adherence to the anticoagulant treatment: Morisky-Green test
Time frame: Up to 12 months
Number and type of visits by patients to health professionals related to their anticoagulant treatment
Time frame: Up to 12 months
Number of patients using anticoagulant treatment strategies
Time frame: Up to 24 months
Number of patients treated according to clinical practice guidelines based on the Spanish Agency of Medicines and Medical Devices (AEMPS) therapeutic positioning report
Time frame: Up to 24 months
Number of thromboembolic events in patients with inadequate anticoagulation management
Time frame: Up to 24 months
Number of haemorrhagic events in patients with inadequate anticoagulation management
Time frame: Up to 24 months
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 25 Apr 2019.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
Bayer Study Director study director
Bayer
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 Atrial Fibrillation, run by Bayer at 1 site in Spain.
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 5 inclusion and 5 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 25 Apr 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 Spain. 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?
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?
International Normalized Ratio (INR) Time in Therapeutic Range (TTR) (time frame: Up to 24 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 25 Apr 2019.