Ischemic StrokeADHERE-OACNCT03463421
Αdherence and Persistence to Oral Anticoagulation in ΑF Patients With Previous Ischemic Stroke
An observational study of Ischemic Stroke, run by University of Thessaly at 2 sites in 2 countries.
Trial summary
The aims of this project are to: 1. investigate the adherence and persistence to anticoagulation (and in specific, to VKAs and NOACs) in AF patients with previous ischemic stroke; 2. identify predictors of poor adherence and persistence and 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- How many people
- 1,200 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jun 2018to Feb 2020
- How long will I take part?
- 3 Years
- 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: The dataset will be derived mainly from two high quality, prospective stroke registries: the Larissa Stroke Outcome Registry (LASTRO)(Larissa University Hospital, Greece) and the Helsinki Stroke Registry (Helsinki University Hospital, Finland)
Who may be able to join
- Previous ischemic stroke
- Atrial fibrillation
- Age >18 years
- Informed consent
Who cannot join
- -
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Finland1 site, 1 recruiting
- Not yet recruiting
Department of Neurology, Helsinki University Hospital, Helsinki, FinlandHelsinki University Hospital
Helsinki
Jukka Putaala, MD PhD, jukkaputaala@hus.fi
Jukka Putaala, MD PhD
Greece1 site, 1 recruiting
- Recruiting
Medical School, University of Thessaly, Larissa University Hospital
Larissa, 41110
George Ntaios, MD, PhD, 00302413502888, gntaios@med.uth.gr
George Ntaios, MD, PhD
About this study
Official title: A Prospective Assessment of Adherence and Persistence to Oral Anticoagulation in Ischemic Stroke Patients With Atrial Fibrillation: Incidence, Predictors and the Prognostic Role of the SAMe-TT2R2 Score.
The aims of this project are to:
- investigate the adherence and persistence to anticoagulation (and in specific, to VKAs and NOACs) in AF patients with previous ischemic stroke;
- identify predictors of poor adherence and persistence and
- assess whether the SAMe-TT2R2 score predicts adherence and persistence to anticoagulation
Read the detailed description
Patients with ischemic stroke and atrial fibrillation (AF) have a high risk of stroke recurrence, which is the highest among all other pathogenetic subtypes of stroke. This risk is substantially reduced with anticoagulant treatment. For many decades, vitamin-K antagonists (VKA) were the only anticoagulant choice for these patients. However, a number of limitations such as narrow therapeutic window, need for frequent INR measurements and consequent dose adjustments, risk of haemorrhagic complications, food-drug and drug-drug interactions, and others, have undermined the use of anticoagulation by both patients and physicians with apparent influence on the risk of stroke recurrence. During the last decade, four non-vitamin K antagonist oral anticoagulants (NOAC) have been successfully introduced and showed superior safety and efficacy profile than VKAs, more convenient dosing schemes (i.e. no need for adjustments) and minimum interactions with food and drugs. These advantages of NOACs vs. VKAs may have obvious implications to patient adherence to treatment and, consequently, to the efficacy of secondary stroke prevention. Nevertheless, there are only very scarce data available yet that the adherence and persistence to NOACs is higher than the adherence and persistence to VKAs in the specific population of patients with ischemic stroke and atrial fibrillation.
Recently, the SAMe-TT2R2 score has been introduced as a means to identify those AF patients who have inadequate quality of anticoagulation with VKAs expressed as Time within Therapeutic Range (TTR)5. In specific, VKA-anticoagulated AF patients with a SAMe-TT2R2 score of 0-2 are expected to have a TTR >65%, whereas patients with a score of >2 are expected to have lower TTR levels. In this context, one could hypothesize that increased SAMe-TT2R2 score may be associated with inadequate adherence and persistence to VKAs. Other parameters associated with inadequate adherence and persistence in the general AF population include education, employment, social status, and cognitive function. However, this is not well investigated in the specific population of patients with previous stroke where other conditions such as age and functional neurological status may also play an important role in adherence and persistence.
- Conditions
- Ischemic Stroke
- Keywords
- Adherence to oral anticoagulation, Persistence to oral anticoagulation, AF patients, Previous ischemic stroke
- Medical subject headings
- Ischemic Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to medication
The Adherence to Refills and Medications Scale (ARMS) will be used to assess adherence to medication. The ARMS consists of 12 items, each one representing a 4-point question. It was also designed to include two distinct subscales, and this was supported in the overall factor analysis. The 8-item medication taking subscale assesses a patient's ability to correctly self-administer the prescribed regimen. The 4-item prescription refill subscale assesses a patient's ability to refill medications on schedule. Conceptually, these represent different types of problems in medication use In the publication that introduced the ARMS score (Kripalani et al. Value Health. 2009 Jan-Feb;12(1):118-23), on the eight-item taking medications subscale, scores ranged from 8 to 29 (mean = 10.33, SD = 2.66), and in the four-item refilling medications subscale, scores from 4 to 14 were reported (mean = 5.99, SD = 1.98). Lower scores indicate better adherence.
Measured: Up to 5 years
Secondary outcomes (1)
Proportion of patients still on the initial anticoagulant at the time of follow-up assessment
Persistence to oral anticoagulation
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start1 Jun 2018
- Primary completionJun 2019 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe 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
- Other
- Enrolment
- 1,200 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki
- Responsible party
- Principal investigator, George Ntaios, University of Thessaly
- Investigators
- George Ntaios, MD, PhD, Principal investigator, Medical School, University of Thessaly, Larissa University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463421
- Sponsor's protocol ID
- ERISTA 2016
- Acronym
- ADHERE-OAC
- Status last verified
- Feb 2019
- First submitted
- 21 Feb 2018
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Assessment of Adherence and Persistence to Oral Anticoagulation in Ischemic Stroke Patients With Atrial Fibrillation: Incidence, Predictors and the Prognostic Role of the SAMe-TT2R2 Score.
- ClinicalTrials.gov ID
- NCT03463421
- Acronym / sponsor ID
- ADHERE-OAC / ERISTA 2016
- Conditions
- Ischemic Stroke
- Keywords
- Adherence to oral anticoagulation, Persistence to oral anticoagulation, AF patients, Previous ischemic stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Collaborators
- University of Helsinki
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 13 Mar 2018 (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 aims of this project are to:
- investigate the adherence and persistence to anticoagulation (and in specific, to VKAs and NOACs) in AF patients with previous ischemic stroke;
- identify predictors of poor adherence and persistence and
- assess whether the SAMe-TT2R2 score predicts adherence and persistence to anticoagulation
Detailed description
Patients with ischemic stroke and atrial fibrillation (AF) have a high risk of stroke recurrence, which is the highest among all other pathogenetic subtypes of stroke. This risk is substantially reduced with anticoagulant treatment. For many decades, vitamin-K antagonists (VKA) were the only anticoagulant choice for these patients. However, a number of limitations such as narrow therapeutic window, need for frequent INR measurements and consequent dose adjustments, risk of haemorrhagic complications, food-drug and drug-drug interactions, and others, have undermined the use of anticoagulation by both patients and physicians with apparent influence on the risk of stroke recurrence. During the last decade, four non-vitamin K antagonist oral anticoagulants (NOAC) have been successfully introduced and showed superior safety and efficacy profile than VKAs, more convenient dosing schemes (i.e. no need for adjustments) and minimum interactions with food and drugs. These advantages of NOACs vs. VKAs may have obvious implications to patient adherence to treatment and, consequently, to the efficacy of secondary stroke prevention. Nevertheless, there are only very scarce data available yet that the adherence and persistence to NOACs is higher than the adherence and persistence to VKAs in the specific population of patients with ischemic stroke and atrial fibrillation.
Recently, the SAMe-TT2R2 score has been introduced as a means to identify those AF patients who have inadequate quality of anticoagulation with VKAs expressed as Time within Therapeutic Range (TTR)5. In specific, VKA-anticoagulated AF patients with a SAMe-TT2R2 score of 0-2 are expected to have a TTR >65%, whereas patients with a score of >2 are expected to have lower TTR levels. In this context, one could hypothesize that increased SAMe-TT2R2 score may be associated with inadequate adherence and persistence to VKAs. Other parameters associated with inadequate adherence and persistence in the general AF population include education, employment, social status, and cognitive function. However, this is not well investigated in the specific population of patients with previous stroke where other conditions such as age and functional neurological status may also play an important role in adherence and persistence.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The dataset will be derived mainly from two high quality, prospective stroke registries: the Larissa Stroke Outcome Registry (LASTRO)(Larissa University Hospital, Greece) and the Helsinki Stroke Registry (Helsinki University Hospital, Finland)
Key inclusion criteria (4 listed)
- Previous ischemic stroke
- Atrial fibrillation
- Age >18 years
- Informed consent
Key exclusion criteria (1 listed)
- -
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
Adherence to medication
Time frame: Up to 5 years
The Adherence to Refills and Medications Scale (ARMS) will be used to assess adherence to medication. The ARMS consists of 12 items, each one representing a 4-point question. It was also designed to include two distinct subscales, and this was supported in the overall factor analysis. The 8-item medication taking subscale assesses a patient's ability to correctly self-administer the prescribed regimen. The 4-item prescription refill subscale assesses a patient's ability to refill medications on schedule. Conceptually, these represent different types of problems in medication use In the publication that introduced the ARMS score (Kripalani et al. Value Health. 2009 Jan-Feb;12(1):118-23), on the eight-item taking medications subscale, scores ranged from 8 to 29 (mean = 10.33, SD = 2.66), and in the four-item refilling medications subscale, scores from 4 to 14 were reported (mean = 5.99, SD = 1.98). Lower scores indicate better adherence.
1 secondary outcome
Proportion of patients still on the initial anticoagulant at the time of follow-up assessment
Time frame: Up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
- 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.
George Ntaios, MD, PhD principal investigator
Medical School, University of Thessaly, Larissa University Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by University of Thessaly at 2 sites in 2 countries.
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: status not confirmed, as of the sponsor's last update on 11 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland, Greece. 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 George Ntaios, MD, PhD (00302413502888, gntaios@med.uth.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to medication (time frame: Up to 5 years). 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 11 Feb 2019.