Clinical trial NCT03463421: Αdherence and Persistence to Oral Anticoagulation in ΑF Patients With Previous Ischemic Stroke
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Stroke
Keywords: Adherence to oral anticoagulation
Persistence to oral anticoagulation
AF patients
Previous ischemic stroke
Lead sponsor: University of Thessaly
Sponsor class: OTHER
Collaborators: name: University of Helsinki
First posted: 2018-03-13
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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)

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Previous ischemic stroke
* Atrial fibrillation
* Age \>18 years
* Informed consent

Exclusion Criteria:

-

Primary outcomes:
measure: Adherence to medication
timeFrame: Up to 5 years
Secondary outcomes:
measure: Proportion of patients still on the initial anticoagulant at the time of follow-up assessment
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Department of Neurology, Helsinki University Hospital, Helsinki, FinlandHelsinki University Hospital
city: Larissa
country: Greece
facility: Medical School, University of Thessaly, Larissa University Hospital
Study officials:
affiliation: Medical School, University of Thessaly, Larissa University Hospital
name: George Ntaios, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: