Αdherence and Persistence to Oral Anticoagulation in ΑF Patients With Previous Ischemic Stroke

Ischemic Stroke Clinical Trial

— ADHERE-OAC  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03463421
• Other study ID #: ERISTA 2016
• Status: Recruiting
• Start date: June 1, 2018
• Est. completion date: February 2020

Study information

• Verified date: February 2019
• Source: University of Thessaly
• Contact: George Ntaios, MD, PhD
• Phone: 00302413502888
• Email: gntaios[@]med.uth.gr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. assess whether the SAMe-TT2R2 score predicts adherence and persistence to anticoagulation

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: February 2020
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Previous ischemic stroke

• Atrial fibrillation

• Age >18 years

• Informed consent

Exclusion Criteria:

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
Finland	Department of Neurology, Helsinki University Hospital, Helsinki, FinlandHelsinki University Hospital	Helsinki
Greece	Medical School, University of Thessaly, Larissa University Hospital	Larissa

Sponsors (2)

Lead Sponsor	Collaborator
University of Thessaly	Helsinki University

Countries where clinical trial is conducted

Finland,  Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 5 years
Secondary	Proportion of patients still on the initial anticoagulant at the time of follow-up assessment	Persistence to oral anticoagulation	Up to 5 years